Hippotherapy Simulator in Children With Cerebral Palsy

Sponsor

Marmara University (Other)

Overall Status

Completed

CT.gov ID

NCT04378036

Collaborator

(none)

Enrollment

Location

Arms

10.4

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study was to research the effects of hippotherapy simulator in children with Cerebral Palsy. In order to evaluate its effectiveness, assessment of gross motor functions, lower extremity functions, muscle tone and spasticity, trunk control, sitting and standing balance, walking functions and functional independence were being applied.

Condition or Disease	Intervention/Treatment	Phase
Rehabilitation Cerebral Palsy, Spastic	Other: Neurodevelopmental Therapy Device: Hippotherapy Simulator	N/A

Detailed Description

"Cerebral Palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that is attributed to nonprogressive disturbances that occurred in the developing fetal or infant brain." The motor disorders of CP are often accompanied by disturbances of sensation, perception, cognition, communication, and behavior, by epilepsy, and by secondary musculoskeletal problems.

CP is the most common neurodevelopmental disorder that begins in early childhood, continues for life and causes physical impairment. Damage occurring in the developing brain results in voluntary movement, postural and motor control disorders, balance problems and gait disorders.

Hippotherapy is used effectively in increasing the participation of children with CP by improving their balance, motor function, posture and mobility and improving their quality of life. Although hippotherapy has many physical, functional, emotional and social benefits for children with CP, it also has some disadvantages that limit its use in the treatment of these children. There are risks such as serious injuries caused by children being afraid of a horse, falling from a horse or kicking a horse, increased hypertonicity due to fear and stress on the horse and exposure to allergic reactions due to environmental antigens. In order to overcome these conditions and reach more patients, hippotherapy simulator systems, which have been increasing rapidly in recent years, have been developed.

Hippotherapy simulators are systems that mimic the walking and movements of a real horse. As they are a newly developed system, studies investigating their effectiveness, especially in children with CP, are very limited. The aim of this study is to research the effects of hippotherapy simulator on gross motor functions, lower extremity functions, muscle tone and spasticity, trunk control, sitting and standing balance, walking functions and functional independence in children with Cerebral Palsy.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two different treatment methods were applied to the participants (n=30). Rehabilitation programs based on individual Neurodevelopmental Therapy were applied to the participants included in the study for eight weeks (first group). In the next eight weeks, the Hippotherapy Simulator system was applied to the same participants in addition to individual Neurodevelopmental Therapy-based rehabilitation programs (study group).Two different treatment methods were applied to the participants (n=30). Rehabilitation programs based on individual Neurodevelopmental Therapy were applied to the participants included in the study for eight weeks (first group). In the next eight weeks, the Hippotherapy Simulator system was applied to the same participants in addition to individual Neurodevelopmental Therapy-based rehabilitation programs (study group).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effects of a Hippotherapy Simulator in Children With Cerebral Palsy

Actual Study Start Date :

Dec 14, 2016

Actual Primary Completion Date :

Oct 28, 2017

Actual Study Completion Date :

Oct 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Neurodevelopmental Therapy Group The number of participants in this group is 30. All participants were included in the rehabilitation program using only the Neurodevelopmental Therapy approach for 16 sessions (8 weeks x 2 days x 45 minutes).	Other: Neurodevelopmental Therapy The Neurodevelopmental Therapy rehabilitation program was determined according to the children's level of gross motor function, age, gender, mental state, and preferences. Neurodevelopmental Therapy program consists of the rehabilitation of muscle tone disorders, increasing sensory-perception-motor integrity, exercises to increase limb functions and body control, stretching and strengthening exercises for muscle shortness and weakness, exercises that include movements in daily life and training activities such as standing, walking, body care.
Active Comparator: Hippotherapy Simulator Group The same participants were taken into a rehabilitation program in which 16 sessions (8 weeks x 2 days a week) the Hippotherapy Simulator device (30 minutes) and Neurodevelopmental Therapy (NDT) (15 minutes) (HS + NDT method) were used together.	Other: Neurodevelopmental Therapy The Neurodevelopmental Therapy rehabilitation program was determined according to the children's level of gross motor function, age, gender, mental state, and preferences. Neurodevelopmental Therapy program consists of the rehabilitation of muscle tone disorders, increasing sensory-perception-motor integrity, exercises to increase limb functions and body control, stretching and strengthening exercises for muscle shortness and weakness, exercises that include movements in daily life and training activities such as standing, walking, body care. Device: Hippotherapy Simulator Horse Riding Simulator (HRS) device was used as a hippotherapy simulator device. HRS is a device that moves forward, backward, backward-to-back, right-to-left swing and up-and-down swing in 3 dimensions, similar to the movements of a real horse, forming an 8-shaped movement on five axes. After the children sat in the saddle section, they were first taken to the warm-up speed program for 5 minutes, then to another one of the other speed levels (gradually moved to other speed levels as appropriate for the development and tolerance of children) and finally to the warm-up speed program for 5 minutes.

Arm

Intervention/Treatment

Active Comparator: Neurodevelopmental Therapy Group

The number of participants in this group is 30. All participants were included in the rehabilitation program using only the Neurodevelopmental Therapy approach for 16 sessions (8 weeks x 2 days x 45 minutes).

Other: Neurodevelopmental Therapy

The Neurodevelopmental Therapy rehabilitation program was determined according to the children's level of gross motor function, age, gender, mental state, and preferences. Neurodevelopmental Therapy program consists of the rehabilitation of muscle tone disorders, increasing sensory-perception-motor integrity, exercises to increase limb functions and body control, stretching and strengthening exercises for muscle shortness and weakness, exercises that include movements in daily life and training activities such as standing, walking, body care.

Active Comparator: Hippotherapy Simulator Group

The same participants were taken into a rehabilitation program in which 16 sessions (8 weeks x 2 days a week) the Hippotherapy Simulator device (30 minutes) and Neurodevelopmental Therapy (NDT) (15 minutes) (HS + NDT method) were used together.

Other: Neurodevelopmental Therapy

Device: Hippotherapy Simulator

Horse Riding Simulator (HRS) device was used as a hippotherapy simulator device. HRS is a device that moves forward, backward, backward-to-back, right-to-left swing and up-and-down swing in 3 dimensions, similar to the movements of a real horse, forming an 8-shaped movement on five axes. After the children sat in the saddle section, they were first taken to the warm-up speed program for 5 minutes, then to another one of the other speed levels (gradually moved to other speed levels as appropriate for the development and tolerance of children) and finally to the warm-up speed program for 5 minutes.

