Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03870893
• Collaborator: National Research Foundation of Korea (Other)
• Enrollment: 47
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.8
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

This research analyzes whether hippotherapy improves the physical activity, cardiopulmonary fitness, and attention in children with cerebral palsy and whether this enhances their general health and quality of life.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy; Physical Activity; Attention Disorder	Behavioral: hippotherapy	N/A

Detailed Description

This research aims to promote hippotherapy by scientifically proving its therapeutic effects and mechanism to contribute to improving the health and quality of life of the patients as well as reducing their global burden of disease by shifting the current passive "therapy-oriented" paradigm to a more proactive "participation-oriented" paradigm.

Ever since physical activity and physical fitness have been reported to have an inverse relationship with the mortality rate, especially deaths due to cardiovascular disease, various efforts have been made to optimize physical activity and physical fitness among children with cerebral palsy. ADHD is one of the most common coexisting conditions of cerebral palsy. More participation in engaging sports activities like therapeutic riding is anticipated to improve patient health and their quality of life.

Hippotherapy is expected to improve clinical symptom of ADHD in children with cerebral palsy while preventing possible ensuing psychiatric disorders, thereby bringing significant improvement in their health and quality of life.

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Hippotherapy on Physical Activities, Cardiopulmonary Fitness and Attention in Children With Cerebral Palsy
• Actual Study Start Date: Jul 5, 2017
• Actual Primary Completion Date: Feb 28, 2020
• Actual Study Completion Date: Feb 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Intervention is administered to patients in this Arm.	Behavioral: hippotherapy; 16weeks hippotherapy program
No Intervention: control group No intervention

Outcome Measures

Primary Outcome Measures

1. Change of Clinical Global Improvement(CGI) [Change in baseline CGI at 16weeks]

   The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Lower values represent a better outcome. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as 1= very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Higher values represent a better outcome.

Secondary Outcome Measures

1. Change of Attention [Change in baseline attention at 16weeks]

   Child Behavior Checklist; The Social Ability Scale consists of Sociality Scale and Academic Performance Scale. The Scale of Problem Behavior Syndrome consists of 113 items related to problem behavior, and 13 (Sociality, Learning Problem, Total Social Ability, Atrophy, Depression, social immaturity, thinking problems, attention problems, flying, aggression, internalization problems, externalizing problems, total problem behaviors). For each question, the scale is to be rated as 3-point Likert scale, the raw scores of all subscales are converted to standardized T scores . The higher the score, the higher the tendency toward problem behavior.

2. Change of Physical Activity(%) [Change in baseline physical activity at 16weeks]

   The %sedentary physical activity(%SPA), %light physical activity(%LPA), %moderate physical activity(%MPA), %vigorous physical activity(%VPA) during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA).

3. Change of Peak Oxygen Uptake(VO2peak) [Change in baseline peak oxygen uptake at 16weeks]

   peak oxygen uptake(ml/kg/min) is a category of physical fitness, which is measured during graded submaximal exercise test. Higher values represent a better outcome.

4. Change of Gross Motor Function Measure 66 [Change in baseline Gross Motor Function Measure 66 at 16weeks]

   GMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. The score of each dimension is expressed as a percentage of the maximum score. The GMFM-66, which includes 66 items of the original 88 items. Item scoring is the same for the GMFM-88 and the GMFM-66. There is a scoring system with each item scored as 0, 1, 2, 3, or "not tested". A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. Scoring the GMFM-66 requires the use of a computer program called the Gross Motor Ability Estimator (GMAE). Individual item scores are entered and a mathematical algorithm calculates an interval level total score. The total score is an estimate of the child's gross motor function. The range of total score in GMFM-66 is from 0 to 100. The range of % in GMFM-88 is from 0 to 100. Higher values represent a better outcome.

5. Change of Physical Activity(Steps) [Change in baseline steps at 16weeks]

   Steps(counts) was measured during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA)

6. Change of Resting Heart Rate(RHR) [Change in baseline resting heart rate at 16weeks]

   Resting heart rate(beats/min) is a category of physical fitness, which is measured during graded submaximal exercise test. A normal resting heart rate for adults ranges from 60 to 100 beats per minute. Generally, a lower heart rate at rest implies more efficient heart function and better cardiovascular fitness.

7. Change of Respiratory Exchange Ratio(RER) [Change in baseline respiratory exchange ratio at 16weeks]

   All patients performed a symptom-limited, treadmill exercise test using the Modified Naughton protocol. Respiratory exchange ratio(RER) were measured with a gas analyzer. RER is the ratio between the amount of carbon dioxide (CO2) produced in metabolism and oxygen (O2) used. A high RER (RER values≥1) indicates that carbohydrates are being predominantly used, whereas a low RER (RER values<1) suggests lipid oxidation.

8. Change of Heart Rate Recovery(HRR) [Change in baseline heart rate recovery at 16weeks]

   All patients performed a symptom-limited, treadmill exercise test using the Modified Naughton protocol. In the recovery period, the patients walked for 2 minutes at a speed of 1.9 km/h and a grade of 0% and then sat down in a chair for the last 3 minutes (recovery). The Heart rate recovery (HRR) was defined as the difference between peak HR during the test and HR at 1 (HRR1), 3 (HRR3), and 5 (HRR5) minutes.

9. Change of Children Health Questionnaire Parent Form 50 (CHQ-PF50) [Change in baseline child health questionnaire-parent form 50 at 16weeks]

   The Child Health Questionnaire™ (CHQ) is a family of generic person-reported outcomes measures to assess health-related quality of life for children and adolescents from 5-to-18 years of age. Child Health Questionnaire Parent Form 50 (CHQ-PF50) Questions; total 50 questions, 4 or 6 score Likert scale, the score range is from 0 to 100, higher values represent a better outcome. Scores can be analyzed at combined to derive an overall physical and psychosocial score, (CHQ Summary Scores).

10. Change of Timed up and go(TUG) [Change in baseline timed up and go at 16weeks]

    ① Stand up from the chair without support. ② Walk 3m from chair. ③ Turn around. ④ Sit back in the chair. Measure the time(second), higher values represent a worse outcome. Lower values represent a better outcome.

11. Change of 6 Minute Walk Test(6MWT) [Change in baseline 6 minute walk test at 16weeks]

    The 6 minute walk test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity and endurance. Higher values represent a better outcome.

12. Change of Blood Pressure(BP) [Change in baseline blood pressure at 16weeks]

    Blood pressure(mmHg) measured before graded exercise test using treadmill.

13. Change of Pediatric Balance Scale(PBS) [Change in baseline pediatric balance scale at 16weeks]

    PBS is a functional balance scale adapted and customized from Berg Balance Scale for use with children. The PBS has been used initially to measure the balance functions for school-age children with mild-to-moderate motor impairments. The PBS is a 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks. It can easily be administered and scored in less than 20 minutes using equipment commonly found in schools and clinics. Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. The range of total score is from 0 to 56. Higher values represent a better outcome.

14. Change of Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale [Change in baseline ADHD rating scale at 16weeks]

    ADHD(attention deficit hyperactivity disorder) rating scale; total 18 questions. Each item is scored from 0-3 points, The treatment effect is evaluated using Total score(0 ~ 54 points),attention-deficit scores (0 ~ 27 points) and hyperactivity/impulsivity score (0 ~ 27 points)

15. Change of Self-Esteem Scale [Change in baseline self-esteem at 16weeks]

    Self-Esteem Scale; total 10 question, Each item is scored from 1-4 points. Five of the ten questions are positive and five are negative. In the positive item, 1 = 'almost not so' and 4 = 'always'. In the negative item, the scores range from 10 to 40. The treatment effect is evaluated using the total score.

16. Change of PedsQL 4.0 [Change in baseline quality life of child at 16weeks]

    PedsQL 4.0; total 23 questions; Each item is scored from 0-4 points and scores are transformed on a scale from 0 to 100. Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Thus, the scores range from 0 to 2300, higher values represent a better outcome.

17. Change of Continuous Performance Test 3rd Edition [Change in baseline attention at 16weeks]

    Continuous Performance Test 3rd edition; It is a computerized assessment tool designed to measure attention-related problems, instructing them to respond to all stimuli except alphabet X, and instructing them to perform as accurately and quickly as possible. Detectability, Omission Errors, Commission Errors, Perseverations, HRT(hit reaction time), HRT SD (standard deviation), Variability, HRT Block Change, HRT ISI Change are used to assess respondents' performance on inattentiveness, impulsivity, sustained attention, and vigilance. It is used 9 T-scores to assess the level of attention problem.

