CClinicalTrials.gg
CompletedNCT05922215Updated Dec 27, 2023

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

An interventional study of Dynamic Balance training and Static balance training in Intellectual Impairment, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 7 Years to 14 Years. Per ClinicalTrials.gov, last updated 2023-12-27.

Sponsored by Riphah International University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
7 Years to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intellectual Impairment
03

In context

Intellectual Disability

363 studies on the registry are indexed under Intellectual Disability; 103 are open to participants now.

This study's enrollment of 22 is below the median of 53 across 236 interventional studies indexed under Intellectual Disability.

Browse Intellectual Disability studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Experimental Group

    Other: Dynamic Balance training · Other: Static balance training

  • Active comparator
    Control Group

    Other: Static balance training

Interventions

  • OtherDynamic Balance training

    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.

  • OtherStatic balance training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 8th week

  2. 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.

    Time frame: Baseline and 8th week

  3. 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.

    Time frame: baseline and 8th week

07

Study locations

1 site
  • Rising Sun Institute for special children
    Lahore, Punjab 51000, Pakistan
08

References and documents

Publications

  • 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. PubMed 20854287 ↗
  • 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. PubMed 29975552 ↗
  • 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. PubMed 25830443 ↗
  • 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. PubMed 30230530 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05922215
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jun 28, 2023
Start date
Mar 9, 2023
Primary completion
Aug 15, 2023
Completion
Aug 30, 2023
Last update
Dec 27, 2023

Study contacts

Fareeha Kausar, PP-DPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion