NCT05922215

Effects of Balance Training on Gait and Functional Strength in Children With Intellectual Disabilities

Completed NA Last updated 27 December 2023

What this trial tests

NA trial testing Dynamic Balance training in Intellectual Impairment in 22 participants. Completed in 30 August 2023.

Timeline

9 March 2023

Primary endpoint
15 August 2023

30 August 2023

Quick facts

Lead sponsor	Riphah International University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	22
Start date	9 March 2023
Primary completion	15 August 2023
Estimated completion	30 August 2023
Sites	1 location across Pakistan

Drugs / interventions tested

• Dynamic Balance training
• Static balance training

Conditions studied

• Intellectual Impairment — all drugs for Intellectual Impairment →

Sponsor

Riphah International University

Who can join

Adults 7 to 14, any sex, with Intellectual Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intellectual impairment is a developmental condition that first appears in childhood and causes substantial intellectual or cognitive limitations as well as inadequate adaptation to the demands of daily life. It may be viewed as a syndrome grouping (meta-syndrome), rather than as an illness or a disability; encompassing a wide range of clinical problems, including hereditary, viral, metabolic, and neurological issues. Prior to learning new abilities, there is a loss in cognitive functioning that is indicative of ID. Falling is a severe issue that affects people with intellectual disabilities frequently. Although studies based on retrospective data collected over time have not determined the exact prevalence of falling in the ID community, they have estimated that 30-60% of people fall within a 12-month period. Similar fall risk factors exist in the general population and in people with ID, such as advancing age, vision problems, and mobility issues. However, some characteristics, such as having frequent seizures and a high level of ambulation, seem more distinctive to ID. The purpose of this study is to analyze the effects of balance training on gait and functional strength in children with mild intellectual disabilities. This will be a Randomized Controlled Trial. Approval will be gained from the Ethical committee of the Riphah international university Lahore, Pakistan prior to the commencement of study. Written informed consent will be taken from all the patients and all information and data will be confidential. Subjects will be informed that there is no risk of study and they will be free to withdraw any time during process of study. 22 intellectually disabled children between the ages of 7 and 14 will be randomly allocated to the Experimental group (n=10) or a Control group (n=10). The Experimental group will be given the Baseline treatment comprising of Static balance training (i.e. heel and toe raises, alternate rising of the left and right foot above the floor and tandem standing.) alongside Dynamic Balance training (weight shifting forward, backward, sideward, and diagonally with eyes opened and eyes closed, walking toe-to-heel barefoot, side walking, reverse walking and one-foot jumps), and Progressive activity training (including stepping over/on obstacles, throwing and catching a ball, and kicking a ball.) for 40 minutes per day, twice each week for 8 weeks. Whereas, the Control group will continue their regular school schedule, which will include participation in physical education activities at the same frequency. Along with that, only Baseline treatment including Static balance training (i.e. alternate rising of the left and right foot above the floor and tandem standing.) will be given at the same intervals and for the same length of time as the intervention group, with the exception of additional Dynamic balance training and progressive activity training. The time up-and-go test, the 10-meter walk test and GMFM-88 were used to evaluate gait, and the Sit-to-stand test and the Stair Climbing test. were used to measure each participant's functional strength. Pre and Post treatment values will be evaluated and the Data will be analyzed using SPSS 22.0.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.