Robot-assisted ankle-foot training with virtual reality for stroke rehabilitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this assessor-blinded, two-arm randomized trial, adults aged 40–65 with chronic stroke will be assigned to either robot-assisted foot-ankle training or conventional foot-ankle therapy. The intervention combines robot-assisted motor practice with a plantar tactile task and VR-supported joint position sense training to target sensory and proprioceptive function. Primary outcomes focus on sensorimotor and clinical gait and balance measures, with assessments conducted by blinded evaluators. The trial plans to enroll 30 participants to compare the structured, VR-integrated protocol against standard care.

Why it matters

Who can join: the full rules

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.

Where it's running

• İstanbul Medipol Üniversitesi-Acıbadem Medipol Region Hospital
  Istanbul, Istanbul, Turkey (Türkiye) Recruiting
• İstanbul Medipol Üniversitesi
  Istanbul, Turkey (Türkiye) Not yet recruiting

Study contacts

• Study coordinator: Esra TEKECİ, physiotherapist
• Email: esratekeci@gmail.com
• Phone: +905365870917

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.