N/A
N=19
Smartphone and 3D Printing Based Home Rehabilitation System for Chronic Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT04363944 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Repetitions Completed for Each Activity in the mRehab Home Program — 282.06; NA; 289.44; NA repetitions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- mRehab (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Repetitions Completed for Each Activity in the mRehab Home Program |
282.06; NA; 289.44; NA; 283.69; NA | — |
| PRIMARY Time to Complete Activity in the mRehab Home Program |
4.03; 4.17; 4.01; 4.71; 5.22; 9.28 | <0.001 sig |
| PRIMARY Average Smoothness Per Activity in the mRehab Home Program |
410.66; 768.17; 375.39; 732.16; 492.70; 1869.6 | =.228 |
| SECONDARY Wolf Motor Function Test |
15.25; 96.27 | =.017 sig |
| SECONDARY Nine Hole Peg Test |
136.36; 300 | =.019 sig |
| SECONDARY Difficulty Rating Scale |
1.07 | — |
| SECONDARY Systems Usability Scale (SUS) |
31.25 | — |
| SECONDARY mRehab Acceptance Questionnaire |
91.56; 106 | — |
Summary
Interventions promoting optimum motor performance across the lifespan are a priority after a neurological insult such as stroke. The proposed research incorporates smart devices and 3D printing to create a patient-centered rehabilitation device, mRehab. This innovative blend of technology and principles of neuroplasticity can advance standards of practice in healthcare. In this feasibility study, it is hypothesized that individuals with chronic stroke can successfully use the portable rehabilitation unit, mRehab, at home with minimal oversight from the research team. Use of mRehab in a home based setting and functional changes in upper limb movement will be assessed.
Eligibility Criteria
Individuals in the intervention all had a history of stroke.
Inclusion Criteria for feasibility study:
- at least 18 years of age and living in the community
- had a history of one stroke six or more months previous
- had a minimum score of 124 on the Mattis Dementia Rating Scale (MDRS).
Exclusion Criteria for feasibility study:
- acute or chronic pain that would interfere with participation
- severely limited range of motion or contractures of shoulder, elbow, wrist or hand,
- absent or severely impaired proprioception of the upper limb
- musculoskeletal or circulatory conditions affecting the upper limb such as vascular disease, tendonitis, cellulitis, Raynaud's syndrome, or severe osteoarthritis or rheumatoid arthritis
- spasticity graded as 3 or greater for upper extremity movement on the Modified Ashworth Scale (MAS)
- botulinum toxin injections for spasticity management within three months of starting the study
Data sourced from ClinicalTrials.gov (NCT04363944). 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.