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Completed

NCT Number: NCT02497703

Interactive Exoskeleton Robot for Walking - Knee Joint

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biomedical Engineering, The Chinese University of Hong Kong, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Any severe contractures in hip, knee, or ankle joint that would preclude passive range of motion in the lower extremity.
  • Participation in any therapeutic treatment ("outside therapy") performed with the lower extremity during the planned study, including the baseline and the followup.

Treatment and study plan

Knee robot

Device

Primary outcomes

  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

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

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • The Hong Kong Polytechnic University

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2015
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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