Phase 4
N=99
Rehabilitation of the Stroke Hand at Home
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01144715 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Action Research Arm Test (ARAT) — 39.47; 39.89 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hand Mentor (TM) robotic stroke therapy device (Device); Home Therapy Program (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Kinetic Muscles
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Action Research Arm Test (ARAT) |
39.47; 39.89 | — |
| SECONDARY Wolf Motor Function Test |
8.67; 7.92 | — |
| SECONDARY Fugl-Meyer Upper Extremity Test |
43.43; 42.89 | — |
| SECONDARY Stroke Impact Scale (SIS) |
49.4; 57.6 | — |
Summary
The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.
Eligibility Criteria
Inclusion Criteria
- Unilateral ischemic or hemorrhagic stroke
- within 6 months of admission to in-patient rehabilitation
- Persistent hemiparesis
- Proximal Upper Extremity voluntary activity
- Preserved cognitive function
- Difficult access to an organized stroke rehabilitation program
Exclusion Criteria
- Not independent before stroke
- Hemispatial neglect
- Significant other illnesses
Data sourced from ClinicalTrials.gov (NCT01144715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.