Glove Rehabilitation Application for Stroke Patients
Occupational Therapy · Virtual Reality
Bottom Line
View on ClinicalTrials.gov: NCT03872466 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GRASP HEP (Device); Usual Care Treatment (UCT) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Barron Associates, Inc.
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE) |
42.22; 42.44 | — |
| PRIMARY Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE) |
52.33; 44.00 | — |
| SECONDARY Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA) |
2.70; 2.67 | — |
| SECONDARY Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA) |
3.42; 2.84 | — |
| SECONDARY Pre Intervention Wolf Motor Function Test Time (WMFT-TIME) |
8.52; 11.01 | — |
| SECONDARY Post Intervention Wolf Motor Function Test Time (WMFT-TIME) |
6.97; 7.46 | — |
| SECONDARY Pre Intervention Box and Blocks Test (BBT) |
22.89; 12.78 | — |
| SECONDARY Post Intervention Box and Blocks Test (BBT) |
28.44; 14.44 | — |
| SECONDARY Pre Intervention Motor Activity Log - Amount (MAL-Amount) |
1.33; 1.30 | — |
| SECONDARY Post Intervention Motor Activity Log - Amount (MAL-Amount) |
2.55; 1.18 | — |
| SECONDARY Pre Intervention Motor Activity Log - How Well (MAL-How Well) |
1.35; 1.18 | — |
| SECONDARY Post Intervention Motor Activity Log - How Well (MAL-How Well) |
2.70; 1.20 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Participant has had a right or left hemispheric stroke affecting normal hand function;
- Participant has sufficient active finger flexion at the MCP joint in at least one finger to be detected by visual observation by a study therapist;
- Participant has visual acuity with corrective lenses of 20/50 or better;
- Participant's affected hand fits within sizing available for the glove orthosis;
- Participant is no longer in an active UE rehabilitation program; and
- Participant is currently living at a private residence and anticipates remaining at that location for the duration of study participation.
Exclusion Criteria
- Withholding or withdrawal of consent by the participant;
- Inability to understand and follow verbal directions;
- Determination by the Principal Investigator that participation would result in overexertion or significant discomfort or pain;
(3) A psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation (Principal Investigator will consult with candidate's personal physician as appropriate); (4) Determination by the Principal Investigator that participation would result in significant agitation or elevated stress; (5) Visual field deficit in either eye that impairs the ability to view the computer monitor; (6) Stiffness or contractures of the muscles, joints, tendons, ligaments, or skin that restricts normal movement; (7) More than mild tone/spasticity (measured on modified Ashworth, 5-point scale); (8) Severe contractures or joint deformities in the fingers; (9) Open wound or infection, severe edema, or excessive swelling which might interfere with wearing the glove; (10) Severe pre-stroke co-morbidities, such as cardiovascular, neurological, orthopedic, or rheumatoid impairments before stroke that may interfere with task performance; (11) Severe sensory deficits from the involved UE; or (12) Hemispatial neglect that impairs the ability to process and perceive visual stimuli provided through the computer monitor.
Data sourced from ClinicalTrials.gov (NCT03872466). 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.