18. Change of Quantitative Electroencephalography [Change in baseline Quantitative electroencephalography at 16weeks]

    An electroencephalogram (EEG) is a test that detects electrical activity in your brain using small, metal discs(electrodes) attached to your scalp. Your brain cells communicate via electrical impulses and are active all the time. This activity shows up as wave lines on an EEG recording. It is using Neuroscan Synamp2 amplifier(Compumedics USA, El Paso, TX, USA). For quantitative analysis, EEG without a handwriting is digitized by Fast Fourier Transformation. The square root of the magnitude of the EEG was calculated as the microvolt (uV) value, and the relative power is defined as the electrical force of the specific region divided by the electrical force in the whole region. The relative power of delta, theta, alpha, and beta waves and theta/beta ratio measured at the Fz, Cz, Pz electrode are used for the analysis. The value of theta/beta ratio is average as it approaches 0 and deviates from the mean as it gets away from 0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosis of spastic CP

• GMFCS level I-III

• weight < 35kg

• ability to walk independently with or without an assistive device

• ability to comply with the study protocol and follow verbal directions

Exclusion Criteria:

• botulinum toxin injection within 3 months

• orthopedic surgery within 1 year (difficulty performing one step instructions)

• moderate to severe intellectual disability

• uncontrolled seizure

• poor visual or hearing acuity

• patients who weigh more than 35 kg

• hip dislocation

• scoliosis more than 30 degrees

• musculoskeletal surgery within 1 year

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

• Samsung Medical Center
• National Research Foundation of Korea

Investigators

• Principal Investigator: Minhwa Suk, Researcher

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 26, 2017

More Information

Publications

None provided.

• Responsible Party: Jeong Yi Kwon, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03870893
• Other Study ID Numbers: 2017-0665-000
• First Posted: Mar 12, 2019
• Last Update Posted: Aug 5, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jeong Yi Kwon, Professor, Samsung Medical Center: cerebral palsy; hippotherapy; cardiopulmonary fitness; physical activity; attention
• Additional relevant MeSH terms: Paralysis; Cerebral Palsy; Cognition Disorders

Study Results

Participant Flow

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention.
Period Title: Overall Study
STARTED	23	24
COMPLETED	23	23
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Intervention Group	Control Group	Total
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention	Total of all reporting groups
Overall Participants	23	23	46
Age (Count of Participants)
<=18 years	23 100%	23 100%	46 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.74 (1.63)	7.22 (1.48)	7.48 (1.56)
Sex: Female, Male (Count of Participants)
Female	11 47.8%	11 47.8%	22 47.8%
Male	12 52.2%	12 52.2%	24 52.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	23 100%	23 100%	46 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
South Korea	23 100%	23 100%	46 100%

Outcome Measures

1. Primary Outcome

Title	Change of Clinical Global Improvement(CGI)
Description	The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Lower values represent a better outcome. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as 1= very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Higher values represent a better outcome.
Time Frame	Change in baseline CGI at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	23	23
Change of CGI-S	-0.13 (0.46)	-0.09 (0.29)
Change of CGI-I	2.65 (0.78)	3.87 (0.46)

2. Secondary Outcome

Title	Change of Attention
Description	Child Behavior Checklist; The Social Ability Scale consists of Sociality Scale and Academic Performance Scale. The Scale of Problem Behavior Syndrome consists of 113 items related to problem behavior, and 13 (Sociality, Learning Problem, Total Social Ability, Atrophy, Depression, social immaturity, thinking problems, attention problems, flying, aggression, internalization problems, externalizing problems, total problem behaviors). For each question, the scale is to be rated as 3-point Likert scale, the raw scores of all subscales are converted to standardized T scores . The higher the score, the higher the tendency toward problem behavior.
Time Frame	Change in baseline attention at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	23	23
Total problems(pre)	57.52 (9.08)	57.70 (7.15)
Total problems(post)	54.61 (11.63)	55.39 (7.55)

