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Recruiting NCT07471919

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

No phase Interventional Stroke Gait Impairment Balance Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robot-Assisted Gait Training, Visual Feedback Balance Training.
Who it may be relevant to
Registry conditions: Stroke, Gait Impairment, Balance Impairment. Basic parameters: 21 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Device Robot-Assisted Gait Training
    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 st
  • Device Visual Feedback Balance Training
    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 Participant

Primary outcome measures

  • Berg Balance Scale [Time frame: Before Treatment]
  • Berg Balance Scale [Time frame: 4 Week After Treatment]
Secondary outcome measures (12)
  • Timed Up and Go Test [Time frame: Before Treatment]
  • Timed Up and Go Test [Time frame: 4 Week After Treatment]
  • 10-Meter Walk Test [Time frame: Before Treatment]
  • 10-Meter Walk Test [Time frame: 4 Week After Treatment]
  • Fugl-Meyer Assessment - Lower Extremity [Time frame: Before Treatment]
  • Fugl-Meyer Assessment - Lower Extremity [Time frame: 4 Week After Treatment]
  • Barthel Index [Time frame: Before Treatment]
  • Barthel Index [Time frame: 4 Week After Treatment]
  • Falls Efficacy Scale - International [Time frame: Before Treatment]
  • Falls Efficacy Scale-International [Time frame: 4 Week After Treatment]
  • Functional Ambulation Category [Time frame: Before Treatment]
  • Functional Ambulation Category [Time frame: 4 Week After Treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • AIBU Izzet Baysak Physical Treatment and Rehabilitation Hospital — Bolu

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. PMID 3299147
  • Lu 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. PMID 39376636
  • Gunduz 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. PMID 39642346

Identifiers

NCT: NCT07471919 · AIBU-FTR-YE-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