- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06943508
Nordic Walk on Balance and Functional Strength in Children With Down Syndrome
Effects of Nordic Walk on Balance and Functional Strength in Children With Down Syndrome
Down syndrome (DS) is one of the more commonly occurring genetic disorders, where mental retardation is combined with nutritional diseases. It is caused by having a third copy of chromosome 21, and there exist 3 forms; Simple Trisomy 21, Translocation Trisomy and Mosaic Trisomy. It is coupled with mental retardation, congenital heart defects, gastrointestinal anomalies .Nordic walking exerts beneficial effects on resting heart rate, blood pressure, exercise capacity, maximal oxygen consumption, and quality of life in patients with various diseases and can thus be recommended to a wide range of people as primary and secondary prevention.
This study will aim to examine the effects of Nordic walk on balance and functional strength in children with Down syndrome. A Randomized Controlled Trial will be conducted through convenient sampling 32 subjects will randomly be allocated into two groups. Group A will include 16 children and will receive conventional exercise program.
Group B will include 16 children and will receive Nordic walking program. Each session will be 30 minutes, 5 sessions per week. The total duration of the study will be 6 weeks.
Pediatric berg balance scale and modified time up and go test, and functional strength test will be used as outcome measure Data will be analyzed on SPSS version 29.0, normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Down syndrome (DS) is one of the more commonly occurring genetic disorders, where mental retardation is combined with nutritional diseases. It is caused by having a third copy of chromosome 21, and there exist 3 forms; Simple Trisomy 21, Translocation Trisomy and Mosaic Trisomy. It is coupled with mental retardation, congenital heart defects, gastrointestinal anomalies, weak neuromuscular tone, dysmorphic features of the head, neck and airways, audio vestibular and visual impairment, characteristic facial and physical features, hematopoietic disorders and a higher incidence of other medical disorders. Children with Down's syndrome (DS) often have greater postural sway and delay in motor development. Muscle weakness and hypotonia, particularly of the lower extremities, are theorized to impair their overall physical health and ability to perform daily activities. Nordic walking exerts beneficial effects on resting heart rate, blood pressure, exercise capacity, maximal oxygen consumption, and quality of life in patients with various diseases and can thus be recommended to a wide range of people as primary and secondary prevention. This study will aim to examine the effects of Nordic walk on balance and functional strength in children with Down syndrome. A Randomized Controlled Trial will be conducted through convenient sampling 32 subjects will randomly be allocated into two groups. Group A will include 16 children and will receive conventional exercise program.
Group B will include 16 children and will receive Nordic walking program. Each session will be 30 minutes, 5 sessions per week. The total duration of the study will be 6 weeks.
Pediatric berg balance scale and modified time up and go test, and functional strength test will be used as outcome measure Data will be analyzed on SPSS version 29.0, normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54900
- Recruiting
- Riphah International University
-
Contact:
- IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
-
Contact:
- Muhammad Asif Javed, MS PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children with age group of 8-13
- Both male and female
- Functional ability sufficient enough to understand commands, direction and exercise guidance
- Have ability to walk 60 meters independently according to 6- minute walk test
- Children who can stand and walk with balance problem as revealed from physical examination having 20 to 42 scores on PBS.
Exclusion Criteria:
Uncontrolled seizures
- Any kind of orthopedic condition
- Registered visually impaired
- Atlanto Axial instability
- Any chest infection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
Control: Conventional therapy program for 30 min , 5 days per week during 6 week period
|
Conventional Therapy group: Group A will be control group which will recieve conventional physical therapy program like curl up, lateral step up and sit to stand for 6 weeks( 5 sessions per week)
|
|
Experimental: Group B
Experimental: Nordic Walk for 30 min, 5 days per week during 6 week period
|
Nordic Walk group: Group B will recieve Nordic walking for 6 weeks ( 5 sessions per week)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric berg balance scale
Time Frame: Baseline, 6th week
|
Pediatric balance scale is a modified version of berg balance scale that is used to assess functional balance skills in children.
The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum NORDIC WALK ON BALANCE AND FUNCTIONAL STRENGHT IN CHILDERN WITH DOWN SYNDROME 11 score of 56 points It has good reliability and validity with (ICC=0.997)
(r=0.797,
p <0.05)
|
Baseline, 6th week
|
|
Timed UP & GO (TUG) test
Time Frame: Baseline, 6th week
|
The timed UP & GO (TUG) test was developed by Podsiadlo and Richardson in 1991 that is used to assess dynamic balance during the performance of a task.
This test measures in second the time required for an individual to stand up from a standard chair with armrest, walk 3m and turn around with reliability and validity of (ICC=0.98;
p<0.01)
|
Baseline, 6th week
|
|
Functional Strength Test
Time Frame: Baseline, 6th week
|
To assess functional performance in children with functional exercises in which the large muscle group that are important for standing and walking are being tested.
Three closed kinetic chain exercises were chosen.
Subjects were instructed to perform as many repetitions as possible in 30 seconds.
ICC value ranged from 0.91 to 0.96
|
Baseline, 6th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Namra Khalid, MS-PPT, Study Principal Investigator
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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/namra khalid
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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