Investigation of the Effect of Hippotherapy Simulator in Children With Spastic Diplegia and Cerebral Palsy

Sponsor

Uskudar University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06003868

Collaborator

(none)

Enrollment

Location

Arms

4.5

Anticipated Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to examine the effect of hippotherapy simulator on trunk control, balance and gait in children with spastic diplegia cerebral palsy and its relationship with quality of life.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy Balance; Distorted Walking, Difficulty	Other: traditional physiotherapy Other: hippotherapy-assisted physiotherapy	N/A

Detailed Description

Patients diagnosed with spastic diplegia cerebral palsy in the study; It will be classified according to Gross Motor Function Classification System (KMFSS). The Trunk Control Measurement Scale will be used to assess trunk control. Pediatric Berg Balance Scale will be used to assess balance. The 1 Minute Walk Test and the Timed Get Up and Go test will be used to assess walking. The WEEFIM scale will be used to assess quality of life. The study sample will be divided into two groups. The first group will receive 45 minutes of conventional physical therapy. In addition to 45 minutes of physical therapy, the other group will receive 15 minutes of hippotherapy simulator. The results will be compared at the beginning and end of the study.

Then, individuals will be divided into two groups with a simple randomized method. Traditional physical therapy will be applied to the control group for 45 minutes, 2 days a week, for 8 weeks. In addition to traditional physical therapy, 15 minutes of therapy training with a hippotherapy device will be applied to the experimental group. Evaluation tests will be repeated at the beginning and end of the study. Pre- and post-intervention data were statistically analyzed and compared.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Exercises with Hippotherapy Simulator: This exercise will be applied to the group for 8 weeks, 2 days a week, as a single session (15 minutes) a day. The patients will be placed on the simulator and the starting position will be taught. They will be warned to maintain the starting position throughout the movements of the simulator. The hippotherapy simulator will be operated almost in the gait pattern of the horse and in the 1st stage of the 3-stage speed level. If the patients have unusual complaints such as dizziness, blackout, chest pain and risk of falling during the application. they will be advised to request to stop the applicationExercises with Hippotherapy Simulator: This exercise will be applied to the group for 8 weeks, 2 days a week, as a single session (15 minutes) a day. The patients will be placed on the simulator and the starting position will be taught. They will be warned to maintain the starting position throughout the movements of the simulator. The hippotherapy simulator will be operated almost in the gait pattern of the horse and in the 1st stage of the 3-stage speed level. If the patients have unusual complaints such as dizziness, blackout, chest pain and risk of falling during the application. they will be advised to request to stop the application

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Investigation of the Effect of Hippotherapy Simulator on Balance and Walking in Children With Spastic Diplegia Cerebral Palsy

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jan 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group Physiotherapy will be applied for 8 weeks, 2 days a week, as one session per day (45 minutes).	Other: traditional physiotherapy Stretching for patients with spasticity exercises walking exercises for balance and gait disorders muscle strengthening exercises relaxation exercises
Experimental: hippotherapy group Physiotherapy will be applied for 8 weeks, 2 days a week, one session a day (45 minutes). In addition, the patients will be placed on the simulator and the starting position will be taught. your simulator They will be warned before and during the application to maintain the starting position throughout their movements. pattern and will be run in the 1st stage of the 3-stage speed level.	Other: traditional physiotherapy Stretching for patients with spasticity exercises walking exercises for balance and gait disorders muscle strengthening exercises relaxation exercises Other: hippotherapy-assisted physiotherapy The patients will be placed on the simulator and the starting position will be taught. your simulator before the application and in order to maintain the starting position throughout their movements. they will be warned during the applications.. Hippotherapy simulator is almost like walking. pattern and will be run in the 1st stage of the 3-stage speed level.

Arm

Intervention/Treatment

Active Comparator: control group

Physiotherapy will be applied for 8 weeks, 2 days a week, as one session per day (45 minutes).

Other: traditional physiotherapy

Stretching for patients with spasticity exercises walking exercises for balance and gait disorders muscle strengthening exercises relaxation exercises

Experimental: hippotherapy group

Physiotherapy will be applied for 8 weeks, 2 days a week, one session a day (45 minutes). In addition, the patients will be placed on the simulator and the starting position will be taught. your simulator They will be warned before and during the application to maintain the starting position throughout their movements. pattern and will be run in the 1st stage of the 3-stage speed level.

Other: traditional physiotherapy

Stretching for patients with spasticity exercises walking exercises for balance and gait disorders muscle strengthening exercises relaxation exercises

Other: hippotherapy-assisted physiotherapy

The patients will be placed on the simulator and the starting position will be taught. your simulator before the application and in order to maintain the starting position throughout their movements. they will be warned during the applications.. Hippotherapy simulator is almost like walking. pattern and will be run in the 1st stage of the 3-stage speed level.

Outcome Measures

Primary Outcome Measures

Pediatric Berg Balance Scale [10 weeks]
Berg Balance Scale was designed for children to evaluate functions in activities of daily living. version. The scale consists of 14 assessments and each section is scored between 0-4; The highest possible score is 56.
Trunk Control Measurement Scale [10 weeks]
For this reason, the scale consists of two parts: Static Sitting Balance (SSB) and Dynamic Sitting Balance (DSB). The DSB section also consists of two sub-parameters as selective motion control and dynamic reach. While the static sitting balance subscale evaluates static trunk control during lower and upper extremity movements, the selective motion control subscale evaluates selective trunk movements in three planes (flexion/extension, rotation, and lateral flexion). The dynamic reach subscale evaluates performance during reaching tasks that require active trunk movement. The scale consists of 15 items in total (subscales 5, 7 and 3 items, respectively). Items are scored on a 2, 3, and 4-point ordinal scale and are administered bilaterally when clinically significant. While the total score of the scale varies between 0-58 points, higher scores indicate a better performance.
1 Minute Walk Test [10 weeks]
First, the child puts on his own clothes and shoes. He is allowed to use his splints and suitable walking aid. At least 5 minutes before starting the test. He is allowed to rest and then brought to the starting point of the path he will walk. When the command is given, it is said to start walking as fast as possible for 1 minute. It is also reported that he is not allowed to run. The distance is then calculated.
Timed get up and go test [10 weeks]
It is a test used to measure mobility and assesses walking speed, postural control, functional mobility and balance. The Timed Get Up and Go Test measures the time it takes for a person to get up from an arm-supported chair, turn by walking 3 m, and walk back to the chair, then sit down. The time it takes to get up from the chair and sit back on the chair is recorded.
Functional independence measurement for children (WEEFIM) [10 weeks]
It was developed to assess the level of functional independence of children with a physical disability and consists of three main categories and a total of 18 questions. A total of 18 questions under the heading of self-care, mobility and cognitive function categories are scored between 1 and 7. According to this; While performing the function to be evaluated, the child with a physical disability gets 1 point if he/she does it completely with assistance, and 7 points if he/she does it completely independently. The lowest score that the child can get from the scale is 18, and the highest score is 126.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diplegic Cerebral Palsy between the ages of 4 and 16
Levels 1,2 and 3 according to KMFSS
Have not had botox or surgery in the last 6 months
Able to perceive simple commands
Patients who can sit in the hippotherapy simulator will be included.

Exclusion Criteria:

With hip dislocation
Those with hearing or visual disabilities
Those who do not want to be involved in the study
Adductor spasticity is stage 3 and above according to the ashworth spasticity scale.
With upper extremity amputation