- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05993598
The Effect of Hippotherapy Applied on Different Seating Surfaces in Children With Special Needs
August 8, 2023 updated by: Ebru Sever, Istanbul Medipol University Hospital
The Effect of Hippotherapy Applied on Different Sitting Surfaces on Sitting Balance and Walking Speed in Children With Special Needs
The effect of hippotherapy, which will be applied to children with special needs in a single session, on sitting balance and walking speed under the supervision of a physiotherapist was investigated.
30 randomly selected children with special needs between the ages of 3-18 who were referred to the Gebze Equestrian Training Center were included in the study.
The children were randomly divided into 3 groups: 10 in the saddle, 10 naked (direct contact with the horse), and 10 in the hippotherapy group, in which a cloth of different texture was placed on the horse.
Each group did a 30-minute hippotherapy session in the manege area.
Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game.
In addition, 10 m walking test was applied for walking speed.
These assessments were repeated after the 30-minute session.
It was checked whether the application had an effect on balance and walking speed.
Comparisons between the groups were made and it was examined which application was more effective on balance and walking speed.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gebze
-
Kocaeli, Gebze, Turkey, 41400
- Gebze Municipality Equestrian Training Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Having a child with special needs between the ages of 3-18,
- Children with a diagnosis of Cerebral Palsy (CP) have a level of 1 and 2 according to the Gross Motor Function Classification System,
- Ability to understand simple commands,
- Ability to sit unaided for at least 10 seconds,
Exclusion Criteria:
- Presence of clinical conditions that may pose an obstacle
- Lack of cooperation
- Presence in another study performed at the same time as the study
- Lack of family approval.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 (Saddled)
Each group did a 30-minute hippotherapy session in the manege area.
Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game.
In addition, 10 m walking test was applied for walking speed.
These assessments were repeated after the 30-minute session.
|
Evaluation parameters were applied to 30 children with special needs at the beginning of the session.
After the evaluation, each group was given a 30-minute hippotherapy session in the manege area.
During the practice, the child simply sat on the horse.
The horse was asked to maintain its balance by adapting to the oscillations it creates while walking on the sand.
Immediately after the 30-minute application, the initial evaluations were made again.
As a result, it was investigated whether hippotherapy applied on different sitting surfaces in children with special needs had an effect on sitting balance and walking speed.
|
Experimental: Group 2 (Saddleless, direct contact with horse)
Each group did a 30-minute hippotherapy session in the manege area.
Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game.
In addition, 10 m walking test was applied for walking speed.
These assessments were repeated after the 30-minute session.
|
Evaluation parameters were applied to 30 children with special needs at the beginning of the session.
After the evaluation, each group was given a 30-minute hippotherapy session in the manege area.
During the practice, the child simply sat on the horse.
The horse was asked to maintain its balance by adapting to the oscillations it creates while walking on the sand.
Immediately after the 30-minute application, the initial evaluations were made again.
As a result, it was investigated whether hippotherapy applied on different sitting surfaces in children with special needs had an effect on sitting balance and walking speed.
|
Experimental: Group 3 (Different tissue to be put on the saddle)
Bubbled nylon (pat-to-pat) was used as a different texture.
Each group did a 30-minute hippotherapy session in the manege area.
Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game.
In addition, 10 m walking test was applied for walking speed.
These assessments were repeated after the 30-minute session.
|
Evaluation parameters were applied to 30 children with special needs at the beginning of the session.
After the evaluation, each group was given a 30-minute hippotherapy session in the manege area.
During the practice, the child simply sat on the horse.
The horse was asked to maintain its balance by adapting to the oscillations it creates while walking on the sand.
Immediately after the 30-minute application, the initial evaluations were made again.
As a result, it was investigated whether hippotherapy applied on different sitting surfaces in children with special needs had an effect on sitting balance and walking speed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BeCure Balance Evaluation System
Time Frame: 11 weeks
|
BeCure Balance Assessment System protocol; It was planned to determine the amount of change in the center of gravity in the x and y axes and the position of the body center of gravity during balancing by sitting on the board for 30 seconds with eyes open, with images.
|
11 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ten(10) Meter Walking Test(sec)
Time Frame: 11 weeks
|
In this test, the person is asked to walk at their own normal pace in a pre-measured 10 meter area (if using walking aid, it will be done with it).
The time starts when the person's foot is on the starting line and ends when they cross the finish line.
Two measurements are made and the best value is recorded in meters per second (m/s).
|
11 weeks
|
Gross Motor Function Classification System (GMFCS)
Time Frame: 11 weeks
|
It was used to evaluate the motor functions of participants with a diagnosis of cerebral palsy.
It is a standardized method that classifies motor function differences in sitting and walking at 5 levels.
If we examine the 5 levels; Level I walks without restrictions; Level II walks with restrictions; Level III walks using hand-held mobility devices; Level IV, independent self-mobility is limited and may use a motorized mobility vehicle; Level V is transported in a manual wheelchair.
|
11 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ebru SEVER, Lecturer, Department of Physiotherapy & Rehabilitation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2023
Primary Completion (Actual)
February 17, 2023
Study Completion (Actual)
May 10, 2023
Study Registration Dates
First Submitted
July 31, 2023
First Submitted That Met QC Criteria
August 8, 2023
First Posted (Actual)
August 15, 2023
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 8, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- BURAKEMİRHAN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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