- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05787223
Effects of Balance Training Exercises on Mobility in Open and Closed Environment in Children With Visual Impairments.
December 26, 2023 updated by: Riphah International University
Visual impairment is used to describe any kind of vision loss, whether it's someone who cannot see at all or someone who has partial vision loss.
Visual impairment is classified on the basis of visual acuity like mild, moderate, severe, profound, near total visual impairment, no light perception (NLP).
Balance is defined as the ability to maintain one's equilibrium as the center of gravity when the COG shifts called (dynamic balance), as in walking and running, and while the center of gravity remains stationary (static balance).
Mobility is the ability of a patient to change and control their body position.
Physical mobility requires sufficient muscle strength and energy, along with adequate skeletal stability, joint function, and neuromuscular synchronization.
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.
24 patients will be divided into two Groups.
Group A will be the Control Group that will be given the baseline treatment of static balance training (static exercises like standing on balance board, bounce on one foot, heel rises/toe rises, standing on one foot, jumping on trampoline) and Group B will be the Experimental Group that will be provided with baseline treatment along with dynamic balance training (cross, side and tandem walking, step up and down, jumping and hopping on floor).
Exercises will be given the 40 minutes with 2 sessions per week over the period of 8 weeks.
Pre and Post treatment values will be evaluated.
The tools used will be Time Up and Go Test, GMFM-88, Wee FIM.
Data will be analyzed using SPSS 22.0 and mean and standard deviation will be calculated.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 51000
- Rising Sun Institute for Special Children
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 14 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both gender
- 08-14 Age
- Visual acuity is 20/70 with possible correction
- All participants are label with legally blind by an ophthalmologist.
- Able to follow the commands
Exclusion Criteria:
- Those who were unable to complete follow-up tests.
- No other neurological or orthopedic problems that could affect balance, and who could understand the instructions during the implementation of the exercises and tests.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
|
Control Group that will be provided with be given baseline treatment of static balance training (static exercise like standing on balance board, bounce on one foot, heel rises/toe rises, standing on one foot, jumping on trampoline)
Experimental Group that will be provided with base line treatment along with dynamic balance training (cross, side &tandem walking, step up and down, jumping &hopping on floor).
Exercises Will be given the 40 minutes with 2 sessions per week over the period of 08 weeks
|
|
Active Comparator: Control Group
|
Control Group that will be provided with be given baseline treatment of static balance training (static exercise like standing on balance board, bounce on one foot, heel rises/toe rises, standing on one foot, jumping on trampoline)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Time Up and Go Test
Time Frame: Baseline and 8th week
|
The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults
|
Baseline and 8th week
|
|
Gross Motor Function Measure (GMFM-88)
Time Frame: Baseline and 8th week
|
The Gross Motor Function Measure31 is a criterion-referenced assessment designed to be used with children with cerebral palsy.
It evaluates the child's ability to complete motor functions, such as rolling, crawling, sitting, standing, walking, running, stair use, and jumping.
A four-point ordinal scale of measurement is used to assess each item.
A score of 0 indicates the task cannot be done, 1 indicates the task can be initiated (<10% completion), 2 indicates partial completion of the task (10% to <100% completion), and 3 indicates the task can be completed.
|
Baseline and 8th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fareeha Kausar, PP-DPT, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ackland P, Resnikoff S, Bourne R. World blindness and visual impairment: despite many successes, the problem is growing. Community Eye Health. 2017;30(100):71-73. No abstract available.
- Parreira RB, Grecco LAC, Oliveira CS. Postural control in blind individuals: A systematic review. Gait Posture. 2017 Sep;57:161-167. doi: 10.1016/j.gaitpost.2017.06.008. Epub 2017 Jun 12.
- Winnick JP. The Performance of Visually Impaired Youngsters in Physical Education Activities: Implications for Mainstreaming. 1985;2(4).
- Behar MP, Zucker DRJJoVI, Blindness. Sensory Awareness Exercises for the Visually Handicapped. 1976;70(4):146-8.
- Lewis V, Norgate S, Collis G, Reynolds RJBJoDP. The consequences of visual impairment for children's symbolic and functional play. 2000;18(3):449-64.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2023
Primary Completion (Actual)
August 15, 2023
Study Completion (Actual)
August 30, 2023
Study Registration Dates
First Submitted
March 15, 2023
First Submitted That Met QC Criteria
March 15, 2023
First Posted (Actual)
March 28, 2023
Study Record Updates
Last Update Posted (Actual)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 26, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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