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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05392296
Other study ID # REC/RCR & AHS/22/0703
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 15, 2022
Est. completion date October 31, 2022

Study information

Verified date January 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date October 31, 2022
Est. primary completion date October 15, 2022
Accepts healthy volunteers No
Gender All
Age group 7 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Power ball
experimental group getting the power ball training with conventional treatment.
isometric hand grip strengthening exercises
conventional treatment (isometric hand grip training exercises)

Locations

Country Name City State
Pakistan Rising Sun Institute For Special Children, Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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