- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06131099
Effects of Dohsa Hou Exercises on Functional Mobility
Effects of Dohsa Hou Exercises on Functional Mobility in Children With Down Syndrome
Trisomy 21 is a condition where there's an extra chromosome 21, which leads to a set of clinical signs called Down syndrome. Down syndrome is one of the most complicated genetic conditions that can occur post-term and is the most commonly survivable form of aneuploidy of the autosomal chromosomes.
Dohsa hou is a type of psychomotor therapy that helps improve psychological problems by using bodily movements, sensation and relaxation experience. It was first developed under the name psycho-rehabilitation to help children with cerebral palsy improve their movements and posture. By using Dohsa hou movement's issues were effectively addressed in children with cerebral palsy, despite their physical limitations being caused by physiological disorders. There are two kind of treatments of Dohsa hou exercises that are relaxation therapy to decrease the stress level in body and other one is to align the body to correct the posture and movements of the body.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Riphah International University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Down syndrome
- Age group of 6 to 12 years old
- Male and female (both genders)
- Body mass index (BMI) within normal range <95%
- Absence of any psychiatric and physical illness at the time of participation.
Exclusion Criteria:
- Uncontrolled seizures
- Any kind of autoimmune diseases
- Registered visually impaired or hearing issues
- Severe atlanto axial instability
- Congenital heart defects (CHD)
- Unable or unwilling to understand the commands
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 |
|---|---|
|
Active Comparator: Group A
In this group patient will be treated with standard treatment protocol.
This group will receive therapy session for 1 hour, three sessions in a week and for 6 weeks, total sessions will be 18.
Group A will receive soft tissue massage therapy for 5 mins and the task specific training interventions include bicycle training for 10 mins.
After that aerobic exercises includes and finally some of progressive resistive exercises will involve in it.
|
Standard treatment including soft tissue massage therapy, task specific training interventions, bicycle training and aerobic exercises.
|
|
Active Comparator: Group B
In this group patient will be treated with Dohsa hou exercises.
This group will receive therapy session for 1 hour, three sessions in a week and for 6 weeks, total sessions will be 18.
Group B will receive Dohsa hou exercises, session will be included three activity parts: (a) 10 minutes of instruction and preparation, (b) 45 minutes of skill instruction and practice, and (c) 5 minutes in a closing activity.
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Dohsa hou is a type of psychomotor therapy that helps improve psychological problems by using bodily movements, sensation and relaxation experience.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk impairment scale
Time Frame: 6 weeks
|
The trunk impairment scale will be used for this study to identify the balance and coordination in sitting and standing state.
The assessment tool uses a 2 to 4 point ranking system for each item.
The highest possible scores for the static and dynamic sitting balance and coordination scales are 7, 10 and 6 points.
The TSI score can range from 0 to 23, with a score of 0 indicating minimal performance and a perfect score of 23.
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6 weeks
|
|
Time up and go
Time Frame: 6 weeks
|
Time up and go test will be used to assess the balance and stability of a children with different abilities. It involves timing how long it takes for a child to stand up from a chair, walk a short distance, turn around, walk back, and sit down while turning 180 degree. Interpretation: < 10 seconds = normal, < 20 seconds = good mobility, can go out alone, mobile without a gait aid. < 30 seconds = problems, cannot go outside alone, requires a gait aid. A score of more than or equal to fourteen seconds has been shown to indicate high risk of falls. |
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Asif Javed, 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0762
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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