StrokeNCT07448948
Interactive Posturographic Balance Training Added to Conventional Rehabilitation in Chronic Stroke
A study testing Biofeedback-Based Interactive Posturographic Balance Training and Conventional Rehabilitation Program in people with Stroke and Postural Balance, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke, Postural Balance
- What is being tested?
- Biofeedback-Based Interactive Posturographic Balance Training and Conventional Rehabilitation Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 15 Oct 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Istanbul, Turkey
Istanbul, Istanbul, 34147
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Postural Balance
- Being tested
- Biofeedback-Based Interactive Posturographic Balance Training, Conventional Rehabilitation Program
- Keywords
- Chronic stroke, Balance training, Posturography, Biofeedback, Berg Balance Scale, Fall risk
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback-Based Interactive Posturographic Balance TrainingDevice
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.
Conventional Rehabilitation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Posturographic Balance Training + Conventional Rehabilitation | Experimental | 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. Receives: Device: Biofeedback-Based Interactive Posturographic Balance Training |
| Conventional Rehabilitation | Active comparator | 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. Receives: Behavioral: Conventional Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
The Berg Balance Scale is a 14-item clinical measure of balance performance scored from 0 to 56, with higher scores indicating better balance.
Measured: Baseline and 8 weeks
Secondary outcomes (3)
Change in Barthel Index score from baseline to 8 weeks
The Barthel Index assesses functional independence in activities of daily living and ranges from 0 to 100. Higher scores indicate greater independence.
Measured: Baseline and 8 weeks
Change in Fall Risk Index from baseline to 8 weeks
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.
Measured: Baseline and 8 weeks
Change in Hospital Anxiety and Depression Scale (HADS) total score from baseline to 8 weeks
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start15 Feb 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups. One group received conventional rehabilitation combined with biofeedback-based interactive posturographic balance training, while the control group received conventional rehabilitation alone. Both groups underwent intervention for eight weeks without crossover between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448948
- Sponsor's protocol ID
- CRS-TETRAX-2021
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data protection regulations and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interactive Biofeedback-Based Posturographic Balance Training Added to Conventional Rehabilitation in Chronic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07448948
- Acronym / sponsor ID
- CRS-TETRAX-2021
- Conditions
- Stroke, Postural Balance
- Keywords
- Chronic stroke, Balance training, Posturography, Biofeedback, Berg Balance Scale, Fall risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 4 Mar 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups. One group received conventional rehabilitation combined with biofeedback-based interactive posturographic balance training, while the control group received conventional rehabilitation alone. Both groups underwent intervention for eight weeks without crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Interactive Posturographic Balance Training + Conventional Rehabilitation | Experimental | Device: Biofeedback-Based Interactive Posturographic Balance TrainingParticipants 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. |
| Conventional Rehabilitation | Active comparator | Behavioral: Conventional Rehabilitation ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| Biofeedback-Based Interactive Posturographic Balance TrainingIntervention 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. | Device | Interactive Posturographic Balance Training + Conventional Rehabilitation |
| Conventional Rehabilitation ProgramParticipants 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. | Behavioural | Conventional Rehabilitation |
Primary outcome
Berg Balance Scale (BBS)
Time frame: Baseline and 8 weeks
The Berg Balance Scale is a 14-item clinical measure of balance performance scored from 0 to 56, with higher scores indicating better balance.
3 secondary outcomes
Change in Barthel Index score from baseline to 8 weeks
Time frame: Baseline and 8 weeks
Change in Fall Risk Index from baseline to 8 weeks
Time frame: Baseline and 8 weeks
Change in Hospital Anxiety and Depression Scale (HADS) total score from baseline to 8 weeks
Time frame: Baseline and 8 weeks
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 4 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data protection regulations and ethical considerations.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback-Based Interactive Posturographic Balance Training and Conventional Rehabilitation Program in people with Stroke and Postural Balance, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 4 Mar 2026. 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 Turkey (Türkiye). 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?
Berg Balance Scale (BBS) (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2026.