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StrokeNCT07091045

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

A study testing Robot-Assisted Foot-Ankle Training and Conventional Foot-Ankle Training in people with Stroke, run by Medipol University at 2 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Stroke
What is being tested?
Robot-Assisted Foot-Ankle Training and Conventional Foot-Ankle Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Mar 2026to 15 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

The inclusion criteria are as follows:

  1. Age 40-65 years,
  2. Able to understand and follow study instructions,
  3. Able to communicate coherently and oriented in time and place,
  4. Provided written informed consent,
  5. Stroke ≥6 months prior to enrollment (chronic stroke),
  6. Ankle plantarflexor spasticity ≤2 on the Modified Ashworth Scale,
  7. Ankle dorsiflexor strength ≥ grade 2 on the Medical Research Council (MRC) scale,
  8. Passive ankle dorsiflexion to neutral (90°; 0°) without a plantarflexion contracture,
  9. Moderate or mild lower-extremity impairment based on the Fugl-Meyer Assessment-Lower Extremity (FMA-LE) score (21-27 moderate; 28-34 mild/good),
  10. Able to sit for at least 1 hour,
  11. Able to walk at least 10 meters with or without an assistive device,
  12. Completed all conventional lower-extremity physical therapy and rehabilitation programs.

The exclusion criteria are as follows:

  1. Cognitive impairment (Mini-Mental State Test score ≤ 24),
  2. Conditions affecting walking or balance (e.g., orthopedic complications, lower extremity amputation, osteoporosis),
  3. Insufficient visual acuity to view a screen (e.g., diplopia),
  4. Severe visual deficits (e.g., hemianopia) or vestibular disorders34,
  5. Sensory deficits such as hemisensory neglect,
  6. Acute musculoskeletal or cardiovascular disorders,
  7. Intrathecal baclofen pump use or botulinum toxin injections within the past 5 months,
  8. Fixed or painful contracture of the paretic ankle,
  9. Uncontrolled systemic diseases (e.g., diabetes, hypertension, debilitating or immunosuppressive diseases),
  10. history of a non-stroke neurological disease/disorder that may impair comprehension of instructions,
  11. Concurrent participation in other lower-extremity physical therapy, robotic rehabilitation, or neurological exercise programs.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Esra TEKECİ, physiotherapist contact

+905365870917

esratekeci@gmail.com

Turkey (Türkiye)2 sites, 2 recruiting

  • İstanbul Medipol Üniversitesi-Acıbadem Medipol Region Hospital

    Istanbul, Istanbul, 34815

    GÖKHAN ÖZKOÇAK, physiotherapist, +905365870917, gokhan.ozkocak@medipol.edu.tr

    Esra TEKECİ, Physiotherapist

    Recruiting

  • İstanbul Medipol Üniversitesi

    Istanbul

    MEDİPOLU İSTANBUL MEDİPOL ÜNİVERSİTESİ, +902164448544

    Not yet recruiting

Other trials in Turkey (Türkiye)

About this study

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
Being tested
Robot-Assisted Foot-Ankle Training, Conventional Foot-Ankle Training
Keywords
stroke, rehabilitation medicine, virtual reality
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-Assisted Foot-Ankle TrainingOther

    Also called Robotic foot-ankle therapy in stroke

    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

  • Conventional Foot-Ankle TrainingOther

    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

Study groups in NCT07091045
Study groupRoleWhat they receive
Robot-assisted training group (RTG)ExperimentalRobot-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.
Receives: Other: Robot-Assisted Foot-Ankle Training
Manual Training Group (MTG)Active comparatorParticipants 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.
Receives: Other: Conventional Foot-Ankle Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to the end of the 6-week intervention

Secondary outcomes (11)

  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.

    Measured: From baseline to the end of the 6-week intervention

  2. 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.

    Measured: From baseline to the end of the 6-week intervention

  3. 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.

    Measured: From baseline to the end of the 6-week intervention

  4. 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.

    Measured: From baseline to the end of the 6-week intervention

  5. 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.

    Measured: From baseline to the end of the 6-week intervention

  6. 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.

    Measured: From baseline to the end of the 6-week intervention

  7. 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.

    Measured: From baseline to the end of the 6-week intervention

  8. 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.

    Measured: From baseline to the end of the 6-week intervention

  9. 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.

    Measured: From enrollment to the end of treatment at 6 week intervention

  10. 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.

    Measured: From baseline to the end of the 6-week intervention

  11. 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.