3. Secondary Outcome

Title	Change of Physical Activity(%)
Description	The %sedentary physical activity(%SPA), %light physical activity(%LPA), %moderate physical activity(%MPA), %vigorous physical activity(%VPA) during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA).
Time Frame	Change in baseline physical activity at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions) in addition to conventional physiotherapy.	No intervention
Measure Participants	23	23
Change of %SPA	1.86 (5.07)	-0.61 (4.86)
Change of %LPA	-1.58 (4.41)	0.24 (3.74)
Change of %MPA	-0.28 (0.67)	0.13 (1.00)
Change of %VPA	0.00 (0.53)	0.25 (0.75)

4. Secondary Outcome

Title	Change of Peak Oxygen Uptake(VO2peak)
Description	peak oxygen uptake(ml/kg/min) is a category of physical fitness, which is measured during graded submaximal exercise test. Higher values represent a better outcome.
Time Frame	Change in baseline peak oxygen uptake at 16weeks

Outcome Measure Data

Analysis Population Description

Five Participants want to stop during measurement (Intervention group -> 3 participants; Control group -> 2 participants)

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions) in addition to conventional physiotherapy.	No intervention
Measure Participants	20	21
Mean (Standard Deviation) [ml/kg/min]	1.84 (4.33)	-0.09 (3.57)

5. Secondary Outcome

Title	Change of Gross Motor Function Measure 66
Description	GMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. The score of each dimension is expressed as a percentage of the maximum score. The GMFM-66, which includes 66 items of the original 88 items. Item scoring is the same for the GMFM-88 and the GMFM-66. There is a scoring system with each item scored as 0, 1, 2, 3, or "not tested". A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. Scoring the GMFM-66 requires the use of a computer program called the Gross Motor Ability Estimator (GMAE). Individual item scores are entered and a mathematical algorithm calculates an interval level total score. The total score is an estimate of the child's gross motor function. The range of total score in GMFM-66 is from 0 to 100. The range of % in GMFM-88 is from 0 to 100. Higher values represent a better outcome.
Time Frame	Change in baseline Gross Motor Function Measure 66 at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions) in addition to conventional physiotherapy.	No intervention
Measure Participants	23	23
Mean (Standard Deviation) [scores on a scale]	2.24 (2.32)	0.81 (0.97)

6. Secondary Outcome

Title	Change of Physical Activity(Steps)
Description	Steps(counts) was measured during the day using ActiGraph(model GT3X, ActiGraph, Pensacola, FL, USA)
Time Frame	Change in baseline steps at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	23	23
Mean (Standard Deviation) [step counts per minute]	-37.97 (140.50)	20.94 (180.53)

7. Secondary Outcome

Title	Change of Resting Heart Rate(RHR)
Description	Resting heart rate(beats/min) is a category of physical fitness, which is measured during graded submaximal exercise test. A normal resting heart rate for adults ranges from 60 to 100 beats per minute. Generally, a lower heart rate at rest implies more efficient heart function and better cardiovascular fitness.
Time Frame	Change in baseline resting heart rate at 16weeks

Outcome Measure Data

Analysis Population Description

Participants want to stop during measurement (Intervention group -> 3 participants; Control group -> 2 participants)

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions) in addition to conventional physiotherapy.	No intervention
Measure Participants	20	21
Mean (Standard Deviation) [beats per minute]	-12.40 (11.98)	-0.62 (8.41)

8. Secondary Outcome

Title	Change of Respiratory Exchange Ratio(RER)
Description	All patients performed a symptom-limited, treadmill exercise test using the Modified Naughton protocol. Respiratory exchange ratio(RER) were measured with a gas analyzer. RER is the ratio between the amount of carbon dioxide (CO2) produced in metabolism and oxygen (O2) used. A high RER (RER values≥1) indicates that carbohydrates are being predominantly used, whereas a low RER (RER values<1) suggests lipid oxidation.
Time Frame	Change in baseline respiratory exchange ratio at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	20	21
Mean (Standard Deviation) [Ratio]	0.04 (0.05)	0.01 (0.05)

9. Secondary Outcome

Title	Change of Heart Rate Recovery(HRR)
Description	All patients performed a symptom-limited, treadmill exercise test using the Modified Naughton protocol. In the recovery period, the patients walked for 2 minutes at a speed of 1.9 km/h and a grade of 0% and then sat down in a chair for the last 3 minutes (recovery). The Heart rate recovery (HRR) was defined as the difference between peak HR during the test and HR at 1 (HRR1), 3 (HRR3), and 5 (HRR5) minutes.
Time Frame	Change in baseline heart rate recovery at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	13	13
Change of heart rate recovery 1	6.54 (6.34)	-2.15 (5.20)
Change of heart rate recovery3	13.38 (12.92)	-5.54 (5.81)
Change of heart rate recovery5	11.15 (11.42)	-3.80 (7.07)

