StrokeNCT07471919
Robot-Assisted Gait Training vs Visual Feedback Balance Training in Stroke
A study testing Robot-Assisted Gait Training and Visual Feedback Balance Training in people with Stroke and Gait Impairment, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Stroke frequently leads to balance impairment and gait dysfunction, increasing fall risk and limiting functional independence. Technology-assisted rehabilitation approaches such as robot-assisted gait training and visual feedback balance training have been shown to improve balance and mobility in stroke patients. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Stroke, Gait Impairment, Balance Impairment
- What is being tested?
- Robot-Assisted Gait Training and Visual Feedback Balance Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 15 Aug 2026
- Phase
- Interventional
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-85 years
- Diagnosis of ischemic or hemorrhagic stroke confirmed by clinical and radiological findings
- Functional Ambulation Category (FAC) ≥ 3
- Modified Ashworth Scale ≤ 2 (lower extremity)
- Ability to understand and follow simple verbal instructions
- Mini-Mental State Examination (MMSE) score ≥ 23
Who cannot join
- Unstable cardiopulmonary conditions
- Severe musculoskeletal disorders affecting standing or walking
- Severe aphasia preventing participation in assessments
- Severe visual impairment interfering with balance testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmet Burak Mavuş, MSc contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
AIBU Izzet Baysak Physical Treatment and Rehabilitation Hospital
Bolu
Yakup ERDEN, MD, +905556692721, yakuperden@hotmail.com
About this study
Official title: Comparison of Robot-Assisted Gait Training and Visual Feedback Balance Training on Balance and Gait Outcomes in Patients With Stroke
Stroke frequently leads to balance impairment and gait dysfunction, increasing fall risk and limiting functional independence. Technology-assisted rehabilitation approaches such as robot-assisted gait training and visual feedback balance training have been shown to improve balance and mobility in stroke patients.
This randomized, assessor-blinded clinical trial aims to compare the effects of robot-assisted gait training and visual feedback balance training on balance and gait outcomes in patients with subacute and chronic stroke. Both interventions are part of routine clinical rehabilitation practice. Participants will be evaluated at baseline and after 4 weeks of intervention using clinical balance, gait, and functional assessments.
Read the detailed description
Stroke is a leading cause of neurological disability worldwide and is frequently associated with gait disturbances and impaired balance. Approximately 80% of stroke survivors experience walking limitations, and many are at increased risk of falls due to postural instability. Restoring balance and independent ambulation is therefore a primary goal of stroke rehabilitation.
Technology-assisted rehabilitation approaches have been increasingly integrated into clinical practice. Robot-assisted gait training provides repetitive, task-specific, and controlled gait patterns that may enhance motor relearning and postural control. Visual feedback balance training using computerized posturography systems aims to improve weight shifting, postural stability, and dynamic balance through real-time feedback.
Although both interventions have demonstrated beneficial effects when combined with conventional rehabilitation, direct comparisons between these two technology-based approaches under similar treatment dosage conditions are limited.
This prospective, randomized, assessor-blinded clinical trial will compare robot-assisted gait training and visual feedback balance training in subacute and chronic stroke patients receiving inpatient rehabilitation. Both interventions are routinely applied in the clinical setting, and no additional experimental procedures will be introduced.
Participants will receive 4 weeks of intervention. Outcomes will be assessed at baseline and after treatment using the Berg Balance Scale as the primary outcome measure, along with secondary measures including functional mobility, gait speed, motor recovery, fear of falling, functional independence, and posturography-derived balance parameters.
- Conditions
- Stroke, Gait Impairment, Balance Impairment
- Being tested
- Robot-Assisted Gait Training, Visual Feedback Balance Training
- Keywords
- Stroke rehabilitation, Robot-assisted gait training, Visual feedback balance training, Balance impairment, Gait impairment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Gait TrainingDevice
Robot-Assisted Gait Training (RoboGait®) Robot-assisted gait training will be delivered using the RoboGait® device (Bama Technology, METU Technokent, Ankara, Türkiye). The system provides repetitive, task-specific gait training with controlled movement patterns to improve dynamic balance, gait symmetry, and motor relearning. Sessions will be performed twice weekly for 4 weeks, each lasting 30 minutes. Body weight support and gait parameters will be adjusted according to the patient's clinical status and tolerance.
