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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06131099
Other study ID # REC/RCR&AHS/23/0762
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2023
Est. completion date February 28, 2024

Study information

Verified date December 2023
Source Riphah International University
Contact Imran Amjad, PhD
Phone +923324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This study will be a randomized control trial, used to compare the effects of Dohsa hou exercises on functional mobility in children with Down syndrome. Subjects with Down syndrome meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling techniques. Assessment will be done by using Test of trunk impairment scale and Time Up and Go Test. Subjects in one group will be treated with Dohsa hou therapy and in other group standard treatment protocol.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date February 28, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: 1. Down syndrome 2. Age group of 6 to 12 years old 3. Male and female (both genders) 4. Body mass index (BMI) within normal range <95% 5. Absence of any psychiatric and physical illness at the time of participation. Exclusion Criteria: 1. Uncontrolled seizures 2. Any kind of autoimmune diseases 3. Registered visually impaired or hearing issues 4. Severe atlanto axial instability 5. Congenital heart defects (CHD) 6. Unable or unwilling to understand the commands

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dohsa hou exercises
Dohsa hou is a type of psychomotor therapy that helps improve psychological problems by using bodily movements, sensation and relaxation experience.
Standard treatment protocal
Standard treatment including soft tissue massage therapy, task specific training interventions, bicycle training and aerobic exercises.

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Fujino H, Moritsugu A. Dohsa-hou for unexplained regression in Down syndrome in a 19-year-old man: A case report. Clin Case Rep. 2022 May 15;10(5):e05827. doi: 10.1002/ccr3.5827. eCollection 2022 May. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Trunk impairment scale 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. 6 weeks
Primary Time up and go 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
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