10. Secondary Outcome

Title	Change of Children Health Questionnaire Parent Form 50 (CHQ-PF50)
Description	The Child Health Questionnaire™ (CHQ) is a family of generic person-reported outcomes measures to assess health-related quality of life for children and adolescents from 5-to-18 years of age. Child Health Questionnaire Parent Form 50 (CHQ-PF50) Questions; total 50 questions, 4 or 6 score Likert scale, the score range is from 0 to 100, higher values represent a better outcome. Scores can be analyzed at combined to derive an overall physical and psychosocial score, (CHQ Summary Scores).
Time Frame	Change in baseline child health questionnaire-parent form 50 at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	23	23
Summary score(Physical)	2.73 (7.42)	2.08 (7.78)
Summary score(Psychosocial)	3.31 (7.78)	2.50 (6.65)

11. Secondary Outcome

Title	Change of Timed up and go(TUG)
Description	① Stand up from the chair without support. ② Walk 3m from chair. ③ Turn around. ④ Sit back in the chair. Measure the time(second), higher values represent a worse outcome. Lower values represent a better outcome.
Time Frame	Change in baseline timed up and go at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	23	23
Mean (Standard Deviation) [seconds]	-1.55 (1.19)	-1.33 (3.64)

12. Secondary Outcome

Title	Change of 6 Minute Walk Test(6MWT)
Description	The 6 minute walk test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity and endurance. Higher values represent a better outcome.
Time Frame	Change in baseline 6 minute walk test at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	23	23
Mean (Standard Deviation) [meters]	37.22 (49.52)	13.43 (37.47)

13. Secondary Outcome

Title	Change of Blood Pressure(BP)
Description	Blood pressure(mmHg) measured before graded exercise test using treadmill.
Time Frame	Change in baseline blood pressure at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	20	21
Change of SBP	-1.30 (7.03)	0.05 (6.29)
Change of DBP	-1.55 (8.22)	0.52 (7.73)

14. Secondary Outcome

Title	Change of Pediatric Balance Scale(PBS)
Description	PBS is a functional balance scale adapted and customized from Berg Balance Scale for use with children. The PBS has been used initially to measure the balance functions for school-age children with mild-to-moderate motor impairments. The PBS is a 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks. It can easily be administered and scored in less than 20 minutes using equipment commonly found in schools and clinics. Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. The range of total score is from 0 to 56. Higher values represent a better outcome.
Time Frame	Change in baseline pediatric balance scale at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	23	23
Mean (Standard Deviation) [score on a scale]	2.48 (2.00)	0.30 (0.88)

15. Secondary Outcome

Title	Change of Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale
Description	ADHD(attention deficit hyperactivity disorder) rating scale; total 18 questions. Each item is scored from 0-3 points, The treatment effect is evaluated using Total score(0 ~ 54 points),attention-deficit scores (0 ~ 27 points) and hyperactivity/impulsivity score (0 ~ 27 points)
Time Frame	Change in baseline ADHD rating scale at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	23	23
Total score(pre)	12.22 (8.66)	11.13 (8.32)
Total score(post)	11.17 (8.32)	10.26 (8.20)

16. Secondary Outcome

Title	Change of Self-Esteem Scale
Description	Self-Esteem Scale; total 10 question, Each item is scored from 1-4 points. Five of the ten questions are positive and five are negative. In the positive item, 1 = 'almost not so' and 4 = 'always'. In the negative item, the scores range from 10 to 40. The treatment effect is evaluated using the total score.
Time Frame	Change in baseline self-esteem at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions) in addition to conventional physiotherapy.	No intervention
Measure Participants	23	23
Pre-test outcome	31.22 (4.34)	32.48 (2.81)
Post-test outcome	32.35 (3.61)	33.34 (3.72)

