Soft Robotic Hand System for Stroke Rehabilitation

The Chinese University of Hong Kong

Status: Unknown

Conditions: Stroke

Treatments: Device: soft robot hand system

Study type: Interventional

Funder types: Other

Identifiers

NCT03286309

2017.396-T

Details and patient eligibility

About

The soft robotic system could provide objective and quantifiable measures of subject performance. By combining voluntary motor intention and the robotic hand technology, the system will facilitate the recovery process of stroke patients.

Enrollment: 40 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. at chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic);
2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study;
3. able to sit up for 45 minutes (with or without assistance).

Exclusion criteria

1. Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication;
2. any additional medical or psychological condition affecting their ability to comply with the study protocol;
3. history of other neurological disease, psychiatric disorder, including alcoholism and substance abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

EMG-driven soft robot hand

Experimental group

Description:

subjects will receive EMG-driven soft robot hand system.

Treatment:

Device: soft robot hand system

sham group

Placebo Comparator group

Description:

subjects will receive passive pre-programmed soft robot hand system.

Treatment:

Device: soft robot hand system