NCT05392296

Brief Summary

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.

Trial Health

87
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
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

May 23, 2022

Last Update Submit

January 4, 2023

Conditions

Keywords

power ballStrengthening exercisesHand gripDevelopmental delayDynamometer

Outcome Measures

Primary Outcomes (2)

  • Change in Grip strength by Hand held Dynamometer

    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

    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

Study Arms (2)

Power ball

EXPERIMENTAL

experimental group getting the power ball training with conventional treatment

Other: Power ballOther: isometric hand grip strengthening exercises

Conventional

ACTIVE COMPARATOR

group will be control group getting the conventional treatment (isometric hand grip training exercises)

Other: isometric hand grip strengthening exercises

Interventions

experimental group getting the power ball training with conventional treatment.

Power ball

conventional treatment (isometric hand grip training exercises)

ConventionalPower ball

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 7-12 years
  • Both genders (male /female)
  • Moderate developmental delay
  • Affected fine motor skill

You may not qualify if:

  • With another neurological conditions(cerebral palsy, down's syndrome, Autism)
  • Genetic disorder-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rising Sun Institute For Special Children, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 30997518BACKGROUND
  • 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.

    PMID: 29054862BACKGROUND
  • Vitrikas K, Savard D, Bucaj M. Developmental Delay: When and How to Screen. Am Fam Physician. 2017 Jul 1;96(1):36-43.

    PMID: 28671370BACKGROUND
  • 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.

    PMID: 24488746BACKGROUND
  • 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.

    PMID: 30116118BACKGROUND

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sidra Afzal, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

March 15, 2022

Primary Completion

October 15, 2022

Study Completion

October 31, 2022

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations