NCT03767894

MyHand: An Active Hand Orthosis for Stroke Patients

Completed NA Results posted Last updated 5 November 2020

What this trial tests

NA trial testing EMG Band in Stroke in 12 participants. Completed in 27 June 2019.

Timeline

13 November 2017

Primary endpoint
27 June 2019

27 June 2019

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	13 November 2017
Primary completion	27 June 2019
Estimated completion	27 June 2019
Sites	1 location across United States

Drugs / interventions tested

• EMG Band
• Shoulder harness

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Columbia University

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Score on Action Research Arm Test (ARAT) Primary · Baseline; Post-test at Week 4

The ARAT is a 19-item measure that assesses upper limb functioning. The ARAT is divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from 0 (cannot perform) to 3 (normal performance). Scores on the ARAT range from 0-57 points, with higher scores indicating better performance.

Baseline

Group	Value	95% CI
MyHand Orthosis	13.46	± 2.184

Post Unassisted (week 4)

Group	Value	95% CI
MyHand Orthosis	14.82	± 2.148

Post Assisted (week 4)

Group	Value	95% CI
MyHand Orthosis	13.09	± 1.43

Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM) Primary · Baseline; Post-test at Week 4

The Fugl-Meyer (FM) Assessment of Motor Recovery evaluates and measures recovery in post-stroke hemiplegic patients. The FM uses a 3-point ordinal scale from 0 (cannot perform) to 2 (performs fully). The FM has 5 domains with a maximum score of 226 points. Subscales can be administered with out using the full FM. The Upper Extremity component (UEFM) consists of 33 items with a score range of 0-66. Higher score indicate better performance. Please note: An a prior decision was made to only perform the UEFM once at post-testing: post test without robotic assistance. The UEFM assesses capacity of

Baseline

Group	Value	95% CI
MyHand Orthosis	25.36	± 1.521

Post Unassisted (week 4)

Group	Value	95% CI
MyHand Orthosis	28	± 1.854

Score on Modified Ashworth Scale (MAS) Secondary · Baseline

The Ashworth or Modified Ashworth Scale (MAS) is a measure of spasticity originally developed as a simple clinical classification to assess the anti-spastic effects of carisoprodol in multiple sclerosis. It is rated on a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 (no increases in tone) to 4 (limb rigid in flexion/extension or abduction/adduction). Please note: MAS is officially scored on a 5-point scale that includes "1+" (full range: 0, 1, 1+, 2, 3, 4). However non-numeric scores are not allowable in the Outcome Measure Data Table. Therefore, the score

Elbow Flexors (baseline)

Group	Value	95% CI
MyHand Orthosis	1	0 – 5

Elbow Extensors (baseline)

Group	Value	95% CI
MyHand Orthosis	1	0 – 5

Wrist Flexors (baseline)

Group	Value	95% CI
MyHand Orthosis	1	0 – 5

Wrist Extensors (baseline)

Group	Value	95% CI
MyHand Orthosis	0	0 – 5

Finger Flexors (baseline)

Group	Value	95% CI
MyHand Orthosis	2	0 – 5

Finger Extensors (baseline)

Group	Value	95% CI
MyHand Orthosis	0	0 – 5

Score on Box and Blocks Test (BBT) Secondary · Baseline; Post-test at Week 4

The BBT measures unilateral gross manual dexterity using blocks and a 2-compartment box. At the start, there are 150 blocks in one compartment and the score represents the number of blocks transferred from one compartment to the other compartment in 60 seconds. Each hand is scored separately, however only scores for the impaired (hemiplegic) hand are reported. Scores can range from 0-150, with higher scores indicating better performance of manual dexterity.

Baseline

Group	Value	95% CI
MyHand Orthosis	47	± 2.289

Post Unassisted (week 4)

Group	Value	95% CI
MyHand Orthosis	35	± 1.843

Post Assisted (week 4)

Group	Value	95% CI
MyHand Orthosis	24	± 0.585

Number of Participants Completing Treatment Protocol Secondary · 4 Weeks

The number of participants who completed the full treatment protocol (12 training sessions).

Group	Value	95% CI
MyHand Orthosis	11

Total Number of Adverse Events During Intervention Secondary · 4 Weeks

All adverse events will be tracked during the course of the intervention. The Principal Investigator will review any event and assess it as either adverse or non-significant.

Group	Value	95% CI
MyHand Orthosis	0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. User-Driven Functional Movement Training With a Wearable Hand Robot After Stroke.
   Park S, Fraser M, Weber LM, Meeker C, et al · · 2020 · cited 19× · PMID 32886611 · DOI 10.1109/tnsre.2020.3021691