N/A N=12 Treatment

MyHand: An Active Hand Orthosis for Stroke Patients

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT03767894 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Score on Action Research Arm Test (ARAT) — 13.46; 14.82; 13.09 score on a scale — p=0.24

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EMG Band (Device); Shoulder harness (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Columbia University
Primary completion: Jun 2019

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	—	—

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.

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

View full record on ClinicalTrials.gov →

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.