Effectiveness of Robot-Assisted Structured Foot-Ankle Sensorimotor Training in Stroke Patients

NCT07091045 | Recruiting DMC

• 1 other identifier: E-10840098-202.3.02-2627
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke

Keywords

stroke; rehabilitation medicine; virtual reality

Outcome Measures

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.

  From baseline to the end of the 6-week intervention

Secondary Outcomes (11)

• Static Balance Assessment (The Single-Leg Stance Test)

  From baseline to the end of the 6-week intervention

• Assessment of Joint Position Sense

  From baseline to the end of the 6-week intervention

• Assessment of Satisfaction Level Related to the Robot (Quest Scale-Lıkert Scale-4's)

  From baseline to the end of the 6-week intervention

• Quality of Life Assessment (The Stroke-Specific Quality of Life Scale)

  From baseline to the end of the 6-week intervention

• Tactile Perception Level (The Semmes-Weinstein Monofilament Test)

  From baseline to the end of the 6-week intervention

Study Arms (2)

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.

Other: Robot-Assisted Foot-Ankle Training

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.

Other: Conventional Foot-Ankle Training

Interventions

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

Also known as: Robotic foot-ankle therapy in stroke

Robot-assisted training group (RTG)

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

Manual Training Group (MTG)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Stroke ≥6 months prior to enrollment (chronic stroke),
• Ankle plantarflexor spasticity ≤2 on the Modified Ashworth Scale,
• Ankle dorsiflexor strength ≥ grade 2 on the Medical Research Council (MRC) scale,
• Passive ankle dorsiflexion to neutral (90°; 0°) without a plantarflexion contracture,
• Moderate or mild lower-extremity impairment based on the Fugl-Meyer Assessment-Lower Extremity (FMA-LE) score (21-27 moderate; 28-34 mild/good),
• Able to sit for at least 1 hour,
• Able to walk at least 10 meters with or without an assistive device,
• Completed all conventional lower-extremity physical therapy and rehabilitation programs.

You may not qualify if:

• 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,
• Sensory deficits such as hemisensory neglect,
• Acute musculoskeletal or cardiovascular disorders,
• Intrathecal baclofen pump use or botulinum toxin injections within the past 5 months,
• Fixed or painful contracture of the paretic ankle,
• Uncontrolled systemic diseases (e.g., diabetes, hypertension, debilitating or immunosuppressive diseases),
• history of a non-stroke neurological disease/disorder that may impair comprehension of instructions,
• Concurrent participation in other lower-extremity physical therapy, robotic rehabilitation, or neurological exercise programs.

Sponsors & Collaborators

• Medipol University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (2)

İstanbul Medipol Üniversitesi-Acıbadem Medipol Region Hospital

Istanbul, Istanbul, 34815, Turkey (Türkiye)

RECRUITING

İstanbul Medipol Üniversitesi

Istanbul, Turkey (Türkiye)

NOT YET RECRUITING

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  RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Esra TEKECİ, physiotherapist

CONTACT

+905365870917; esratekeci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 29, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

TU (2)