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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Intellectual Impairment

Intervention / Treatment
-----------------
* Other: Dynamic Balance training
* Other: Static balance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys and Girls with Mild Intellectual Disabilities (IQ range 50-69) Age group: 7-14 years Students from a Special Education School Exclusion Criteria: CP and Down's syndrome Those who were unable to complete follow-up tests. Subjects who took part in less than 80% of the intervention program. Participants with any psychological or behavioral issues.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br> | Other: Dynamic Balance training<br>* The Experimental group will be given the Baseline treatment comprising of Stretching & 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 which will include (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 (such as stepping over/on obstacles, throwing and catching a ball, and kicking a ball.) for 40 minutes per day, twice each week for 8 weeks.<br>Other: Static balance training<br>* The Control group will continue their regular school schedule, which will include participation in physical education activities at the same frequency. Along with that Baseline treatment including Static balance training (i.e. alternate rising of the left and right foot above the floor and tandem standing.) only, 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.<br>|
| Active Comparator: Control Group<br> | Other: Static balance training<br>* The Control group will continue their regular school schedule, which will include participation in physical education activities at the same frequency. Along with that Baseline treatment including Static balance training (i.e. alternate rising of the left and right foot above the floor and tandem standing.) only, 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Time Up and Go test | The Time Up and Go test (TUG) is a quick test that measures balance in both the static and dynamic planes. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require. | Baseline and 8th week | 
| Change in Sit to stand test | The Sit to stand also known as the 30 Second Chair Stand Test (30CST) is administered to test leg strength and endurance. Equipment: A chair with a straight back without arm rests (seat 17 high), and a stopwatch. Method: The participant is urged to complete as many full stands as they can in the allotted 30 seconds. Between each stand, the person is told to sit down completely. The tester silently counts the completion of each correct stand while keeping an eye on the participant's performance to verify perfect form. | Baseline and 8th week | 
| Change in Stair climb test | The stair climb test, also known as the stair climb power test, is a field-based evaluation of lower body strength, power, and physical function that is clinically relevant, safe, and affordable. Equipment: Stairs (8 - 14 steps) with handrails, stopwatch. Scoring: Total time to ascend and descend steps is recorded to the nearest 100th of a second. The patient should use the assistive device (if any) normally used to perform the activity at the time of testing. | baseline and 8th week |