Robot-Assisted Gait Training vs Visual Feedback Balance Training in Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorAbant Izzet Baysal University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Unstable cardiopulmonary conditions
Severe musculoskeletal disorders affecting standing or walking
Severe aphasia preventing participation in assessments
Severe visual impairment interfering with balance testing
Trial design
Design model
Parallel
Treatments tested in this trial
Robot-Assisted Gait Training
DeviceRobot-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 Training
DeviceVisual 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Robot-Assisted Gait Training GroupActive comparator 1 intervention
Group B: Visual Feedback Balance Training GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 Treatment2
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
4 Week After TreatmentSecondary outcomes
1
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.
Time frame
Before Treatment2
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.
Time frame
4 Week After Treatment3
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.
Time frame
Before Treatment4
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.
Time frame
4 Week After TreatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov