Effects of Power Ball on Grip Strength in Children With Developmental Delay.

January 4, 2023 updated by: Riphah International University
Developmental delay refers to the child who does not perform the normal milestones as other children accomplish in the same age within time or somehow late but can achieve them. While if the delay is found in two or more than two areas of the developmental skill it is known as Global Developmental Delay (GDD). It is divided into mild, moderate and severe developmental delay contributed by many other causes like prenatal, perinatal, postnatal and socioeconomic factors. The objective of the study is to determine the effects of power ball on grip strengthening children with developmental delay. In this study, we will randomly assigned 28 children into two groups, One group will be control group getting the conventional treatment (isometric hand grip training exercises) and other will be experimental group getting the power ball training with conventional treatment. During the sessions hand held dynamometer is use to check the grip strength. By using power ball grip strength in children with Developmental Delay can be improved.

Study Overview

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Rising Sun Institute For Special Children, Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sidra Afzal, PP-DPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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