Effects of Balance Training on Gait and Functional Strength in Children With Intellectual Disabilities
Primary Purpose
Intellectual Impairment
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dynamic Balance training
Static balance training
Sponsored by
About this trial
This is an interventional other trial for Intellectual Impairment
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.
Sites / Locations
- Rising Sun Institute for special childrenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05922215
First Posted
March 15, 2023
Last Updated
June 26, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05922215
Brief Title
Effects of Balance Training on Gait and Functional Strength in Children With Intellectual Disabilities
Official Title
Effects of Balance Training on Gait and Functional Strength in Children With Intellectual Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Impairment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Dynamic Balance training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Static balance training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Time Up and Go test
Description
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.
Time Frame
Baseline and 8th week
Title
Change in Sit to stand test
Description
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.
Time Frame
Baseline and 8th week
Title
Change in Stair climb test
Description
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.
Time Frame
baseline and 8th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Ph.D
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Fareeha Kausar, PP-DPT
Phone
03216758180
Email
fareeha.kausar@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fareeha Kausar, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rising Sun Institute for special children
City
Lahore
State/Province
Punjab
ZIP/Postal Code
51000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fareeha Kausar, PP-DPT
Phone
03216758180
Email
fareeha.kausar@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Mahasin Mohd Aslam, MSPT (Pead)
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20854287
Citation
Vuijk PJ, Hartman E, Scherder E, Visscher C. Motor performance of children with mild intellectual disability and borderline intellectual functioning. J Intellect Disabil Res. 2010 Nov;54(11):955-65. doi: 10.1111/j.1365-2788.2010.01318.x. Epub 2010 Sep 20.
Results Reference
background
PubMed Identifier
29975552
Citation
Wang J, Gao Y, Kwok HHM, Huang WYJ, Li S, Li L. Children with Intellectual Disability Are Vulnerable to Overweight and Obesity: A Cross-Sectional Study among Chinese Children. Child Obes. 2018 Jul;14(5):316-326. doi: 10.1089/chi.2018.0015. Epub 2018 Jul 5.
Results Reference
background
PubMed Identifier
25830443
Citation
Stanish HI, Curtin C, Must A, Phillips S, Maslin M, Bandini LG. Physical Activity Enjoyment, Perceived Barriers, and Beliefs Among Adolescents With and Without Intellectual Disabilities. J Phys Act Health. 2016 Jan;13(1):102-10. doi: 10.1123/jpah.2014-0548. Epub 2015 Apr 1.
Results Reference
background
PubMed Identifier
30230530
Citation
Maiano C, Hue O, Morin AJS, Lepage G, Tracey D, Moullec G. Exercise interventions to improve balance for young people with intellectual disabilities: a systematic review and meta-analysis. Dev Med Child Neurol. 2019 Apr;61(4):406-418. doi: 10.1111/dmcn.14023. Epub 2018 Sep 19.
Results Reference
background
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Effects of Balance Training on Gait and Functional Strength in Children With Intellectual Disabilities
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