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NCT Number: NCT07471919

Robot-Assisted Gait Training vs Visual Feedback Balance Training in 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.

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Key information

Conditions

Stroke Balance Impairment Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Impairment Nervous System Diseases Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AIBU Izzet Baysak Physical Treatment and Rehabilitation Hospital

Bolu, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yakup ERDEN, MD

CONTACT

[email protected]

+905556692721

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Unstable cardiopulmonary conditions
  • Severe musculoskeletal disorders affecting standing or walking
  • Severe aphasia preventing participation in assessments
  • Severe visual impairment interfering with balance testing

Treatment and study plan

Robot-assisted gait training

Device

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 Participants will receive conventional rehabilitation on the remaining days of the week. 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 Training

Device

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 Participants will receive conventional rehabilitation on the remaining days of the week. 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.

Primary outcomes

  1. Berg Balance Scale

    Time frame: Before Treatment

    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.

  2. Berg Balance Scale

    Time frame: 4 Week After Treatment

    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.

Secondary outcomes

  1. Timed Up and Go Test

    Time frame: Before Treatment

    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.

  2. Timed Up and Go Test

    Time frame: 4 Week After Treatment

    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.

  3. 10-Meter Walk Test

    Time frame: Before Treatment

    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.

  4. 10-Meter Walk Test

    Time frame: 4 Week After Treatment

    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.

  5. Fugl-Meyer Assessment - Lower Extremity

    Time frame: Before Treatment

    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.

  6. Fugl-Meyer Assessment - Lower Extremity

    Time frame: 4 Week After Treatment

    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.

  7. Barthel Index

    Time frame: Before Treatment

    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.

  8. Barthel Index

    Time frame: 4 Week After Treatment

    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.

  9. Falls Efficacy Scale - International

    Time frame: Before Treatment

    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.

  10. Falls Efficacy Scale-International

    Time frame: 4 Week After Treatment

    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.

  11. Functional Ambulation Category

    Time frame: Before Treatment

    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.

  12. Functional Ambulation Category

    Time frame: 4 Week After Treatment

    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.

  13. Center of Pressure Standard Deviation

    Time frame: Before Treatment

    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.

  14. Center of Pressure Standard Deviation

    Time frame: 4 Week After Treatment

    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.

  15. Center of Pressure Ellipse Area

    Time frame: Before Treatment

    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.

  16. Center of Pressure Ellipse Area

    Time frame: 4 Week After Treatment

    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.

  17. Total Sway Perimeter

    Time frame: Before treatment

    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.

  18. Total Sway Perimeter

    Time frame: 4 Week After Treatment

    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.

  19. Dynamic Balance (Average Track Error)

    Time frame: Before treatment

    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.

  20. Dynamic Balance (Average Track Error)

    Time frame: 4 Week After Treatment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet Burak Mavuş, MSc

CONTACT

+905388178351

Yakup ERDEN, MD

CONTACT

[email protected]

+905556692721

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

Comparison of Robot-Assisted Gait Training and Visual Feedback Balance Training on Balance and Gait Outcomes in Patients With Stroke

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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