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| Name | Class |
|---|---|
| The Scientific and Technological Research Council of Turkey | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted training group (RTG) | Experimental | Robot-assisted ankle-foot sensorimotor training will consist of plantar vibrotactile sensory training, passive ROM training, VR-based joint position sense training, active ROM training using an assist-as-needed paradigm, and a final sensory training phase. Training will be delivered three times per week for six weeks, with progression individualized according to participant performance, ROM capacity, and safety limits. Difficulty will be increased by modifying sensory task complexity, repetitions, target positions, movement speed, and robotic assistance parameters. |
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| Manual Training Group (MTG) | Active Comparator | Participants in the manual training group will receive a structured ankle-foot sensorimotor training program delivered by a physiotherapist. The intervention will include plantar sensory training, passive ROM training, joint position sense training, active ROM training, and a final sensory training phase. Training will be provided three times per week for six weeks, with progression individualized according to participant performance, ROM capacity, and safety limits. Progression will be achieved by modifying sensory task difficulty, repetitions, target positions, movement speed, and exercise volume throughout the intervention period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-Assisted Foot-Ankle Training | Other | Stage 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to the end of the 6-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to the end of the 6-week intervention |
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The inclusion criteria are as follows:
The exclusion criteria are as follows:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esra TEKECÄ°, physiotherapist | Contact | +905365870917 | esratekeci@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İstanbul Medipol Üniversitesi-Acıbadem Medipol Region Hospital | Recruiting | Istanbul | Istanbul | 34815 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29049293 | Background | Kwong PWH, Ng SSM, Chung RCK, Ng GYF. A structural equation model of the relationship between muscle strength, balance performance, walking endurance and community integration in stroke survivors. PLoS One. 2017 Oct 19;12(10):e0185807. doi: 10.1371/journal.pone.0185807. eCollection 2017. | |
| 34563008 | Background |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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This is a randomized controlled trial with 1:1 allocation comparing structured robot-assisted ankle-foot training (Robot-assisted training group, RTG) with structured manual ankle-foot training delivered by a physiotherapist (Manual training group, MTG) in individuals with chronic stroke.
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This study will be single-blind. Outcome assessments will be performed by an experienced physiotherapist blinded to group allocation. Due to the nature of the interventions, participants and treating physiotherapists cannot be blinded.
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| Conventional Foot-Ankle Training | Other | Stage 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 |
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| 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. | From baseline to the end of the 6-week intervention |
| 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. | From baseline to the end of the 6-week intervention |
| 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. | From baseline to the end of the 6-week intervention |
| Tactile Perception Level (The Semmes-Weinstein Monofilament Test) | Tactile perception will be assessed using the The Semmes-Weinstein Monofilament Test. Five monofilaments will be applied to plantar (7 points) and dorsal (2 points) regions; analyses will use changes in the corresponding force (g) values. Participants will be supine with eyes closed. The monofilament will be applied perpendicular to the skin for ~1-1.5 s; three repetitions will be performed at each point and responses recorded verbally. | From baseline to the end of the 6-week intervention |
| Walking Capacity | Walking capacity will also be assessed using the 2-Minute Walk Test (2MWT) distance (m). Participants will walk for 120 s at a self-selected, comfortable, and safe pace. Customary walking aids may be used if needed, but no manual assistance will be provided. Rest breaks will be allowed; however, the timer will continue uninterrupted. The total distance covered will be recorded in meters. | From baseline to the end of the 6-week intervention |
| Motor Performance (The Fugl-Meyer Assessment for the Lower Extremity) | Motor performance will be assessed using the Fugl-Meyer Assessment for the Lower Extremity (FMA-LE). The FMA-LE evaluates hip, knee, and ankle motor function across reflex activity, synergies, selective movements, and coordination/speed. Items are scored 0-2 (total 0-34), with higher scores indicating better motor function. Assessments will be conducted in a standardized, quiet environment using standardized verbal instructions in supine, sitting, or standing positions as required by the test. | From baseline to the end of the 6-week intervention |
| Dynamic Balance Assessment 1 (TUG) | Dynamic balance and functional mobility will be assessed using the Timed Up and Go (TUG) test. The time (s) required to stand from a chair, walk 3 m, turn, return, and sit will be recorded. Participants may use their habitual walking aids if needed; no manual assistance will be provided. Three trials will be averaged. | From baseline to the end of the 6-week intervention |
| Modified Ashworth Scale (Tonus Assessment) | Muscle tone will be assessed using the Modified Ashworth Scale (MAS) for the quadriceps, hamstrings, adductors, and gastrosoleus. MAS scores range from 0 to 4 (including 1+), with lower scores indicating less spasticity: 0 (no increase in tone), 1 (slight increase in tone), 1+ (marked resistance through less than half of the ROM), 2 (increased tone through most of the ROM), 3 (considerable increase in tone making passive movement difficult), and 4 (rigidity). Assessments will be performed with a single, rapid passive movement through ROM with the participant relaxed. | From enrollment to the end of treatment at 6 week intervention |
| Assessment of Joint Range of Motion (Electrogoniometer) | Passive and active ankle ROM will be assessed using an electrogoniometer. Participants will be positioned on an examination plinth with the hip and knee flexed to 90°, tibiae perpendicular to the floor, and feet unsupported. Neutral ankle position will be defined as 0° (foot perpendicular to the tibia). For dorsiflexion-plantarflexion measurements, the axis will be aligned with the lateral malleolus, the proximal reference with the lateral midline of the fibula, and the distal reference with the lateral midline of the fifth metatarsal. The rearfoot will be stabilized to minimize inversion/eversion during testing. | From baseline to the end of the 6-week intervention |
| Dynamic Balance Assessment 2 (The Mini Balance Evaluation Systems Test) | The Mini Balance Evaluation Systems Test (Mini-BESTest) will assess dynamic balance across anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each of the 14 items is scored 0-2 (total 0-28), with higher scores indicating better balance. | From baseline to the end of the 6-week intervention |
| İstanbul Medipol Üniversitesi | Not yet recruiting | Istanbul | Turkey (Türkiye) |
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| Result | http://dx.doi.org/10.1016/j.jbmt.2017.04.013 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |