- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07244133
Effects of Powerball in Children With Down Syndrome
Comparative Effects Of Powerball Using Static and Dynamic Surface on Upper Limb Endurance and Coordination in Children With Down Syndrome
This randomised clinical trial investigates the effects of powerball using static and dynamic surface on upper limb Endurance and coordination in children with Down Syndrome. The study involves 28 children with Down Syndrome aged 6-10 years, will be randomly assigned one of the two groups for 3 week intervention period.
Power ball training 3 sessions per week with the duration of 30 mins each session. Group A will receive different upper extremity activities with power ball on static surface while Group B will receive same activities with power ball on dynamic surface using a BOSU ball. The whole session followed by warm up and cool down sessions for 5 minutes each. Endurance will be assessed through ABIL-HAND kids tool. To access the coordination BOT-2 subsets test will be used.
Data will be assessed using SPSS 27.0.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This Randomized Clinical Trial (RCT) investigates the Comparative Effects of Powerball using static and dynamic surface on Upper Limb Endurance and Coordination in Children with Down Syndrome.This programme was designed to enhance the coordination and endurance in children with Down Syndrome.The efficacy of this programme was investigated through RCT. Data will be collected from special schools or rehabilitation centers. Data will be conducted on 28 children aged 6-10 years,diagnosed with Down Syndrome with reduced upper extremity endurance and coordination..
After screening participants will undergo 3 weeks power ball endurance training session, consisting of structured, repetitive and goal directed activities. Power ball training 3 sessions per week with the duration of 30 mins each session. Group A will receive different upper extremity activities with power ball on static surface while Group B will receive same activities with power ball on dynamic surface using a BOSU ball. The whole session followed by warm up and cool down sessions for 5 minutes each. Endurance will be assessed through ABIL-HAND kids tool. To access the coordination BOT-2 subsets test will be used.
Data will be assessed using SPSS 27.0.
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, MSPT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 5400
- Recruiting
- Imran Amjad
-
Contact:
- Muhmmad Asif Javed, MS
- Phone Number: 033224209422
- Email: a.javed@ripah.edu.pk
-
Contact:
- Aymun Javed, MS*
- Phone Number: 03216423117
- Email: aymunbutt02@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children with Down Syndrome
- Aged between 6-10 years
- Both Genders
- Ability to follow commands and instructions
Exclusion Criteria:
- Children with any orthopedic and neurological conditions associated with the syndrome • Children with any other Genetic disorder.
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 |
|---|---|
|
Experimental: The intervention will be power ball exercises on static surface
Participants will undergo 3 weeks power ball endurance training session, consisting of structured, repetitive and goal directed activities. Power ball training 3 sessions per week with the duration of 30 mins each session. Group A will receive different upper extremity activities with power ball on static surface.The whole session followed by warm up and cool down sessions for 5 minutes each.Endurance will be assessed through ABIL-HAND kids tool. To access the coordination BOT-2 subsets test will be used. Data will be assessed using SPSS 27.0. |
Participants will undergo 3 weeks power ball endurance training session, consisting of structured, repetitive and goal directed activities.
Power ball training 3 sessions per week with the duration of 30 mins each session.
Group A will receive different upper extremity activities with power ball on static surface.
The whole session followed by warm up and cool down sessions for 5 minutes each.
|
|
Experimental: The intervention will be powerball exercises on dynamic surface
Participants will undergo 3 weeks power ball endurance training session, consisting of structured, repetitive and goal directed activities. Power ball training 3 sessions per week with the duration of 30 mins each session. Group B will receive different upper extremity activities with power ball on dynamic surface.The whole session followed by warm up and cool down sessions for 5 minutes each. Endurance will be assessed through ABIL-HAND kids tool. To access the coordination BOT-2 subsets test will be used. Data will be assessed using SPSS 27.0. |
Participants will undergo 3 weeks power ball endurance training session, consisting of structured, repetitive and goal directed activities.
Power ball training 3 sessions per week with the duration of 30 mins each session.Group B will receive same activities with power ball on dynamic surface using a BOSU ball.
The whole session followed by warm up and cool down sessions for 5 minutes each.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ABIL-HAND
Time Frame: Baseline- 1st week and 3rd week
|
ABIL-HAND Kids Tool is used for the assessment of upper extremity endurance.
It's a parent-reported measure of a child's manual ability (unilateral and bilateral hand use) in everyday tasks.
Parents rate each of 21 activities as Impossible / Difficult / Easy.
The item difficulty increases with bimanual involvement.
The responses are expressed in form of logits.
0.90 is the reliability with a validity of 0.77
|
Baseline- 1st week and 3rd week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BOT-2
Time Frame: Baseline- 1st week and 3rd week
|
BOT-2 is a tool used for upper extremity coordination.
This test is used to measures control and coordination of arm and hand movements.
In this test visual and manual motor coordination (e.g., jumping, catching, throwing) will be assessed by performing different activities.
The reliability of this tool is 0.86
|
Baseline- 1st week and 3rd week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: AYMUN JAVED, MSPT, Ripha International University
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/Aymun Javed
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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