NCT07244133

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2026

Expected
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Down Syndrome (DS)Powerball,Upper extremity, Children

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline- 1st week and 3rd week

Secondary Outcomes (1)

  • BOT-2

    Baseline- 1st week and 3rd week

Study Arms (2)

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.

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.

Other: Powerball with dynamic surface

Interventions

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.

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 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.

The intervention will be powerball exercises on dynamic surface

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with Down Syndrome
  • Aged between 6-10 years
  • Both Genders
  • Ability to follow commands and instructions

You may not qualify if:

  • Children with any orthopedic and neurological conditions associated with the syndrome • Children with any other Genetic disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imran Amjad

Lahore, Punjab Province, 5400, Pakistan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38431591BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • AYMUN JAVED, MSPT

    Ripha International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MUHAMMAD ASIF JAVED, MSPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

October 22, 2025

Primary Completion

June 2, 2026

Study Completion (Estimated)

June 16, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations