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MyHand: An Active Hand Orthosis for Stroke Patients

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Columbia University

Status

Completed

Conditions

Stroke

Treatments

Device: Shoulder harness
Device: EMG Band

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT03767894
IIS-1526960 (Other Grant/Funding Number)
AAAP8752

Details and patient eligibility

About

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.

Full description

Hand rehabilitation through occupational therapy is critical for many stroke survivors, but it is also greatly limited by insurance coverage, shortage of therapists, and logistic constraints. To address this, stroke patients need a rehabilitation method they can use on their own, without direct clinical supervision, and for activities of daily living. MyHand is a wearable and active hand orthosis consisting of a glove and forearm splint, equipped with actuators and tendons which connect to the fingers.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

MyHand orthosis
Experimental group
Description:
Subjects are trained to control and use the MyHand orthosis either with a shoulder harness or an electromyography (EMG) band. The MyHand orthosis aims to aid in fine motor skills such as picking up and holding items of varying shape, size and weight.
Treatment:
Device: Shoulder harness
Device: EMG Band

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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