NCT07250425Toborzás még nem indult
Development and Efficacy of a Novel, Cost-Effective Gait Training Device Utilized at Home for Stroke Survivors
Development of a Novel, Cost-Effective Gait Training Device Utilized at Home for the Neurological Patient Population
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. márc. 9.
Rövid összefoglaló (regiszter, angolul)
This pilot, parallel-group randomized controlled trial will evaluate the feasibility, safety, usability, and preliminary efficacy of the Rise\&Walk InHome (RWH), a novel robotic gait training device designed for home use after stroke. Twenty adults with lower-extremity motor impairment following a first-ever stroke (3 months to 5 years post-event) will be randomized 1:1 to either (1) RWH-assisted home walking plus usual care or (2) usual care alone for 12 weeks. Participants in the intervention group will receive an in-home RWH device, complete a structured device training program, and be instructed to perform 30-minute RWH walking sessions four times per week (48 sessions total). All participants will undergo standardized outcome assessments at baseline, weeks 4, 8, and 12, including the 6-Minute Walk Test (primary outcome), 10-Meter Walk Test, daily step count via wearable activity tracker, and health-related quality of life (SF-36). Additional feasibility and usability outcomes include device use and adherence, patient satisfaction and motivation, ease of use, perceived exertion, and adverse events. Findings will inform the feasibility of in-home deployment of the RWH device and provide preliminary effect-size estimates to guide the design of a larger efficacy trial.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 20 (tervezett)
- Első benyújtás
- 2025. máj. 28.
- Kezdés
- 2026. aug.
- Elsődleges befejezés
- 2026. aug.
- Fő szponzor
- Healing Innovations
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT07250425
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 20
- 2026. aug. és az elsődleges befejezés (2026. aug.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- Unstable cardiovascular, respiratory, or other medical conditions that contraindicate moderate- to high-intensity walking exercise (e.g., unstable angina, decompensated heart failure, uncontrolled arrhythmias).
- Severe musculoskeletal or orthopedic conditions limiting safe participation in supported stepping (e.g., unstable fractures, severe contractures preventing positioning in the device).
- Severe spasticity or movement disorders that would preclude safe use of the device, based on investigator judgment.
- Severe cognitive impairment, aphasia, or behavioral disturbance that would prevent informed consent or safe participation.
- Progressive neurological conditions (e.g., progressive neurodegenerative disease) expected to significantly worsen over the 12-week study period.
- Any other condition that, in the opinion of the investigators, would make participation unsafe or interfere with study adherence or outcome interpretation.
Egyéb
- Current participation in another interventional trial targeting gait or lower-extremity function.
Kiket keres a vizsgálat
- Age ≥ 18 years.
- First-ever ischemic or hemorrhagic stroke confirmed by medical record.
- 3 months to 5 years post-stroke at time of enrollment.
- Presence of lower-extremity motor impairment limiting walking function.
- Able to stand for at least 30 minutes with no more than minimal assistance (with or without a device).
- Medically stable and cleared by a physician to participate in moderate-intensity ambulation exercise.
- Living in a home environment that can safely accommodate device installation (e.g., adequate space, appropriate flooring, and power access) as determined by the study team.
- Able to understand study procedures and provide informed consent (or have a legally authorized representative), with sufficient cognitive and communication skills to follow simple instructions.
- If assistance is required for transfers or device set-up, availability of a caregiver or assistant willing to participate in training and device use.
Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Kessler Foundation | West Orange | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.