N/A
N=12
Portable EMG-triggered Hand Robot for Individuals After Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02364700 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Fugl-Meyer Assessment of Upper Extremity (FMA) — 22.50 units on a scale — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hand of Hope (HOH) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rehab-Robotics Company Limited
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Assessment of Upper Extremity (FMA) |
22.50 | <.05 sig |
| PRIMARY Arm Motor Ability Test (AMAT) |
2.35 | — |
| PRIMARY Box and Blocks |
6.08 | — |
| SECONDARY Stroke Upper Limb Capacity Scale (SULCS) |
5.17 | — |
| SECONDARY Hand Dynamometry |
8.23 | — |
| SECONDARY Stroke Impact Scale --Hand Sub Scale (SIS-H) |
13.33 | — |
Summary
This is an interventional pilot study investigating the feasibility of using the hand of hope (HOH) device for individuals with decreased hand function after stroke.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of stroke > 6 months ago
- Presence of some active range of motion (AROM) in the affected hand, measured by a score of at least 1 on the Box and Block test.
- Intact sensation in the affected hand
- Full passive range of motion (PROM) in mass flexion and extension of the hand
- MAS score < 3 for finger flexors and intrinsics
- MAS score < 3 for finger extensors
- Visual tracking is intact in all directions
- Patient must be otherwise medically stable in the opinion of the principal investigator
Exclusion Criteria
- Patient is receiving active occupational or physical therapy for the affected arm
- Patient has joint contractures that prevent proper fit into the HOH device
- Patient has other concurrent neurological or orthopedic diagnoses that affect motor ability of the arm such as Parkinson's or Multiple Sclerosis, or arthritis
- It has been less than 3 months since last botulinum toxin injection in the affected arm
Data sourced from ClinicalTrials.gov (NCT02364700). 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.