- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06550258
Effects of Hippotherapy on Functionality in Children With Cerebral Palsy
Effects of Hippotherapy on Upper Extremity Functionality and Trunk Control in Children With Cerebral Palsy
The purpose of this clinical review is to investigate the effect of hippotherapy in improving upper limb functionality in children with cerebral palsy. The main question it aims to answer is The questions are as follows:
- Does hippotherapy improve gross motor function of the upper extremity in children with cerebral palsy?
- Is the development of trunk control in children with cerebral palsy who receive hippotherapy different from the development of trunk control in children who receive conventional physiotherapy?
Participants will:
Hippotherapy and routine physiotherapy in 2 different groups for 2 They will carry out the necessary evaluations before the implementation and at the end of 2 months.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tuba Kolaylı, Mac.
- Phone Number: (216) 400 22 22
- Email: tuba.kolayli@uskudar.edu.tr
Study Locations
-
-
Ümraniye
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İstanbul, Ümraniye, Turkey, 34768
- Recruiting
- Uskudar University
-
Contact:
- Tuba Kolaylı, MSc.
- Email: tuba.kolayli@uskudar.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having been diagnosed with SP
- Being between the ages of 4-16
- Being at GMFCS (Gross Motor Function Classification System) level 1,2 or 3
- Being at MACS (The Manual Ability Classification System) level 1,2,3 or 4
- Having a stable clinical condition
- Having the cognitive level to follow the instructions in the test and treatment protocol
Exclusion Criteria:
- Families who do not sign the consent form
- Presence of active seizures
- Presence of developmental hip dysplasia
- Presence of allergy to horses
- Having undergone surgical intervention or Botulinum Toxin A (BTX-A) application in the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hippotherapy group
Hippotherapy was applied with a physiotherapist for 2 months.
|
Hippotherapy is a therapeutic intervention applied by physiotherapists that aims to improve impaired body functions.
Hippotherapy is a therapy in which the rider receives stimuli from the horse that stimulate the sensory, neuromotor and cognitive systems during riding and exercise on the back of a horse.
Hippotherapy is effective on posture control, balance, gross motor functions and functional performance in children with cerebral palsy.
|
|
Active Comparator: Control group
Classical physiotherapy was applied with the help of a physiotherapist for 2 months.
|
In traditional pediatric physiotherapy, cushions of appropriate hardness were used for proprioceptive input.
Stools of different heights were used for sitting, squatting, standing up by holding on and standing, Bobath balls and balance boards were used for balance reactions.
Triangular and roll cushions of different hardness were used for weight transfer.
Surfaces with different patterns were used for sensory input.
The child's wishes and interests were taken into consideration in the selection of materials.
The treatment was planned according to the activities that were difficult in daily life and the aim was to transfer the knowledge learned to daily life.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Box and block test
Time Frame: 8 weeks
|
This test evaluates manual dexterity.
The person being tested is asked to move blocks from one compartment to the other compartment as fast as they can within 60 seconds.
The test is started with the dominant hand and the test is repeated with both hands.
In addition, a 15-second trial period is given for both hands.
The blocks are held in the compartment on the side of the hand to be tested, and the test is started by positioning the box in the midline of the person being tested.
When the time is up, the blocks carried are counted and the result is recorded.
|
8 weeks
|
|
Trunk Control Measurement Scale
Time Frame: 8 weeks
|
The Trunk Control Measurement Scale includes 15 items that measure the two main components of trunk control, static and dynamic sitting balance.
The Static Sitting Balance Scale (items 1-5) evaluates the ability to maintain stable trunk posture during movements of the upper and lower extremities.
The Dynamic Sitting Balance Scale (items 6-15) is divided into two subscales: the selective movement control scale and the dynamic reach scale.
The total score ranges from 0-58.
A high score indicates good performance.
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8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ABILHAND-Kids
Time Frame: 8 weeks
|
It is used to measure hand functions in children with CP.
It aims to measure the use of the upper extremity in children's daily activities in 21 items (It is examined in 3 columns as cannot be done, difficult, easy.
It mostly evaluates the function of both hands together.
The scale is generally applied by asking the families, if the child is older, he/she can be included in the application.
There should be no assistive device or human support while evaluating the functional ability.
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8 weeks
|
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Moberg pickup test
Time Frame: 8 weeks
|
In a performance-based (timed) manual dexterity test, the patient is asked to fill certain items into a box.
The test is started with the dominant hand, then with the non-dominant hand and with eyes closed.
The test is repeated 3 times and the best time on the stopwatch is noted.
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8 weeks
|
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Gross Motor Function Measure
Time Frame: 8 weeks
|
GMFM-88 is a scale developed for children with CP to show changes in gross motor functions.
It is divided into 5 main sections as lying-rolling, sitting, crawling-kneeling, standing, walking-running-jumping.
The values are divided into 4 categories as -Cannot initiate the activity ''0'', -Initiates independently ''1'', -Partially completes ''2'', -Completes independently ''3''.
The total score is calculated as a percentage, as the percentage values increase, motor functions increase.
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8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Champagne D, Corriveau H, Dugas C. Effect of Hippotherapy on Motor Proficiency and Function in Children with Cerebral Palsy Who Walk. Phys Occup Ther Pediatr. 2017 Feb;37(1):51-63. doi: 10.3109/01942638.2015.1129386. Epub 2016 Mar 1.
- Park ES, Rha DW, Shin JS, Kim S, Jung S. Effects of hippotherapy on gross motor function and functional performance of children with cerebral palsy. Yonsei Med J. 2014 Nov;55(6):1736-42. doi: 10.3349/ymj.2014.55.6.1736.
- Kwon JY, Chang HJ, Yi SH, Lee JY, Shin HY, Kim YH. Effect of hippotherapy on gross motor function in children with cerebral palsy: a randomized controlled trial. J Altern Complement Med. 2015 Jan;21(1):15-21. doi: 10.1089/acm.2014.0021. Epub 2014 Dec 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 61351342/2019-399
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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