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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05787223
Other study ID # REC/RCR & AHS/23/0705
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 9, 2023
Est. completion date August 30, 2023

Study information

Verified date December 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 30, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers No
Gender All
Age group 8 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Baseline Treatment
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)
Dynamic Training
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

Locations

Country Name City State
Pakistan Rising Sun Institute for Special Children Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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.

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. — View Citation

Winnick JP. The Performance of Visually Impaired Youngsters in Physical Education Activities: Implications for Mainstreaming. 1985;2(4).

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline and 8th week
Primary 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. Baseline and 8th week
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