Down SyndromeNCT07244133
Effects of Powerball in Children With Down Syndrome
A study testing Power ball with static surface and Powerball with dynamic surface in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Power ball with static surface and Powerball with dynamic surface
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Oct 2025to 16 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with Down Syndrome
- Aged between 6-10 years
- Both Genders
- Ability to follow commands and instructions
Who cannot join
- Children with any orthopedic and neurological conditions associated with the syndrome • Children with any other Genetic disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Imran Amjad
Lahore, Punjab Province, 5400
Muhmmad Asif Javed, MS, 033224209422, a.javed@ripah.edu.pk
Aymun Javed, MS*, 03216423117, aymunbutt02@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Power ball with static surface, Powerball with dynamic surface
- Keywords
- Down Syndrome (DS), Powerball,, Upper extremity, Children
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power ball with static surfaceOther
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.
Powerball with dynamic surfaceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The intervention will be power ball exercises on static surface | Experimental | 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. Receives: Other: Power ball with static surface |
| The intervention will be powerball exercises on dynamic surface | Experimental | 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. Receives: Other: Powerball with dynamic surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
ABIL-HAND
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
Measured: Baseline- 1st week and 3rd week
Secondary outcomes (1)
BOT-2
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
Measured: Baseline- 1st week and 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start22 Oct 2025
- Primary completion2 Jun 2026 (estimated)
- Study completion16 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial (RCT) 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AYMUN JAVED, MSPT, Principal investigator, Ripha International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244133
- Sponsor's protocol ID
- REC/RCR&AHS/Aymun Javed
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blazquez-Fernandez A, Lopez-Hazas-Jimenez G, Fernandez-Vazquez D, Navarro-Lopez V, Fernandez-Gonzalez P, Marcos-Anton S, Molina-Rueda F, Cano-de-la-Cuerda R. Effects of the powerball(R) system on muscle strength, coordination, fatigue, functionality and quality of life in people with multiple sclerosis. A randomized clinical trial. J Neuroeng Rehabil. 2024 Mar 2;21(1):33. doi: 10.1186/s12984-024-01325-w.
PubMed 38431591
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects Of Powerball Using Static and Dynamic Surface on Upper Limb Endurance and Coordination in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07244133
- Acronym / sponsor ID
- REC/RCR&AHS/Aymun Javed
- Conditions
- Down Syndrome
- Keywords
- Down Syndrome (DS), Powerball,, Upper extremity, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 2 Jun 2026 (estimated)
- Study completion
- 16 Jun 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial (RCT) 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.
| Arm | Type | Receives |
|---|---|---|
| The intervention will be power ball exercises on static surface | Experimental | Other: Power ball with static surfaceParticipants 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. |
| The intervention will be powerball exercises on dynamic surface | Experimental | Other: Powerball with dynamic surfaceParticipants 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with Down Syndrome
Key exclusion criteria (1 listed)
- Children with any orthopedic and neurological conditions associated with the syndrome • Children with any other Genetic disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power ball with static surfaceParticipants 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. | Other | The intervention will be power ball exercises on static surface |
| Powerball with dynamic surfaceParticipants 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. | Other | The intervention will be powerball exercises on dynamic surface |
Primary outcome
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
1 secondary outcome
BOT-2
Time frame: Baseline- 1st week and 3rd week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 38431591Blazquez-Fernandez A, Lopez-Hazas-Jimenez G, Fernandez-Vazquez D, Navarro-Lopez V, Fernandez-Gonzalez P, Marcos-Anton S, Molina-Rueda F, Cano-de-la-Cuerda R. Effects of the powerball(R) system on muscle strength, coordination, fatigue, functionality and quality of life in people with multiple sclerosis. A randomized clinical trial. J Neuroeng Rehabil. 2024 Mar 2;21(1):33. doi: 10.1186/s12984-024-01325-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AYMUN JAVED, MSPT principal investigator
Ripha International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power ball with static surface and Powerball with dynamic surface in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN Amjad, PHD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ABIL-HAND (time frame: Baseline- 1st week and 3rd week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07244133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.