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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
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)
Other: 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
Active Comparator: Control Group
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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