Visual ImpairmentNCT05787223
Effects of Balance Training Exercises on Mobility in Open and Closed Environment in Children With Visual Impairments.
A study testing Baseline Treatment and Dynamic Training in people with Visual Impairment, run by Riphah International University at 1 site in Pakistan.
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). Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Visual Impairment
- What is being tested?
- Baseline Treatment and Dynamic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 9 Mar 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rising Sun Institute for Special Children
Lahore, Punjab Province, 51000
About this study
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.
- Conditions
- Visual Impairment
- Being tested
- Baseline Treatment, Dynamic Training
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline TreatmentOther
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 TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Other: Baseline Treatment |
| Experimental Group | Experimental | Not described Receives: Other: Baseline Treatment; Other: Dynamic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 8th week
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.
Measured: Baseline and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start9 Mar 2023
- Primary completion15 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha Kausar, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787223
- Sponsor's protocol ID
- REC/RCR & AHS/23/0705
- Status last verified
- Dec 2023
- First submitted
- 15 Mar 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29483748Parreira 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.
PubMed 28641161Winnick 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 at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balance Training Exercises on Mobility in Open and Closed Environment in Children With Visual Impairments.
- ClinicalTrials.gov ID
- NCT05787223
- Acronym / sponsor ID
- REC/RCR & AHS/23/0705
- Conditions
- Visual Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Baseline Treatment |
| Experimental Group | Experimental | Other: Baseline Treatment, Other: Dynamic Training |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline TreatmentControl 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 | Control Group, Experimental Group |
| Dynamic TrainingExperimental 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 | Other | Experimental Group |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Background: PubMed 29483748Ackland 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.
- Background: PubMed 28641161Parreira 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.
- BackgroundWinnick JP. The Performance of Visually Impaired Youngsters in Physical Education Activities: Implications for Mainstreaming. 1985;2(4).
- BackgroundBehar MP, Zucker DRJJoVI, Blindness. Sensory Awareness Exercises for the Visually Handicapped. 1976;70(4):146-8.
- BackgroundLewis V, Norgate S, Collis G, Reynolds RJBJoDP. The consequences of visual impairment for children's symbolic and functional play. 2000;18(3):449-64.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fareeha Kausar, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Treatment and Dynamic Training in people with Visual Impairment, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Time Up and Go Test (time frame: Baseline and 8th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05787223, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.