17. Secondary Outcome

Title	Change of PedsQL 4.0
Description	PedsQL 4.0; total 23 questions; Each item is scored from 0-4 points and scores are transformed on a scale from 0 to 100. Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Thus, the scores range from 0 to 2300, higher values represent a better outcome.
Time Frame	Change in baseline quality life of child at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	23	23
Physical functioning(pre)	60.73 (19.21)	65.90 (18.15)
Physical functioning(post)	69.70 (15.81)	77.85 (15.10)
Emotional functioning(pre)	70.22 (24.84)	69.57 (27.67)
Emotional functioning(post)	79.13 (20.49)	82.17 (16.98)
Social functioning(pre)	58.48 (28.14)	61.30 (27019)
Social functioning(post)	74.13 (16.90)	80.65 (22.02)
School functioning(pre)	69.35 (22.98)	72.39 (24.67)
School functioning(post)	74.13 (18.99)	85.44 (12.33)

18. Secondary Outcome

Title	Change of Continuous Performance Test 3rd Edition
Description	Continuous Performance Test 3rd edition; It is a computerized assessment tool designed to measure attention-related problems, instructing them to respond to all stimuli except alphabet X, and instructing them to perform as accurately and quickly as possible. Detectability, Omission Errors, Commission Errors, Perseverations, HRT(hit reaction time), HRT SD (standard deviation), Variability, HRT Block Change, HRT ISI Change are used to assess respondents' performance on inattentiveness, impulsivity, sustained attention, and vigilance. It is used 9 T-scores to assess the level of attention problem.
Time Frame	Change in baseline attention at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	23	23
detectability(pre)	59.00 (7.62)	54.00 (7.76)
detectability(post)	52.57 (10.23)	49.61 (8.11)
Omissions(pre)	71.70 (16.66)	59.91 (11.29)
Omissions(post)	67.13 (18.61)	57.91 (14.84)
Commisions(pre)	48.74 (9.90)	46.65 (9.47)
Commisions(post)	42.96 (7.50)	43.13 (7.24)
Perseveration(pre)	61.30 (13.65)	51.57 (8.77)
Perseveration(post)	53.04 (8.22)	49.91 (6.82)
hit reaction time(pre)	69.87 (14.75)	65.04 (11.31)
hit reaction time(post)	70.04 (14.22)	65.70 (12.31)
standard deviation of hit reaction time(pre)	65.74 (12.08)	55.83 (10.18)
standard deviation of hit reaction time(post)	60.78 (12.14)	55.04 (9.77)

19. Secondary Outcome

Title	Change of Quantitative Electroencephalography
Description	An electroencephalogram (EEG) is a test that detects electrical activity in your brain using small, metal discs(electrodes) attached to your scalp. Your brain cells communicate via electrical impulses and are active all the time. This activity shows up as wave lines on an EEG recording. It is using Neuroscan Synamp2 amplifier(Compumedics USA, El Paso, TX, USA). For quantitative analysis, EEG without a handwriting is digitized by Fast Fourier Transformation. The square root of the magnitude of the EEG was calculated as the microvolt (uV) value, and the relative power is defined as the electrical force of the specific region divided by the electrical force in the whole region. The relative power of delta, theta, alpha, and beta waves and theta/beta ratio measured at the Fz, Cz, Pz electrode are used for the analysis. The value of theta/beta ratio is average as it approaches 0 and deviates from the mean as it gets away from 0.
Time Frame	Change in baseline Quantitative electroencephalography at 16weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group	Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions).	No intervention
Measure Participants	23	23
Fz(pre)	0.384 (0.961)	-0.046 (0.910)
Fz(post)	0.522 (0.835)	-0.098 (0.826)
Cz(pre)	0.501 (1.420)	0.058 (0.883)
Cz(post)	0.274 (0.933)	0.342 (0.760)
Pz(pre)	0.077 (0.857)	-0.130 (0.980)
Pz(post)	0.240 (1.141)	-0.156 (0.730)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Hippotherapy were conducted by three therapeutic riding instructors. One leader and two side walkers walked with a horse, and all participants wore helmets. The intensity of the exercises and degree of assistance were individualized according to the participants' ability to control their body and horse. The horse/ponies were very experienced in Hippotherapy settings.
Arm/Group Title	Intervention Group		Control Group
Arm/Group Description	Children participated in Hippotherapy for 40 minutes per lesson twice a week for 16 weeks (total of 32 sessions) in addition to conventional physiotherapy.		No intervention.
All Cause Mortality
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Serious Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.