Effects of Balance Training Exercises on Mobility in Open and Closed Environment in Children With Visual Impairments.
Primary Purpose
Visual Impairment
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Baseline Treatment
Dynamic Training
Sponsored by
About this trial
This is an interventional other trial for Visual Impairment
Eligibility Criteria
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.
Sites / Locations
- Rising Sun Institute for Special ChildrenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Experimental Group
Arm Description
Outcomes
Primary Outcome Measures
Change in Time Up and Go Test
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
Gross Motor Function Measure (GMFM-88)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05787223
First Posted
March 15, 2023
Last Updated
March 15, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05787223
Brief Title
Effects of Balance Training Exercises on Mobility in Open and Closed Environment in Children With Visual Impairments.
Official Title
Effects of Balance Training Exercises on Mobility in Open and Closed Environment in Children With Visual Impairments.
Study Type
Interventional
2. Study Status
Record Verification Date
March 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
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Title
Experimental Group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Baseline Treatment
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Dynamic Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Time Up and Go Test
Description
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
Time Frame
Baseline and 8th week
Title
Gross Motor Function Measure (GMFM-88)
Description
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.
Time Frame
Baseline and 8th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Mubashra Tariq, MSPT (Pead)
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29483748
Citation
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.
Results Reference
background
PubMed Identifier
28641161
Citation
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.
Results Reference
background
Citation
Winnick JP. The Performance of Visually Impaired Youngsters in Physical Education Activities: Implications for Mainstreaming. 1985;2(4).
Results Reference
background
Citation
Behar MP, Zucker DRJJoVI, Blindness. Sensory Awareness Exercises for the Visually Handicapped. 1976;70(4):146-8.
Results Reference
background
Citation
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.
Results Reference
background
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Effects of Balance Training Exercises on Mobility in Open and Closed Environment in Children With Visual Impairments.
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