Soft Robotic Hand System for Stroke Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-12

Study Completion Date

2022-07-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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EMG-driven soft robot hand

subjects will receive EMG-driven soft robot hand system.

Group Type EXPERIMENTAL

soft robot hand system

Intervention Type DEVICE

subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.

sham group

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

Group Type PLACEBO_COMPARATOR

soft robot hand system

Intervention Type DEVICE

subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.

Interventions

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soft robot hand system

subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes