Interactive Exoskeleton Robot for Walking - Knee Joint

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02497703
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : September 18, 2017
The Hong Kong Polytechnic University
Information provided by (Responsible Party):
Raymond KY Tong, Chinese University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Device: Knee robot Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interactive Exoskeleton Robot for Walking - Knee Joint
Actual Study Start Date : May 27, 2015
Actual Primary Completion Date : October 14, 2016
Actual Study Completion Date : December 31, 2016

Arm Intervention/treatment
Experimental: Knee robot
This robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton
Device: Knee robot

Primary Outcome Measures :
  1. Functional Ambulation Category [ Time Frame: 3-month followup ]

    Patients can be rated on the following categories:

    0: Patient cannot walk, or needs help from 2 or more persons

    1. Patients needs firm continuous support from 1 person who helps carrying weight and with balance
    2. Patient needs continuous or intermittent support of one person to help with balance and coordination.
    3. Patient requires verbal supervision or stand-by help from one person without physical contact
    4. Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces
    5. Patient can walk independently anywhere

  2. 6-minute Walk Test [ Time Frame: 3-month followup ]
    Walk as far a distance as possible over 6 minutes with their preferred speed; assistive devices can be used but kept consistent from test to test Individual should be able to ambulate without physical assistance.

Secondary Outcome Measures :
  1. Kinematic and Kinetic Gait Motion Capture [ Time Frame: 3-month followup ]
    Motion analysis to evaluation the ankle, knee and hip angles; and ground reaction force

  2. Fugl-Meyer Assessment Lower Extremity [ Time Frame: 3-month followup ]
    Evaluates and measures motor function recovery in post-stroke hemiplegic patients Used in both clinical and research settings, maximum score = 34

  3. Timed 10-meter Walk Test [ Time Frame: 3-month followup ]
    The individual is instructed to walk a set distance (10 meters). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed (this distance is not included when determining speed). The distance covered is divided by the time it took the individual to walk that distance.

  4. Modified Ashworth Scale [ Time Frame: 3-month followup ]
    Tests resistance to passive movement about a joint with varying degrees of velocity; scores range from 0-4, with 6 choices

  5. Berg Balance Scale [ Time Frame: 3-month followup ]
    Static and dynamic activities of varying difficulty are performed Item-level scores range from 0-4, determined by ability to perform the assessed activity Item scores are summed Maximum score = 56

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02497703

Hong Kong
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Interdisciplinary Division of Biomedical Engineering. The Hong Kong Polytechnic Univesity
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
The Hong Kong Polytechnic University

Responsible Party: Raymond KY Tong, Professor, Chinese University of Hong Kong Identifier: NCT02497703     History of Changes
Other Study ID Numbers: 2015.037T (Knee)
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017