Robot-Assisted Gait Training vs Visual Feedback Balance Training in Stroke
Comparison of Robot-Assisted Gait Training and Visual Feedback Balance Training on Balance and Gait Outcomes in Patients With Stroke
1 other identifier
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Mar 2026
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 13, 2026
CompletedStudy Start
First participant enrolled
March 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2026
March 18, 2026
March 1, 2026
5 months
March 10, 2026
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
4 Week After Treatment
Secondary Outcomes (20)
Timed Up and Go Test
Before Treatment
Timed Up and Go Test
4 Week After Treatment
10-Meter Walk Test
Before Treatment
10-Meter Walk Test
4 Week After Treatment
Fugl-Meyer Assessment - Lower Extremity
Before Treatment
- +15 more secondary outcomes
Study Arms (2)
Robot-Assisted Gait Training Group
ACTIVE COMPARATORRobot-Assisted Gait Training Conventional Rehabilitation Program
Visual Feedback Balance Training Group
ACTIVE COMPARATORVisual Feedback Balance Training Conventional Rehabilitation Program
Interventions
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 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 Criteria
You may qualify if:
- 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
You may not qualify if:
- Unstable cardiopulmonary conditions
- Severe musculoskeletal disorders affecting standing or walking
- Severe aphasia preventing participation in assessments
- Severe visual impairment interfering with balance testing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AIBU Izzet Baysak Physical Treatment and Rehabilitation Hospital
Bolu, Turkey (Türkiye)
Related Publications (3)
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: 3299147BACKGROUNDLu 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: 39376636BACKGROUNDGunduz 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: 39642346BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 10, 2026
First Posted
March 13, 2026
Study Start
March 15, 2026
Primary Completion (Estimated)
August 15, 2026
Study Completion (Estimated)
August 15, 2026
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share