Effectiveness of Robot-Assisted Structured Foot-Ankle Sensorimotor Training in Stroke Patients
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorMedipol University
About this trial
Introduction: Stroke is a leading cause of long-term disability worldwide. Persistent lower-extremity motor and somatosensory impairments after stroke commonly limit walking and balance despite rehabilitation. Virtual reality (VR)-integrated robotic rehabilitation may support structured, goal-directed ankle-foot practice; however, there is limited evidence for ankle-foot-focused sensorimotor protocols. In particular, approaches that combine robot-assisted motor training with a plantar tactile localization task and VR-supported joint position sense (JPS) training to target plantar sensory and proprioceptive function are scarce. Therefore, this study aims to evaluate the effectiveness of a structured, VR-integrated, robot-assisted ankle-foot sensorimotor rehabilitation protocol in individuals with chronic stroke and to examine its effects on clinical and sensorimotor outcomes.
Methods and analysis: This is an assessor-blinded, two-arm, parallel-group randomized controlled trial. Thirty individuals with chronic stroke will be randomized 1:1 to the Robot-assisted Training Group (RTG) or the Manual Training Group (MTG). All participants will receive conventional rehabilitation; in addition, RTG will receive a structured robot-assisted ankle-foot training program integrated with virtual reality and assist-as-needed control, whereas MTG will receive the same structured ankle-foot training protocol delivered manually by a physiotherapist. Interventions will be delivered three times per week for 6 weeks (18 sessions), and total session duration will be time-matched between groups (50-60 min per session). The primary outcome will be the change in walking speed, derived from the 10-Meter Walk Test, from baseline to 6 weeks. Secondary outcomes will include 2-Minute Walk Test distance, ankle range of motion, joint position sense, plantar tactile sensation, muscle tone, motor performance, static and dynamic balance, and stroke-specific quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 40-65 years,
Able to understand and follow study instructions,
Able to communicate coherently and oriented in time and place,
Provided written informed consent,
Disqualifiers
Cognitive impairment (Mini-Mental State Test score ≤ 24),
Conditions affecting walking or balance (e.g., orthopedic complications, lower extremity amputation, osteoporosis),
Insufficient visual acuity to view a screen (e.g., diplopia),
Severe visual deficits (e.g., hemianopia) or vestibular disorders34,
Trial design
Design model
Parallel
Treatments tested in this trial
Robot-Assisted Foot-Ankle Training
Other interventionStage 1: Vibration Training Applied for Proper Stepping on the Sole of the Foot and Proper Pressure Distribution: The first step of the training will be constant vibration, and the second step will be sensory localization training with vibration. Stage 2: Passive Joint Range of Motion Training with Virtual Reality: The platform will move the ankle passively (passive stretching). Stage 3: Joint Position Sense Training: The platform will bring the patient's ankle to a certain dorsiflexion position, the patient will be asked to feel and be aware of this angle, then the patient will be asked to return to the neutral position and perform ankle dorsiflexion at the angle that the platform initially brought. Stage 4: Active Joint Range of Motion Training with Virtual Reality: Along with active dorsiflexion, when necessary, assistance will be provided with the Assistance as Needed (AAN) control paradigm, a feature of the robotic device. Stage 5: It is the same as Stage 1
Conventional Foot-Ankle Training
Other interventionStage 1: Sensory Training to the Sole of the Foot: In the first step of the training, the physiotherapist will manually apply constant pressure with a blunt object, and in the second step, sensory localization training with a blunt object will be performed. Stage 2: Passive Joint Range of Motion Training: The ankle will be manually moved passively (passive stretching) by the physiotherapist. Stage 3: Joint Position Sense Training: The physiotherapist will bring the patient's ankle to a certain dorsiflexion position, the patient will be asked to feel and be aware of this angle, then the patient will be asked to return to the neutral position and perform ankle dorsiflexion at the angle that the physiotherapist initially brought. Stage 4: Active Joint Range of Motion Training: This stage will be performed with manual assistance provided by the physiotherapist when necessary, along with active dorsiflexion. Stage 5: It is the same as Stage 1
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Robot-assisted training group (RTG)Experimental treatment 1 intervention
Group B: Manual Training Group (MTG)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Walking Speed (10-Meter Walk Test)
Walking speed will be assessed using the 10-Meter Walk Test (10MWT). The test will be performed on a 14-m flat, unobstructed walkway including 2-m acceleration and 2-m deceleration distances. Time (s) will be recorded between 2 and 12 m using a stopwatch (dynamic start method), and walking speed (m/s) will be calculated as 10 m divided by the recorded time. Participants may use their customary walking aids. The test will be performed three times, and the mean walking speed will be used for analysis.
Time frame
From baseline to the end of the 6-week interventionSecondary outcomes
1
Static Balance Assessment (The Single-Leg Stance Test)
The test will be performed separately for each limb; three trials will be recorded per limb and averaged (s). Testing will occur on a flat, non-slip surface in a safe and quiet environment. Timing will start when the foot is fully lifted and stop when balance is lost, the foot touches down, or support is used.
Time frame
From baseline to the end of the 6-week intervention2
Assessment of Joint Position Sense
Ankle joint position sense (JPS) accuracy will be assessed using a standardized electrogoniometer-based protocol. Participants will identify previously presented ankle dorsiflexion target positions while visual input is eliminated. JPS accuracy will be quantified as the absolute error (AE) between the target angle and the perceived angle, with lower values indicating better proprioceptive performance. Measurements will be obtained from repeated trials and averaged to generate a total AE score.
Time frame
From baseline to the end of the 6-week intervention3
Assessment of Satisfaction Level Related to the Robot (Quest Scale-Lıkert Scale-4's)
Assessment of satisfaction with the robot: This will be assessed using a Quest-Likert scale. A 4-point Likert scale will be used for assessment. It is a survey methodology using four response options. Stroke patients express their level of satisfaction by selecting one of four options: 1 Strongly Disagree, 2 Disagree, 3 Agree, and 4 Strongly Agree. A higher score will be interpreted as increased satisfaction and positive patient progress.
Time frame
From baseline to the end of the 6-week intervention4
Quality of Life Assessment (The Stroke-Specific Quality of Life Scale)
The Stroke-Specific Quality of Life Scale (SS-QOL) will be used to assess quality of life. The SS-QOL is a valid and reliable instrument comprising 12 domains and 49 items, covering the physical, functional, and psychosocial aspects of individuals after stroke. Assessments will be conducted in a quiet environment based on participants' self-reports, with items scored using a 5-point Likert scale. Total scores range from 49 to 245, with higher scores indicating better quality of life. The scale will be administered before and after the intervention, and changes in total and/or subscale scores will be used for analysis.
Time frame
From baseline to the end of the 6-week interventionSponsors and contacts
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Medipol University
Lead sponsor
The Scientific and Technological Research Council of Turkey
Collaborator
Source ClinicalTrials.gov