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Interactive Exoskeleton Robot for Walking

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ClinicalTrials.gov Identifier: NCT03184259
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Raymond KY Tong, Chinese University of Hong Kong

Brief Summary:
A new lower-limb training system is introduced to enhance the clinical service for post-stroke lower limb rehabilitation and to assist the establishment of public clinical trial in different settings and share experiences on the robot-assisted functional training.

Condition or disease Intervention/treatment Phase
Stroke Device: Robotic ankle system Device: Robotic knee system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Wearable Interactive Lower-limb Exoskeleton Robotic Device for Gait Training of Post-stroke Patients on Different Walking Conditions
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : June 12, 2019
Estimated Study Completion Date : June 12, 2019

Arm Intervention/treatment
Experimental: Robotic ankle system
Subjects will wear the Ankle Robot during 20-session gait training, power assistance will be provided from the motor to the ankle joint.
Device: Robotic ankle system
Patients will wear the robotic ankle system and undergo 20-minute over-ground walking and 10-minute stair walking.
Other Name: Ankle Robot

Experimental: Robotic knee system
Subjects will wear the Knee Robot during 20-session gait training, power assistance will be provided from the motor to the knee joint.
Device: Robotic knee system
Patients will wear the robotic knee system and undergo 20-minute over-ground walking and 10-minute stair walking.
Other Name: Knee Robot

Placebo Comparator: Ankle Sham group
Subjects will wear the Ankle Robot during 20-session gait training, but no power assistance will be provided from the motor to the ankle joint.
Device: Robotic ankle system
Patients will wear the robotic ankle system and undergo 20-minute over-ground walking and 10-minute stair walking.
Other Name: Ankle Robot

Placebo Comparator: Knee Sham group
Subjects will wear the Knee Robot during 20-session gait training, but no power assistance will be provided from the motor to the knee joint.
Device: Robotic knee system
Patients will wear the robotic knee system and undergo 20-minute over-ground walking and 10-minute stair walking.
Other Name: Knee Robot

No Intervention: Health Control
Healthy subjects will wear the Ankle Robot and/or Knee Robot during walking tasks (with or without power assistance), to collect control data for investigating if there are any effects of the robotic assistance on normal gait pattern.



Primary Outcome Measures :
  1. Functional Ambulatory Category (FAC) [ Time Frame: Baseline, Post-Training, 3-month follow up ]
    Functional Ambulatory Category (FAC) is a reliable measurement of independent walking ability on level-ground walking and stair ambulation, which is a good prediction of independent community walking post-stroke (Mehrholz, et al., 2007). FAC consists of 6-level scale: patients with FAC=4 requires supervision in level ground walking, FAC=5 requires supervision only when walking on non-level surface such as stairs.


Secondary Outcome Measures :
  1. Fugl-Meyer Assessment for Lower-Extremity (FMA-LE) [ Time Frame: Baseline, Post-Training, 3-month follow up ]
    Fugl-Meyer Assessment for Lower-Extremity (FMA-LE), consists of 34-level cumulative scoring system to examine lower-limb functions of hemiplegic stroke patients quantitatively through a set of lower-limb movement tasks in reflex, flexor/extensor synergy, volitional movement, coordination and speed (Fugl-Meyer, et al., 1975). All assessment items are either scoring "full", "partial", or "none" functionality in the affected side, which minimizes ceiling and floor effects. FMA-LE demonstrated high internal consistency and a reliable assessment tool for a group of 140 hemiplegic community dwelling patients (Park & Choi, 2014).

  2. Modified Ashworth Scale (MAS) [ Time Frame: Baseline, Post-Training, 3-month follow up ]
    Modified Ashworth Scale (MAS), consists of 4-level scale to examine joint spasticity based on muscle tone and resistance detected during passive stretching with good inter-rater reliability (ICC =0.85) (Bohannon & Smith, 1987).

  3. Berg Balance Scale (BBS) [ Time Frame: Baseline, Post-Training, 3-month follow up ]
    Berg Balance Scale (BBS), consists of 56-level measures to examine balance ability and to predict falling risk with high reliability (ICC=0.98) (Steffen, Hacker & Mollinger, 2002). Stroke patients were assessed based on their performance on 14 simple mobility tasks, including transfer, standing, and reaching.

  4. Timed 10-Meter Walk Test (10mWT) [ Time Frame: Baseline, Post-Training, 3-month follow up ]
    Timed 10-Meter Walk Test (10mWT), measures comfortable and fast walking speeds in short distance. The ability to increase walking speed above a comfortable pace suggests the capability to adapt to varying environments, such as crossing street, with high reliability (ICC=0.90-0.96) (Flansbjer, et al., 2005). Average walking speed of healthy elderly subjects ranges in 0.6m/s-1.4m/s, and can increase to 21%-56% above the comfortable pace for faster walking speed.

  5. 6-minute Walk Test (SMWT) [ Time Frame: Baseline, Post-Training, 3-month follow up ]
    Six-Minute Walk Test (SMWT), measures the maximum walking distance covered in fixed duration as a sub-maximal test of endurance and aerobic capacity. The measurement of 6MWT is highly correlated to FAC (Mehrholz, et al., 2007) with good reliability (ICC=0.94-0.96) (Steffen, Hacker & Mollinger, 2002).


Other Outcome Measures:
  1. Gait Analysis with EMG Collection [ Time Frame: Baseline, Post-Training ]
    The spatial-temporal, kinetic, and kinematic gait parameters of the stroke patients were collected at the hip, knee, and ankle joints. In addition, the foot tilt angle was computed using the absolute angle between the affected foot and the ground, which is negative when the foot is pointing downwards. This angle measurement can help identifying abnormality in foot orientation during walking, such as foot slapping at initial contact or dropped foot pointing downwards after mid-swing (Zhang, Davies & Xie, 2013). Electromyography (EMG) of the lower limb muscles were also collected to investigate the muscle recruitment during walking with the robotic assistance.

  2. Subjective Feedback from Participants [ Time Frame: Post-Training ]
    Subjective feedbacks were collected from participated stroke patients using questionnaire, with three 10-point Likert scale rating asking them about safety, effectiveness, and overall satisfaction of the gait training with the Exoskeleton Ankle Robot, with reference to the other conventional physiotherapy they had received before participating in this trial. Likert scale has been shown to measure satisfaction with good reliability (Wittink & Bayer, 1994).

  3. Mini-Mental State Examination (MMSE) [ Time Frame: Baseline ]
    Mini-Mental State Examination (MMSE), assesses the cognitive capability of the subject to make sure they understand the purpose of participation in the clinical trial.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. First episode of stroke,
  2. Hemiparesis resulting from a unilateral ischemic or hemorrhagic stroke,
  3. Functional Ambulation Category (FAC) > 2 out of 6, i.e. have ability to walk on the ground independently or under supervision, with or without assistive device,
  4. Have sufficient cognition to follow instructions and to understand the content and purpose of the study.

Exclusion Criteria:

  1. Uncontrolled cardiovascular or respiratory disorders,
  2. Moderate to serve contractures in the lower extremities,
  3. Orthopedic problems or muscle diseases that impair mobility,
  4. Difficulty to comply with the study protocol and the gait training schedule, i.e. at least 2 sessions per week.

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 ClinicalTrials.gov identifier (NCT number): NCT03184259


Contacts
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Contact: Raymond Kai-yu Tong, PhD +852 3943 8454 kytong@cuhk.edu.hk

Locations
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Hong Kong
Department of Biomedical Engineering, The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Raymond Tong, PhD    +852 3943 8454      
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Raymond Kai-yu Tong, PhD Department of Biomedical Engineering, CUHK
Additional Information:
Publications of Results:
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Responsible Party: Raymond KY Tong, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03184259    
Other Study ID Numbers: ITT/012/16GP
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raymond KY Tong, Chinese University of Hong Kong:
Stroke
Exoskeleton Robot
Rehabilitation
Ankle Foot Orthosis
Knee Brace
Foot Drop
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases