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NCT05837975
Effect of the Exoskeleton for Assisting Ambulatory Activities in People With Subacute Stroke
NA trial testing FREE Walk Exoskeleton in Stroke in 2 participants. Completed in 15 March 2024.
15 March 2024
Quick facts
| Lead sponsor | Taipei Hospital, Ministry of Health and Welfare |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 5 July 2023 |
| Primary completion | 15 March 2024 |
| Estimated completion | 15 March 2024 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- FREE Walk Exoskeleton
- Traditional Rehabilitation
Conditions studied
- Stroke — all drugs for Stroke →
- Exoskeleton — all drugs for Exoskeleton →
Sponsor
Taipei Hospital, Ministry of Health and Welfare
Who can join
Eligibility, any sex, with Stroke or Exoskeleton. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Although rehabilitation activities, including physical therapy, are known to be beneficial for stroke patients, many patients still have poor walking function, especially after the acute phase of three months, where the recovery of lower limb walking ability through traditional rehabilitation therapy gradually decreases, requiring alternative approaches. Exoskeleton robots appear to provide benefits for stroke patients by providing exercise guidance, thus improving their independent gait endurance and stair climbing ability. For stroke patients who cannot continue to improve through general rehabilitation and have ongoing mobility difficulties, exoskeletons may be a potential solution. However, previous literature on the use of exoskeletons to assist gait training has had mixed results, with one major reason being that the frequency of use is too low or the duration of use is too short, due to the high cost and inconvenience of travel to medical institutions. Therefore, it is necessary to find ways to enable patients to use them frequently and for a long period. Method: investigators designed a non-blinded, randomized crossover trial to observe the potential benefits of using the device at home for one month. Patients were randomly divided into two groups, one receiving traditional rehabilitation first and the other using the exoskeleton first. There were four time points for testing: before, after the first stage of treatment, after the second stage of treatment, and one month after completing the second stage, to observe the sustained effects. The testing involved executing a 6-minute walk test, timed up and go test, and a 10-step stair test (up and down) both with and without the device. An electronic software app was used to record daily usage time to determine the quantity and degree of home use. Analysis: Repeated measures ANOVA models were used to analyze the effects and correlations of the experiment. The effects of the duration/frequency of use on dosage were also analyzed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05837975
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Stroke
Currently open trials in the same condition.
- NCT06615973 — Screening for Social Determinants of Health (SDOH) and Cognitive Function in Individuals With History of Stroke · recruiting
- NCT07494890 — Measurement Properties of Mechanical Cost of Walking for Individuals With Walking Impairment · NA · recruiting
- NCT07356011 — Exoskeleton for Balance · NA · recruiting
- NCT07523503 — Unilateral Versus Bilateral Task-specific Training on Motor Impairment, Upper Extremity Function, and Hand Dexterity in · NA · recruiting
- NCT06704074 — Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients · NA · recruiting
Other Taipei Hospital, Ministry of Health and Welfare trials
Trials by the same sponsor.
- NCT07398131 — Voice-Induced Motor Intention to Enhance Upper Limb Rehabilitation Efficacy of Exoskeleton Robots for Stroke Patients · NA · not yet recruiting
- NCT06232499 — Effects of Intravenous Laser Irradiation of Blood Treatment With Different Colored Lights on Controlling Recurrent Strok · NA · completed
- NCT06233305 — Effect of Physical Therapy and/or Platelet Rich Plasma Injection in People With Knee Cruciate Ligament Injuries · unknown
- NCT06192459 — Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotato · NA · unknown
- NCT06192433 — Repeated Transcranial Magnetic Stimulation in the Elderly With Cognitive Impairment · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05837975 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Taipei Hospital, Ministry of Health and Welfare
- Last refreshed: 20 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05837975.
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