Outcome Measures

Primary Outcome Measures

Gross Motor Function Classification System (GMFSS) [Baseline]
Functional levels of participants were determined with the "Gross Motor Function Classification System" (GMFSS) before treatment. It is a system that classifies the gross motor functions of children with cerebral palsy. It classifies gross motor functions into five levels.
Change in gross motor function from baseline to week 8 to week 16 [baseline, 8th. week, 16th. week]
The gross motor functions of the participants were evaluated using Gross Motor Function Measure-88 (GMFM-88) before treatment, in the 8th week and the 16th week. It is a valid and reliable assessment tool widely used to evaluate motor functions in children with cerebral palsy. It consists of 88 items and includes 5 subsections: (A) lying and Rolling; (B) sitting; (C) crawling and kneeling; (D) standing; (E) walking, running and jumping.
Change in range of motion from baseline to week 8 to week 16 [baseline, 8th. week, 16th. week]
The range of motion of the joints in the lower extremities was measured using the universal goniometer before treatment, in the 8th week and the 16th week.
Change in spasticity from baseline to week 8 to week 16 [baseline, 8th. week, 16th. week]
Muscle spasticity of the lower limbs was evaluated with Modified Ashworth Scale (MAS) before treatment, in the 8th week and the 16th week. In the evaluations made with MAS, the muscle tone is rated between "0" and "4". "0" indicates that there is no increase in muscle tone, and "4" indicates that the affected part is rigid in flexion and extension.
Change in muscle tones of lower extremities from baseline to week 8 to week 16 [baseline, 8th. week, 16th. week]
The tone, stiffness, and flexibility of the lower limb muscles were evaluated with the Myoton®PRO Digital Palpation Device before treatment, in the 8th week and the 16th week. It is an evidence-based Class 1 device (MDD Annex IX) that evaluates the biomechanical properties of soft biological tissues non-invasively, objectively, reliably, cheaply, quickly and easily.
Change in trunk postural control from baseline to week 8 to week 16 [baseline, 8th. week, 16th. week]
The functional strength of the trunk, postural control and quality of trunk movements were evaluated with The Trunk Impairment Scale (TIS) before treatment, in the 8th week and the 16th week. TIS has been developed to evaluate the trunk of individuals with stroke and is a scale that has been adapted for use with children with cerebral palsy. TIS evaluates the body functionally in terms of strength in the sitting position. In addition, it evaluates the relationship between the body part and function by evaluating the body's static and dynamic balances and body coordination. It consists of three subsections: static, dynamic and coordination.
Change in dynamic and functional balance from baseline to week 8 to week 16. [baseline, 8th. week, 16th. week]
The dynamic and functional balances of the participants were evaluated with The Pediatric Balance Scale (PBS) before treatment, in the 8th week and the 16th week. PBS is an assessment tool adapted from the Berg Balance Scale (BDS) to evaluate children's functional balance in daily life activities. The scale consists of 14 sections and each section is scored between 0 and 4; the highest score that can be obtained from the scale is 56.
Change in dynamic balance in sitting and standing positions from baseline to week 8 to week 16 [baseline, 8th. week, 16th. week]
Pedalo® Sensamove Balance Test Pro (Holz-Hoerz Gesellschaft mit beschränkter Haftung (GmbH), Germany) Software with miniboard was used to evaluate the dynamic balance functions of the participants during their sitting, standing position at the beginning, at the 8th and at the 16th week. This device has been developed to record the movements of the user in order to learn about the balance, response time and possible imbalances of the body.
The Functional Independence Measure (WeeFIM) [baseline, 8th. week, 16th. week]
The functional independence of children in daily activities was assessed with The Functional Independence Measure (WeeFIM) initially, at week 8 and at week 16. WeeFIM consists of 6 parts: self-care, sphincter control, mobility, locomotion, communication, and social communication, and a total of 18 activities are questioned. It is scored from 1 to 7 according to whether it receives help, performs on time or whether an auxiliary device is required when performing the function in each item.
Change in walking functions from baseline to week 8 to week 16 [baseline, 8th. week, 16th. week]
Win-Track (Medicapteurs, France) path and software system was used to evaluate the walking functions (Spatio-temporal parameters) of participants at the beginning, in the 8th and the 16th week. Win-Track; static, posturography and gait analysis is a foot pressure-sensitive walking path that provides complete freedom in posture and movement acquisition. It records foot pressure up to 200 images per second during standing, walking or certain activities (such as sports movements, postural sequences) through 12.288 sensors on the Win-Track, which is in the form of a one-piece platform.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Having a diagnosis of Spastic Cerebral Palsy
Children aged between 5 - 18 years
GMFCS level is I, II or III
Independent seating
Walking with at least 10 meters of independent, orthotic and/or auxiliary device
Can understand simple verbal instruction
Those with hip adductor muscle spasticity level less than 2 according to MAS
Having bilateral passive hip abduction enough to could sit into the hippotherapy simulator device
Voluntarily agreed to participate in the study

Exclusion Criteria:

Those with hip dislocation
Severe contracture or deformity to prevent the study
Advanced scoliosis (above 20 degrees)
Acute uncontrolled acute seizures
Uncontrollable severe epileptic attacks
Visual and auditory problems
Injection of botulinum toxin in the last 6 months patients
Underwent surgical operation such as muscle relaxation, tendon extension, and selective dorsal rhizotomy in the last 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Özdel Dilbade Özel Eğitim ve Rehabilitasyon Merkezi	Istanbul		Turkey

Sponsors and Collaborators

Marmara University

Investigators

Principal Investigator: Canan GÜNAY YAZICI, PhD(c), Marmara University Institute of Health Sciences
Study Director: Zübeyir SARI, Assoc Prof, Marmara University Faculty of Health Sciences