Robotic Assisted Task-Oriented Rehabilitation of Upper Limb for Chronic Stroke Patients
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Change in Fugl-Meyer Assessment (FMA( Score
Study Overview
Brief Summary
The aim of this study is to evaluate the effects of an assisted rehabilitation treatment through a robotic exoskeleton device on the functional recovery in a group of patients with hemiparesis from lesion of the first motor neuron (post-stroke), compared with a group of patients subjected to a conventional rehabilitation treatment. The patients enrolled in the study are chronic stroke injured with right hemiparesis of moderate to severe degree, by the system injury pyramid, never undergoing rehabilitation treatment with robots.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosis of a first-ever left hemisphere ischemic or hemorrhagic stroke at least 6 months prior to entry into the study;
- •minimum ability for shoulder humeral elevation;
- •upper-extremity motor function Fugl-Meyer (FM) score ≥ 15(out of 66);
- •absence of neurological or muscular disorders that interfere with neuromuscular function;
- •absence of severe cognitive deficits that would limit patients' ability to complete the study;
- •minimum score of 2 in the Modified Ashworth Scale;
- •not participating in any experimental rehabilitation or drug studies at the same time
- •no previous experience with robotic treatments.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Fugl-Meyer Assessment (FMA( Score
Time Frame: baseline and 6 weeks
The null hypothesis tested in this study was the change in motor function domain of the upper extremity portion of the Fugl-Meyer assessment in the Robotic Group (Robotic Treatment) would be the same as the one obtained by the Control Group (Conventional Treatment). The FMA outcome is further divided and analyzed in terms of sub-items. In particular, the motor FMA score is divided into proximal (shoulder and elbow movement, 36 points) and distal (hand and wrist movement, 24 points) sub-items.
Secondary Outcomes
- Functional scale: Bimanual Activity Test (BAT)(baseline and 6 weeks)
- Modified Ashworth (MA) scale(baseline and 6 weeks)
- Robotic kinesiological assessment of movement: Execution Time(At end of each session, during 6 weeks of enrollment in treatment)
- Robotic kinesiological assessment of movement: Smoothness index(At end of each session, during 6 weeks of enrollment in treatment)
Investigators
Antonio Frisoli
Prof, Office of Research and Development
Scuola Superiore Sant'Anna di Pisa