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

N/ARecruitingNCT07471919

Abant Izzet Baysal University60 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Interventions

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 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 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 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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Before Treatment

Berg Balance Scale