N/A
Completed N=12
MyHand: An Active Hand Orthosis for Stroke Patients
Source: ClinicalTrials.gov NCT03767894 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Score on Action Research Arm Test (ARAT) — 13.46; 14.82; 13.09 score on a scale — p=0.24
Summary
This study seeks to explore the efficacy of several control mechanisms for the device and the impact of a device training program on its utility as a neuroprosthetic and training tool for upper limb recovery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on Action Research Arm Test (ARAT) |
13.46; 14.82; 13.09 | 0.24 |
| PRIMARY Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM) |
25.36; 28 | 0.026 sig |
| SECONDARY Score on Modified Ashworth Scale (MAS) |
1; 1; 1; 0; 2; 0 | — |
| SECONDARY Score on Box and Blocks Test (BBT) |
47; 35; 24 | 0.442 |
| SECONDARY Number of Participants Completing Treatment Protocol |
11 | — |
| SECONDARY Total Number of Adverse Events During Intervention |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects over 18 years of age
- History of stroke resulting in significant upper limb impairment
- Full passive range of motion
- Gross control of the proximal upper extremity
- Lacks timely grasp/release
- No more than moderate flexor tone
- Intact cognition
Exclusion criteria include:
- Other Neurological/orthopedic disorders
- Excessive spasticity/contracture
Data sourced from ClinicalTrials.gov (NCT03767894). 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. Informational only — not medical advice.