Other: Conventional Rehabilitation Program All participants will receive conventional rehabilitation for 40 minutes per session, 5 days per week for 4 weeks. The program includes static and dynamic balance exercises, lower extremity and trunk strengthening, weight shifting, sit-to-stand training, turning activities, and gait-related balance exercises under therapist supervision. Exercise progression will be individualized based on functional capacity and safety.
Visual Feedback Balance TrainingDevice
Visual Feedback Balance Training Visual feedback balance training will be performed using the ProKin 252 system (TecnoBody S.R.L., Bergamo, Italy). The system provides real-time visual feedback to improve postural stability, weight shifting, and dynamic balance control. Sessions will be conducted twice weekly for 4 weeks, each lasting 30 minutes. Training difficulty will be progressively adjusted according to patient performance and safety.
Other: Conventional Rehabilitation Program All participants will receive conventional rehabilitation for 40 minutes per session, 5 days per week for 4 weeks. The program includes static and dynamic balance exercises, lower extremity and trunk strengthening, weight shifting, sit-to-stand training, turning activities, and gait-related balance exercises under therapist supervision. Exercise progression will be individualized based on functional capacity and safety.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Gait Training Group | Active comparator | Robot-Assisted Gait Training Conventional Rehabilitation Program Receives: Device: Robot-Assisted Gait Training |
| Visual Feedback Balance Training Group | Active comparator | Visual Feedback Balance Training Conventional Rehabilitation Program Receives: Device: Visual Feedback Balance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning.
Measured: Before Treatment
Berg Balance Scale
The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning.
Measured: 4 Week After Treatment
Secondary outcomes (20)
Timed Up and Go Test
The Timed Up and Go Test assesses functional mobility and dynamic balance. Participants are instructed to stand up from a chair, walk 3 meters, turn, walk back, and sit down. The time required to complete the task is recorded in seconds.
Measured: Before Treatment
Timed Up and Go Test
The Timed Up and Go Test assesses functional mobility and dynamic balance. Participants are instructed to stand up from a chair, walk 3 meters, turn, walk back, and sit down. The time required to complete the task is recorded in seconds.
Measured: 4 Week After Treatment
10-Meter Walk Test
The 10-Meter Walk Test assesses gait speed over a short distance. Participants are instructed to walk 10 meters at a comfortable pace, and walking speed is calculated based on the time required to complete the distance. Higher walking speed reflects better gait performance.
Measured: Before Treatment
10-Meter Walk Test
The 10-Meter Walk Test assesses gait speed over a short distance. Participants are instructed to walk 10 meters at a comfortable pace, and walking speed is calculated based on the time required to complete the distance. Higher walking speed reflects better gait performance.
Measured: 4 Week After Treatment
Fugl-Meyer Assessment - Lower Extremity
The Fugl-Meyer Assessment for the lower extremity evaluates motor impairment following stroke, including reflex activity, movement synergies, coordination, and voluntary movement control.Each item is scored with a 3-point ordinal scale (0: unable at all, 1: partially able, 2: fully able). Higher total scores reflect better lower limb motor function.
Measured: Before Treatment
Fugl-Meyer Assessment - Lower Extremity
The Fugl-Meyer Assessment for the lower extremity evaluates motor impairment following stroke, including reflex activity, movement synergies, coordination, and voluntary movement control.Each item is scored with a 3-point ordinal scale (0: unable at all, 1: partially able, 2: fully able). Higher total scores reflect better lower limb motor function.
Measured: 4 Week After Treatment
Barthel Index
The Barthel Index measures functional independence in activities of daily living, including mobility, transfers, feeding, dressing, and personal care. Scores range from 0 to 100, with higher scores indicating greater independence.
Measured: Before Treatment
Barthel Index
The Barthel Index measures functional independence in activities of daily living, including mobility, transfers, feeding, dressing, and personal care. Scores range from 0 to 100, with higher scores indicating greater independence.
Measured: 4 Week After Treatment
Falls Efficacy Scale - International
The Falls Efficacy Scale-International assesses concern about falling during daily activities. The scale consists of 16 items rated on a 4-point Likert scale. Total scores range from 16 to 64, with higher scores indicating greater fear of falling.
Measured: Before Treatment
Falls Efficacy Scale-International
The Falls Efficacy Scale-International assesses concern about falling during daily activities. The scale consists of 16 items rated on a 4-point Likert scale. Total scores range from 16 to 64, with higher scores indicating greater fear of falling.
Measured: 4 Week After Treatment
Functional Ambulation Category
The Functional Ambulation Category is a 6-level scale that classifies ambulation ability based on the amount of physical assistance required. Higher levels indicate more independent walking performance.
Measured: Before Treatment
Functional Ambulation Category
The Functional Ambulation Category is a 6-level scale that classifies ambulation ability based on the amount of physical assistance required. Higher levels indicate more independent walking performance.
Measured: 4 Week After Treatment
Center of Pressure Standard Deviation
Center of pressure variability during quiet standing will be assessed using the ProKin 252 posturography system (TecnoBody, Italy). Standard deviation of CoP displacement will be recorded as an indicator of postural stability. Lower values indicate better postural control.
Measured: Before Treatment
Center of Pressure Standard Deviation
Center of pressure variability during quiet standing will be assessed using the ProKin 252 posturography system (TecnoBody, Italy). Standard deviation of CoP displacement will be recorded as an indicator of postural stability. Lower values indicate better postural control.
Measured: 4 Week After Treatment
Center of Pressure Ellipse Area
Static balance will be assessed using the ProKin 252 posturography system (TecnoBody, Italy). Center of pressure sway during quiet standing will be analyzed. Ellipse area (mm²) will be recorded as an indicator of postural stability. Lower values indicate better postural control.
Measured: Before Treatment
Center of Pressure Ellipse Area
Static balance will be assessed using the ProKin 252 posturography system (TecnoBody, Italy). Center of pressure sway during quiet standing will be analyzed. Ellipse area (mm²) will be recorded as an indicator of postural stability. Lower values indicate better postural control.
Measured: 4 Week After Treatment
Total Sway Perimeter
Static balance will be assessed using the ProKin 252 posturography system (TecnoBody, Italy). Center of pressure sway during quiet standing will be analyzed. Total sway perimeter (mm) will be recorded as an indicator of postural stability. Lower values indicate better postural control.
Measured: Before treatment
Total Sway Perimeter
Static balance will be assessed using the ProKin 252 posturography system (TecnoBody, Italy). Center of pressure sway during quiet standing will be analyzed. Total sway perimeter (mm) will be recorded as an indicator of postural stability. Lower values indicate better postural control.
Measured: 4 Week After Treatment
Dynamic Balance (Average Track Error)
Dynamic balance will be evaluated using the ProKin 252 platform-based proprioceptive control task. Movement accuracy will be quantified using average track error (%), representing the deviation from the target trajectory during the task. Lower values indicate better balance performance.
Measured: Before treatment
Dynamic Balance (Average Track Error)
Dynamic balance will be evaluated using the ProKin 252 platform-based proprioceptive control task. Movement accuracy will be quantified using average track error (%), representing the deviation from the target trajectory during the task. Lower values indicate better balance performance.
Measured: 4 Week After Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start15 Mar 2026
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yakup Erden, MD, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471919
- Sponsor's protocol ID
- AIBU-FTR-YE-01
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Filingeri V, Baroni B, Boffo V, Rosati R, Pisani F, Nardi S, Casciani CU. [Effects of cyclosporin on blood gastrin after kidney transplant]. Minerva Med. 1987 Jun 30;78(12):831-4. Italian.
PubMed 3299147Lu W, Wen M, Li Y, Liu F, Li Y, Zhang H, Zhang M. Effects of visual feedback balance system combined with weight loss training system on balance and walking ability in the early rehabilitation stage of stroke: a randomized controlled exploratory study. Ther Adv Neurol Disord. 2024 Sep 30;17:17562864241266512. doi: 10.1177/17562864241266512. eCollection 2024.
PubMed 39376636Gunduz MS, Mustafaoglu R, Ural IH. Effects of Robot-Assisted Gait Training on Balance and Fear of Falling in Patients With Stroke: A Randomized Controlled Clinical Trial. Am J Phys Med Rehabil. 2025 Jun 1;104(6):558-566. doi: 10.1097/PHM.0000000000002674. Epub 2024 Dec 3.
PubMed 39642346