NCT07091045Toboroz
Effectiveness of Robot-Assisted Structured Foot-Ankle Sensorimotor Training in Stroke Patients
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 28.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tervezett)
- Első benyújtás
- 2025. júl. 9.
- Kezdés
- 2026. márc. 1.
- Elsődleges befejezés
- 2027. febr. 15.
- Fő szponzor
- Medipol University
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT07091045
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 30
- 2026. márc. 1. és az elsődleges befejezés (2027. febr. 15.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
A regiszterben nem jelölt feltételek
- The inclusion criteria are as follows:
- 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.
- The exclusion criteria are as follows:
- 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.
Életkor a regiszterben: 40 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| İstanbul Medipol Üniversitesi-Acıbadem Medipol Region Hospital | Istanbul | Törökország | Toboroz |
| Istanbul Medipol Universitesi | Istanbul | Törökország | Toborzás még nem indult |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.