    Measured: From baseline to the end of the 6-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2025
  2. Study start1 Mar 2026
  3. Primary completion15 Feb 2027 (estimated)
  4. Study completion15 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07091045
Sponsor's protocol ID
E-10840098-202.3.02-2627
Status last verified
May 2026
First submitted
9 Jul 2025
Last updated
28 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 29049293

  • Kim KH, Jang SH. Effects of Cognitive Sensory Motor Training on Lower Extremity Muscle Strength and Balance in Post Stroke Patients: A Randomized Controlled Study. Clin Pract. 2021 Sep 14;11(3):640-649. doi: 10.3390/clinpract11030079.

    PubMed 34563008

  • Kim H, Cho S, Lee H. Effects of passive Bi-axial ankle stretching while walking on uneven terrains in older adults with chronic stroke. J Biomech. 2019 May 24;89:57-64. doi: 10.1016/j.jbiomech.2019.04.014. Epub 2019 Apr 17.

    PubMed 31060809

  • Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.

    PubMed 29740561

  • Kavounoudias A, Roll R, Roll JP. The plantar sole is a 'dynamometric map' for human balance control. Neuroreport. 1998 Oct 5;9(14):3247-52. doi: 10.1097/00001756-199810050-00021.

    PubMed 9831459

  • de la Iglesia DH, Mendes AS, Gonzalez GV, Jimenez-Bravo DM, de Paz Santana JF. Connected Elbow Exoskeleton System for Rehabilitation Training Based on Virtual Reality and Context-Aware. Sensors (Basel). 2020 Feb 6;20(3):858. doi: 10.3390/s20030858.

    PubMed 32041156

  • Hussain I, Jany R. Interpreting Stroke-Impaired Electromyography Patterns through Explainable Artificial Intelligence. Sensors (Basel). 2024 Feb 21;24(5):1392. doi: 10.3390/s24051392.

    PubMed 38474928

  • Hoh JE, Semrau JA. The Role of Sensory Impairments on Recovery and Rehabilitation After Stroke. Curr Neurol Neurosci Rep. 2025 Mar 6;25(1):22. doi: 10.1007/s11910-025-01407-9.

    PubMed 40047982

  • Hesse S, Tomelleri C, Bardeleben A, Werner C, Waldner A. Robot-assisted practice of gait and stair climbing in nonambulatory stroke patients. J Rehabil Res Dev. 2012;49(4):613-22. doi: 10.1682/jrrd.2011.08.0142.

    PubMed 22773263

  • GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

    PubMed 34487721

  • Forrester LW, Roy A, Krywonis A, Kehs G, Krebs HI, Macko RF. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2014 Sep;28(7):678-87. doi: 10.1177/1545968314521004. Epub 2014 Feb 10.

    PubMed 24515923

  • Foley N, Murie-Fernandez M, Speechley M, Salter K, Sequeira K, Teasell R. Does the treatment of spastic equinovarus deformity following stroke with botulinum toxin increase gait velocity? A systematic review and meta-analysis. Eur J Neurol. 2010 Dec;17(12):1419-27. doi: 10.1111/j.1468-1331.2010.03084.x.

    PubMed 20491885

  • Ferry B, Compagnat M, Yonneau J, Bensoussan L, Moucheboeuf G, Muller F, Laborde B, Jossart A, David R, Magne J, Marais L, Daviet JC. Awakening the control of the ankle dorsiflexors in the post-stroke hemiplegic subject to improve walking activity and social participation: the WAKE (Walking Ankle isoKinetic Exercise) randomised, controlled trial. Trials. 2022 Aug 16;23(1):661. doi: 10.1186/s13063-022-06545-w.

    PubMed 35974379

  • Feigin VL, Brainin M, Norrving B, Martins S, Sacco RL, Hacke W, Fisher M, Pandian J, Lindsay P. World Stroke Organization (WSO): Global Stroke Fact Sheet 2022. Int J Stroke. 2022 Jan;17(1):18-29. doi: 10.1177/17474930211065917.

    PubMed 34986727

  • De Santis D, Zenzeri J, Casadio M, Masia L, Riva A, Morasso P, Squeri V. Robot-assisted training of the kinesthetic sense: enhancing proprioception after stroke. Front Hum Neurosci. 2015 Jan 5;8:1037. doi: 10.3389/fnhum.2014.01037. eCollection 2014.

    PubMed 25601833

Questions about this trial

What is this clinical trial studying?

A study testing Robot-Assisted Foot-Ankle Training and Conventional Foot-Ankle Training in people with Stroke, run by Medipol University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Esra TEKECİ, physiotherapist (+905365870917, esratekeci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Walking Speed (10-Meter Walk Test) (time frame: From baseline to the end of the 6-week intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07091045, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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