- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06554171
Hippotherapy Simulators on Trunk Control and Upper Extremity Functions in Cerebral Palsy
August 13, 2024 updated by: Songül Bağlan Yentür, Firat University
Investigation of the Effect of Hippotherapy Simulators on Trunk Control and Upper Extremity Functions in Children With Cerebral Palsy
The hippotherapy simulator imitates the three-dimensional mechanical movement and walking of the horse and transfers the mechanical effect to the rider during hippotherapy.
The aim of this study was to investigate the effect of exercise program with hippotherapy simulator on upper extremity functions and trunk control of individuals with cerebral palsy.All individuals diagnosed with Cerebral Palsy who agree to participate in the study and meet the inclusion criteria will be randomly divided into two groups as Study and Control Group.
In addition to conventional physiotherapy, the study group will be trained in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.n
addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.
However, the simulator will be kept in closed position to prevent oscillations.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Cerebral Palsy can be defined as a non-progressive lesion that occurs in the brain that has not yet completed its development and causes activity limitation with movement and posture problems.
Although the disorders seen in Cerebral Palsy are not progressive, these individuals may experience losses in their current motor functions in later ages and this may cause losses in their independence and activities of daily living.
The hippotherapy simulator imitates the three-dimensional mechanical movement and walking of the horse and transfers the mechanical effect to the rider during hippotherapy.
The aim of this study was to investigate the effect of exercise program with hippotherapy simulator on upper extremity functions and trunk control of individuals with cerebral palsy.All individuals diagnosed with Cerebral Palsy who agree to participate in the study and meet the inclusion criteria will be randomly divided into two groups as Study and Control Group.
In addition to conventional physiotherapy, the study group will be trained in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.n
addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.
However, the simulator will be kept in closed position to prevent oscillations.
Study Type
Interventional
Enrollment (Estimated)
20
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
-
-
-
Elazığ, Turkey, 23100
- Recruiting
- Songul Baglan Yentur
-
Contact:
- Songul Baglan Yentur
- Phone Number: 04242370000
- Email: songulbaglan23@hotmail.com
-
Contact:
- Songul Baglan Yentur
- Phone Number: 8282 +904242370000
- Email: songulbaglan23@hotmail.com
-
-
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:
- Being between 6-18 years old
- Being diagnosed with unilateral spastic type cerebral palsy
- Voluntariness of the family and individuals to participate in the study
- Being at I, II, III level according to the Hand Skills Classification System
- To have the cognitive development to cooperate
Exclusion Criteria:
- Having undergone any orthopedic and/or neurological surgery and/or BoNT A operation within the last 6 months
- Having a history of epilepsy
- Hearing and/or vision loss at a level that prevents participation in the study
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: Hippotherapy group
In addition to conventional physiotherapy, training will be given in the Hippotherapy Simulator for 15 minutes a day, 5 days a week for 4 weeks.
The hippotherapy simulator serves a wide range of purposes from recreational use that mimics the movements of a real horse or can make similar movements, to fitness, exercise, sports, education and therapy and is suitable for use by individuals with cerebral palsy.
|
In addition to conventional physiotherapy, training will be given in the Hippotherapy Simulator for 15 minutes a day, 5 days a week for 4 weeks.
The hippotherapy simulator serves a wide range of purposes from recreational use that mimics the movements of a real horse or can make similar movements, to fitness, exercise, sports, education and therapy and is suitable for use by individuals with cerebral palsy.
|
|
Experimental: Control group
In addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.
However, the simulator will be kept in closed position to prevent oscillations.
|
In addition to conventional physiotherapy, the control group will be allowed to sit in the Hippotherapy Simulature for 15 minutes a day, 5 days a week for 4 weeks.
However, the simulator will be kept in closed position to prevent oscillations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Function assessment
Time Frame: 2 minutes
|
Jabson Taylor hand function test will be used.
The test measures the accuracy of speed and performance on a variety of grip and release tasks using everyday items.
|
2 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk control assessment
Time Frame: 2 minutes
|
The Trunk Control Measurement Scale (TCMS) will be used to assess trunk control in the participants.
The fifteen-item SCS assesses static and dynamic components of the trunk during sitting.
|
2 minutes
|
|
Balance assessment
Time Frame: 2 minutes
|
Timed up and go test will be used to evaluate balance.
The patient is asked to stand up from the chair without support from the chair, walk 3 m, walk back towards the chair without touching anything and take the sitting position again.
The time starts when the patient stands up from the chair and ends when the patient returns to the chair and sits down again.
|
2 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
August 20, 2024
Primary Completion (Estimated)
October 20, 2024
Study Completion (Estimated)
October 30, 2024
Study Registration Dates
First Submitted
August 13, 2024
First Submitted That Met QC Criteria
August 13, 2024
First Posted (Actual)
August 15, 2024
Study Record Updates
Last Update Posted (Actual)
August 15, 2024
Last Update Submitted That Met QC Criteria
August 13, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/10-03
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.