- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392296
Effects of Power Ball on Grip Strength in Children With Developmental Delay.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Rising Sun Institute For Special Children, Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 7-12 years
- Both genders (male /female)
- Moderate developmental delay
- Affected fine motor skill
Exclusion Criteria:
- With another neurological conditions(cerebral palsy, down's syndrome, Autism)
- Genetic disorder-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Power ball
experimental group getting the power ball training with conventional treatment
|
experimental group getting the power ball training with conventional treatment.
conventional treatment (isometric hand grip training exercises)
|
|
Active Comparator: Conventional
group will be control group getting the conventional treatment (isometric hand grip training exercises)
|
conventional treatment (isometric hand grip training exercises)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Grip strength by Hand held Dynamometer
Time Frame: Baseline, 7th and 14th day
|
A small portable device is held by the examiner and placed against the patient's limb during a maximal isometric contraction.
A hand held dynamometer, however, takes the force a patient generates and transmits it through a transducer, quantifies the force, and then presents the data in a digital format.
Health professionals can use this muscle strength testing equipment to measure muscle strength efficiently and effectively across the board.
The purpose of using a hand dynamometer is to measure the maximum isometric strength of the hand and forearm muscles.
The hand dynamometer can be adjusted for hand size and must be calibrated regularly for consistent results
|
Baseline, 7th and 14th day
|
|
Change in ABILHAND-KIDS tool scores
Time Frame: Baseline and 1 month
|
The ABILHAND KIDS was originally developed by using the Rasch measurement model. It allows to convert ordinal score into linear measure located on unidimensional score. Procedure Parents are asked to fill the questionnaire according to child ability to do manual task ,ease in doing fine motor task and difficulty in performing activities, when the task are done1 Without other technical and human help(even if child actually uses help in daily life) 2 Irrespective of the limb actually used to do activity 3 Whatever strategy was used(any compensation is allowed |
Baseline and 1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sidra Afzal, PP-DPT, Riphah International University
Publications and helpful links
General Publications
- Choo YY, Agarwal P, How CH, Yeleswarapu SP. Developmental delay: identification and management at primary care level. Singapore Med J. 2019 Mar;60(3):119-123. doi: 10.11622/smedj.2019025.
- Mithyantha R, Kneen R, McCann E, Gladstone M. Current evidence-based recommendations on investigating children with global developmental delay. Arch Dis Child. 2017 Nov;102(11):1071-1076. doi: 10.1136/archdischild-2016-311271.
- Vitrikas K, Savard D, Bucaj M. Developmental Delay: When and How to Screen. Am Fam Physician. 2017 Jul 1;96(1):36-43.
- Mussatto KA, Hoffmann RG, Hoffman GM, Tweddell JS, Bear L, Cao Y, Brosig C. Risk and prevalence of developmental delay in young children with congenital heart disease. Pediatrics. 2014 Mar;133(3):e570-7. doi: 10.1542/peds.2013-2309. Epub 2014 Feb 2.
- Yoo S, Park SK, Yoon S, Lim HS, Ryu J. Comparison of Proprioceptive Training and Muscular Strength Training to Improve Balance Ability of Taekwondo Poomsae Athletes: A Randomized Controlled Trials. J Sports Sci Med. 2018 Aug 14;17(3):445-454. eCollection 2018 Sep.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- REC/RCR & AHS/22/0703
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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