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Interactive Exoskeleton Robot for Walking - Knee Joint

NCT ID: NCT02497703

Last Updated: 2017-09-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-27

Study Completion Date

2016-12-31

Brief Summary

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An exoskeleton robotic knee system for stroke rehabilitation is proposed in this study. This robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton to reduce the muscle weakness in the shank and reduce the hyperextension in the knee joint. The robotic knee system is able to sense the gait pattern from the stroke patients and assist the walking and control the knee angle. The clinical trial will use repeated measurements to evaluate the effectiveness of the robotic knee system in gait rehabilitation post stroke.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Knee robot

This robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton

Group Type EXPERIMENTAL

Knee robot

Intervention Type DEVICE

Interventions

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Knee robot

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Ischemic or hemorrphagic stroke with drop foot problem.
2. Sufficient cognition to follow simple instructions and to understand the content and purpose of the study. (Mini-Mental State Examination \> 20)
3. Capable of standing and walking independently for an extended period of time. (Functional Ambulation Category \> 3, Berg Balance Scale \> 40)

Exclusion Criteria

1. Any medical or psychological dysfunctions that would affect their ability to comply with test study protocol, such as lower back pain, neuralgia, rotational vertigo, muscloskeletal disorders, injuries, and pregnancy.
2. Any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity.
3. Participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the followup.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Raymond KY Tong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Interdisciplinary Division of Biomedical Engineering. The Hong Kong Polytechnic Univesity

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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2015.037T (Knee)

Identifier Type: -

Identifier Source: org_study_id