- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07448948
Interactive Posturographic Balance Training Added to Conventional Rehabilitation in Chronic Stroke
Effect of Interactive Biofeedback-Based Posturographic Balance Training Added to Conventional Rehabilitation in Chronic Stroke: A Randomized Controlled Trial
Stroke frequently leads to long-term balance impairments, increased fall risk, and reduced independence in daily activities. In chronic stroke patients, deficits in sensory integration and postural control may persist despite conventional rehabilitation programs. Additional targeted balance interventions may enhance recovery by improving multisensory processing and motor control.
This study investigates whether adding biofeedback-based interactive posturographic balance training to conventional rehabilitation improves balance performance, fall risk, functional independence, and psychological well-being in individuals with chronic stroke. Participants were randomly assigned to receive either conventional rehabilitation alone or conventional rehabilitation combined with interactive balance training for eight weeks. Outcomes were assessed using validated clinical scales measuring balance, fall risk, daily functioning, and emotional status.
Study Overview
Status
Conditions
Detailed Description
Stroke is a major cause of long-term disability and frequently results in persistent impairments in postural control and balance. In individuals with chronic stroke, altered sensory integration and impaired motor coordination contribute to increased fall risk and reduced functional independence. Although conventional rehabilitation programs address strength, mobility, and functional training, balance deficits may remain due to insufficient multisensory challenge and limited task-specific feedback.
Biofeedback-based interactive posturographic systems provide real-time visual and sensory feedback during standing tasks and systematically challenge postural control under varying sensory conditions. Such interventions may enhance motor learning and promote adaptive sensory reweighting mechanisms by exposing individuals to controlled visual deprivation and head-position alterations.
This prospective, single-blind randomized controlled study was conducted in individuals with chronic stroke (>6 months post-event). Participants were randomly assigned to receive either conventional rehabilitation alone or conventional rehabilitation combined with interactive posturographic balance training. The intervention period lasted eight weeks, with sessions conducted five days per week.
The primary objective of the study was to determine whether adding biofeedback-based interactive posturographic balance training improves clinical balance performance. Secondary objectives included evaluating effects on fall risk, functional independence, and psychological status.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34147
- University of Health Sciences, Istanbul, Turkey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At least 6 months had elapsed since stroke onset
- They were ambulatory prior to stroke
- They were able to stand independently for at least 2 minutes
- Mini-Mental State Examination (MMSE) score ≥22
Exclusion Criteria:
- Medical conditions contraindicating participation in an exercise program
- Additional disorders affecting balance assessment (vertebrobasilar or peripheral vestibular insufficiency, significant visual impairment, neglect, cognitive impairment, major lower extremity contracture, neuromuscular disease, other neurological pathology, impaired joint position sense)
- Previous history of stroke
- Cerebellar involvement (dysmetria, dysdiadochokinesia, ataxia)
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: Interactive Posturographic Balance Training + Conventional Rehabilitation
Participants received conventional rehabilitation (45 minutes per session, 5 sessions per week) combined with biofeedback-based interactive posturographic balance training (25 minutes per session) for 8 weeks.
The balance training was conducted using a multisensory posturographic system providing real-time visual feedback under varying sensory conditions.
The conventional rehabilitation program included neurophysiological facilitation techniques, range of motion exercises, strengthening exercises, postural control training, weight-shifting exercises, and gait training.
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Intervention Description (Experimental Arm) Participants received biofeedback-based interactive posturographic balance training using a multisensory platform that provides real-time visual feedback based on vertical pressure fluctuations detected from four force plates under the heels and forefeet. The system systematically challenges postural control under different sensory conditions, including eyes open, eyes closed, unstable surface, and head-position variations. Training sessions lasted 25 minutes, five days per week, for eight weeks and were conducted in addition to a standardized conventional rehabilitation program. |
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Active Comparator: Conventional Rehabilitation
Participants received conventional rehabilitation only (45 minutes per session, 5 sessions per week) for 8 weeks.
The program consisted of neurophysiological facilitation techniques, range of motion exercises, strengthening exercises, postural control training, weight-shifting exercises, and gait training.
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Participants received a standardized conventional rehabilitation program consisting of neurophysiological facilitation techniques, range of motion exercises, muscle strengthening exercises, postural control training, weight-shifting exercises, and gait training.
Sessions lasted 45 minutes per day, five days per week, for eight weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale (BBS)
Time Frame: Baseline and 8 weeks
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The Berg Balance Scale is a 14-item clinical measure of balance performance scored from 0 to 56, with higher scores indicating better balance.
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Baseline and 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Barthel Index score from baseline to 8 weeks
Time Frame: Baseline and 8 weeks
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The Barthel Index assesses functional independence in activities of daily living and ranges from 0 to 100.
Higher scores indicate greater independence.
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Baseline and 8 weeks
|
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Change in Fall Risk Index from baseline to 8 weeks
Time Frame: Baseline and 8 weeks
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The Fall Risk Index is derived from computerized posturographic assessment and reflects the estimated percentage risk of falling.
Scores range from 0 to 100, with higher scores indicating greater fall risk.
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Baseline and 8 weeks
|
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Change in Hospital Anxiety and Depression Scale (HADS) total score from baseline to 8 weeks
Time Frame: Baseline and 8 weeks
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The HADS is a 14-item questionnaire assessing anxiety and depression symptoms.
Total scores range from 0 to 42, with higher scores indicating greater psychological distress.
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Baseline and 8 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRS-TETRAX-2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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