Comparing robotic therapy approaches for stroke rehabilitation
Effects of Proximal Priority Versus Distal Priority Robotic Priming Technique With Rehabilitation Therapy of Upper-Limb Functions in Patients With Chronic Stroke
This study is testing two different robotic therapy methods to see which one helps people with chronic stroke improve their arm movement and feeling better after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 4 sites (Taipei, Taipei and 3 other locations) |
| Trial ID | NCT04446273 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of two different robotic therapy approaches, proximal priority and distal priority, on upper extremity rehabilitation in patients with chronic stroke. A total of 54-72 participants will be randomly assigned to either the proximal or distal priority group and will undergo 18 sessions of robotic therapy over six weeks. The study will assess motor function and sensory abilities using established scales before, after treatment, and at a three-month follow-up. Statistical analyses will be conducted to compare the efficacy of the two approaches and identify predictors of outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 75 who have experienced a first unilateral stroke more than three months prior and have moderate to severe upper extremity motor impairment.
Not a fit: Patients with other neurological or orthopedic conditions, severe spasticity, or those unable to follow instructions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation strategies for stroke patients, leading to improved motor function and quality of life.
How similar studies have performed: While the concept of prioritizing proximal versus distal rehabilitation is recognized in practice, this specific comparative approach has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The inclusion criteria are age between 20 and 75 years old, more than 3 months after the onset of a first unilateral ischemic or hemorrhagic stroke, moderate to severe UE motor impairment (i.e., total UE score of the Fugl-Meyer Assessment \[FMA\] score between 18 and 56), no severe spasticity in any joints of the affected arm (modified Ashworth Scale score \<3 in any of the affected shoulder, elbow, wrist, and fingers), able to follow instructions (Mini-Mental State Examination total score \>24), no UE fractures in the past 3 months, and not simultaneously participating in other medication or rehabilitation studies. Exclusion Criteria: * The exclusion criteria are other neurologic, neuromuscular, or orthopedic disease, such as epilepsy, or severe health or physical conditions that might impede participation in this study.
Where this trial is running
Taipei, Taipei and 3 other locations
- National Taiwan University Hospital — Taipei, Taipei, Taiwan (Recruiting)
- Taipei Tzu Chi Hospital — New Taipei City, Taiwan (Recruiting)
- Fongyuan Hospital — Taichung, Taiwan (Recruiting)
- Taipei Municipal Wan Fang Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Keh-chung Lin, ScD — National Taiwan University
- Study coordinator: Kehchung Lin, ScD
- Email: kehchunglin@ntu.edu.tw
- Phone: +886233668180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.