- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07404371
Efficacy of Sensory Reweighting Techniques for Balance and Risk of Fall in Chronic Ischemic Stroke Patients (SRT-IS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted as a randomized controlled trial to investigate the efficacy of sensory reweighting techniques in improving balance and reducing the risk of falls among patients with chronic ischemic stroke. Following ethical approval, participants will be recruited from selected rehabilitation centers using a non-probability purposive sampling technique. A total of 46 eligible participants, including an allowance for dropout, will be enrolled and randomly allocated into experimental and control groups using the sealed envelope method to ensure unbiased group assignment. Individuals aged 40-60 years with a stroke duration of more than six months, adequate cognitive function, and the ability to stand and walk with or without assistive devices will be included.
Baseline data will be collected prior to intervention using standardized outcome measures. Balance performance will be assessed using the Berg Balance Scale, a validated tool consisting of 14 functional tasks that evaluate postural control and balance during daily activities. Risk of falls will be measured using the Timed Up and Go test, which assesses functional mobility by recording the time taken to stand from a chair, walk a short distance, turn, return, and sit down. Demographic and clinical information such as age, gender, duration of stroke, use of assistive devices, and fall history will also be documented.
Participants allocated to the experimental group will undergo a structured sensory reweighting balance training program aimed at enhancing the central nervous system's ability to integrate visual, vestibular, and somatosensory inputs for postural control. The intervention will be administered three times per week for eight weeks, with each session lasting approximately 45 minutes. Training will include balance tasks performed under progressively challenging sensory conditions, such as standing on compliant surfaces, performing tasks with eyes closed, incorporating head movements during stance and gait, and engaging in dual-task activities. Exercise intensity and task complexity will be gradually increased according to individual tolerance while maintaining participant safety.
Participants in the control group will receive conventional balance training with the same frequency and duration as the experimental group. This program will focus on traditional static and dynamic balance exercises, including standing with a narrowed base of support, sit-to-stand practice, and forward and backward walking. No manipulation of sensory input will be included in this group, allowing comparison between standard balance rehabilitation and sensory reweighting-based training.
In addition to group-specific interventions, all participants will receive standard physiotherapy throughout the study period. This will include passive and active range of motion exercises, functional strengthening, and gait training tailored to individual needs. Standard therapy will be delivered at moderate intensity for 20-25 minutes per session, five days per week, to ensure uniform baseline rehabilitation across both groups. Written informed consent will be obtained from all participants, confidentiality will be maintained, participation will be voluntary, and individuals will be free to withdraw from the study at any time without affecting their standard care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Montiha Azeem, MSPTN
- Phone Number: 03479717317
- Email: muntahaazeem9@gmail.com
Study Contact Backup
- Name: Kanwal Mirani, MSPTN
- Phone Number: 0312-3474874
- Email: kanwalmiranikanwalmirani33@gmail.com
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- University of Lahore Teaching Hospital, Lahore
-
Contact:
- Montiha Azeem, MSPTN
- Phone Number: 03479717317
- Email: muntahaazeem9@gmail.com
-
Contact:
- Kanwal Mirani, MSPT N
- Phone Number: 0312-3474874
- Email: kanwalmiranikanwalmirani33@gmail.com
-
Principal Investigator:
- Kanwal Mirani, MSPTN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Diagnosed case of chronic ischemic stroke (duration >6 months post-stroke)
Both male and female patients with age range 40-60 years .
Able to stand and walk at least 10 feet (with or without assistive devices).
Mini-Mental State Examination (MMSE) score ≥24 (to ensure adequate cognitive ability to follow instructions).
Medically stable and cleared by a physician to participate in balance training.
Experiencing balance impairment and/or history of at least one fall in the past 6 months
Exclusion Criteria:
Hemorrhagic stroke patients or mixed stroke types
Severe visual, auditory, or vestibular impairments not correctable by aids (which would interfere with sensory reweighting assessment).
Other neurological conditions (e.g., Parkinson's disease, multiple sclerosis, peripheral neuropathy).
Musculoskeletal disorders significantly affecting balance (e.g., recent fracture, severe arthritis).
On medications that severely affect balance or cause dizziness (e.g., sedatives, high-dose antiepileptic.
Severe aphasia or communication disorders impeding participation in the intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group A Sensory Reweighting Balance Training Group
Participants in this arm will receive sensory reweighting-based balance training aimed at enhancing integration of visual, vestibular, and somatosensory inputs for postural control.
The intervention will be delivered three times per week for eight weeks, with each session lasting approximately 45 minutes.
Training will include balance tasks performed under altered sensory conditions such as reduced visual input, compliant surfaces, head movements, and dual-task activities.
Exercise difficulty will be progressively increased according to individual tolerance while ensuring participant safety.
|
Participants will receive sensory reweighting-based balance training aimed at improving postural control by enhancing the central nervous system's ability to integrate visual, vestibular, and somatosensory inputs.
Training will be conducted three times per week for eight weeks, with 45-minute sessions including warm-up, core balance exercises, and cool-down.
Exercises will be performed under altered sensory conditions, such as standing on foam surfaces, performing tasks with eyes closed, head movements during stance and gait, and dual-task activities.
Task difficulty will be progressively increased based on individual tolerance while maintaining safety.
|
|
Active Comparator: group B Conventional Balance Training Group
Participants in this arm will receive conventional balance training without sensory reweighting components.
The program will be delivered three times per week for eight weeks, with each session lasting approximately 45 minutes.
Exercises will focus on static and dynamic balance tasks, including standing with a narrow base, sit-to-stand practice, and forward/backward walking.
No manipulation of sensory input will be included.
Training intensity and duration will be matched to the experimental group to allow fair comparison of outcomes.
|
Participants will receive conventional balance training without sensory reweighting components.
The program will be delivered three times per week for eight weeks, with each session lasting approximately 45 minutes.
Exercises will focus on static and dynamic balance tasks such as standing with a narrow base, sit-to-stand practice, and forward/backward walking.
No manipulation of sensory input will be included.
Training intensity and duration will be matched to the experimental group to ensure comparability of outcomes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Performance
Time Frame: Baseline and 8 weeks post-intervention
|
Balance will be measured using the Berg Balance Scale (BBS), a validated clinical tool consisting of 14 functional tasks assessing postural control, stability, and fall risk in chronic ischemic stroke patients.
Each task is scored from 0 (unable to perform) to 4 (independent and safe), with a maximum total score of 56.
Higher scores indicate better balance, and scores below 45 suggest increased risk of falls.
Assessments will be conducted at baseline and after completion of the 8-week intervention to evaluate the efficacy of sensory reweighting balance training compared to conventional balance exercises.
|
Baseline and 8 weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk of Falls
Time Frame: Baseline and 8 weeks post-intervention
|
Risk of falls will be evaluated using the Timed Up and Go (TUG) test, a standardized and widely used measure of functional mobility and dynamic balance in neurological populations.
The test records the time (in seconds) required for a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down.
Shorter completion times indicate better mobility and lower fall risk, while times greater than 20 seconds suggest an increased risk of falls.
The TUG test will be administered at baseline and after completion of the 8-week intervention to compare changes between the sensory reweighting training group and the conventional balance training group.
|
Baseline and 8 weeks post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kanwal Mirani, MSPTN, The University of Lahore, Lahore
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UOL/IREB/25/15/03/30
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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