- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06502652
Hippotherapy Versus Balance Therapy on Funvtional Mobility in Down Syndrome
Effects of Hippo Therapy Versus Balance Training on Balance and Functional Mobility in Children With Down's Syndrome
Down Syndrome is a genetic condition caused by having an extra copy of chromosome 21 and 47 chromosomes instead of 46. A complete or partial extra copy of chromosome 21 is responsible for the anomaly and related structural and functional abnormalities of the body systems. Depending on the degree of abnormality, Down Syndrome has different impacts on different people as a result, differences exist in personality, abilities, talents, and physical and mental development. According to this syndrome the patients shared characteristics with one another that suggested they were siblings, including a broad, flat face, a small nose, a thick tongue, narrow palpebral fissures, obliquely positioned eyes, roundish and laterally extended cheeks, a long tongue, and varying degrees of intellectual impairment.
Prior to the study, all participants will be informed of the purpose and method of conducting the research. Each of them will sign an informed consent release to participate in the project and to process personal data for scientific purposes. This study aimed to determine the effects of hippo therapy versus balance training on balance and functional mobility in children with Down's Syndrome. Randomized clinical trials will be done. The study will be conducted in special school of education, Sargodha and Najeeb ullah rehabilitation centre, Sargodha in 10 months duration after approval of synopsis. Evaluation will be done by using pediatric balance scale, times up to go test, Functional independence measure for children, Tug test for functional mobility. Non-probability convenient sampling will be used and the subjects will be allocated to two groups by random allocation through lottery method; group A will be receiving hippo therapy and group B will be receiving balance training. Both groups will receive 8 sessions for the period of 4 weeks. Measurements of all the outcome variables will be taken at baseline, 2nd and 4th week. Data will be analyzed using SPSS-21.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
GROUP A:
Group A includes Hippo Therapy. A hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic. Child with down syndrome will be seated on the stimulator for 10-15 minutes every session. The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally
GROUP B Group B includes balance training. The therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill. Treadmill training completed under three conditions in 1-min training cycles. For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s. Each child repeated this procedure 20 Times and cool down for 5 minutes
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Riphah International University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age group of 6-14 years
- Both genders
Exclusion Criteria:
- Children with fixed deformity in LE
- Child with visual and hearing problems
- History of epilepsy
Study Plan
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 A includes Hippo Therapy.
A hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic.
Child with down syndrome will be seated on the stimulator for 10-15 minutes every session.
The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally
|
A hippotherapy simulator is a horse riding simulator exercise machine, mimicking a horse's gait and recreating the horseback riding experience within the safety of a therapy clinic.
Child with down syndrome will be seated on the stimulator for 10-15 minutes every session.
The patient's pelvis moves softly, rhythmically, and repetitively when riding this action is comparable to what the human pelvis does when walking normally
|
|
Active Comparator: balance training
The therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill.
Treadmill training completed under three conditions in 1-min training cycles.
For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s.
Each child repeated this procedure 20 Times and cool down for 5 minutes
|
The therapist modified the railing height to suit each child, ensuring the children were standing erect on the treadmill.
Treadmill training completed under three conditions in 1-min training cycles.
For 15 s of each minute the child could hold on to the railings with both hands, for the next 15 s with one hand, and finally with no hands on the handrails for 30 s.
Each child repeated this procedure 20 Times and cool down for 5 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PEDIATRIC BALANCE SCALE
Time Frame: 4 weeks
|
It is modified berg scale the 14 items on the scale are: standing balance, sitting balance, transfers, stepping, reaching forward with outstretched arm, reaching the floor, turning, and placing foot on stool
|
4 weeks
|
|
TIMES UP TO GO TEST
Time Frame: 4 weeks
|
The TUG was performed from a chair 40 cm high.
Participants were instructed to stand and walk 3 m to a designated area at a regular pace, then turn and return to the starting position, with the time to finish being recorded.
Each participant received two trials, with the best time noted.
|
4 weeks
|
|
FUNCTIONAL INDEPENDENCE MEASURE
Time Frame: 4 weeks
|
The maximum score on each of the 18 elements in the FIM is 7, the minimum score is 1, and the maximum possible score is 126 points.
The 18 items in the FIM can be split down into two categories: five items for assessing cognitive ADL (which includes two items for communication and three items for social cognition) and thirteen items for testing motor ADL
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: faiza khalid, MS, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- REC/RCR&AHS/23/0797
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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