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Trial record 11 of 16 for:    Foot Drop AND meter

Interactive Exoskeleton Robot for Walking - Ankle Joint

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ClinicalTrials.gov Identifier: NCT02471248
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : September 18, 2017
Sponsor:
Collaborator:
Innovation and Technology Commission, Hong Kong
Information provided by (Responsible Party):
Raymond KY Tong, Chinese University of Hong Kong

Brief Summary:
A novel interactive exoskeleton robotic system with embedded force and motion sensors will be developed to facilitate walking of stroke patients with hemiparesis. The robot will synchronise with the gait pattern of the stroke patient to provide assistance in ankle dorsiflexion during swing phase. It is hypothesised that the robot can facilitate stable and longer walking distance for stroke patients with drop foot problem. It can be applied on unilateral side, which is suitable for stroke patients with hemiparesis. The whole system design is lightweight, compact, comfortable, and user-friendly in hospital or at home settings.

Condition or disease Intervention/treatment Phase
Stroke Device: Ankle Robot with Power Assistance Device: Sham Not Applicable

Detailed Description:
In this clinical trial, participated stroke patients will be divided into two groups: Robotic group and Sham group. Stroke patients in both groups will participate in a 20-session gait training program, which includes overground walking and stair climbing exercises. Robotic group will walk with the powered Ankle Robot, which provide ankle dorsiflexion support during swing phase of walking; Sham group will walk with the Ankle Robot with very low assistance level, which provide only tactile feedback but no ankle support in order to evaluate the placebo effect. A series of clinical assessments will be carried out to assess the functional recovery in stroke patients before and after the gait training program.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interactive Exoskeleton Robot for Walking - Ankle 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: Ankle Robot with Power Assistance
In this experimental group, the Ankle Robot assists the ankle dorsiflexion when the stroke patients voluntarily perform the swing phase gait movement.
Device: Ankle Robot with Power Assistance

Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 * 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote gait recovery and physical fitness.

They will wear the Ankle Robot during the gait training. The motor will synchronise with the paretic-side gait pattern to provide dorsiflexion moment during swing phase, and free the ankle joint when the sole is loaded.


Placebo Comparator: Sham group
In this sham group, the Ankle Robot provides very low assistance to generate tactile feedback to the stroke patients indicating they are performing the swing phase gait movement, but no assistance will be given to support their ankle dorsiflexion.
Device: Sham

Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 * 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote physical fitness.

They will wear the Ankle Robot during the gait training. The robot will synchronise with the paretic-side gait pattern to the Ankle Robot provides very low assistance which can be barely perceived by the stroke patient but does not suffice to support the ankle dorsiflexion.





Primary Outcome Measures :
  1. 6-minute Walk Test [ Time Frame: 3-month follow-up ]
    Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance

  2. Functional Ambulation Category [ Time Frame: 3-month follow-up ]
    Assesses postural stability during various walking tasks


Secondary Outcome Measures :
  1. Timed 10 Meter Walk Test [ Time Frame: 3-month follow-up ]
    Assesses walking speed in meters per second over a short duration

  2. Fugl-Meyer Assessment of Motor Recovery after Stroke (Lower Extremity) [ Time Frame: 3-month follow-up ]
    Evaluates and measures recovery in post-stroke hemiplegic patients

  3. Berg Balance Scale [ Time Frame: 3-month follow-up ]
    A 14-item objective measure designed to assess static balance and fall risk in adult populations

  4. Modified Ashworth Scale [ Time Frame: 3-month follow-up ]
    Measures spasticity in patients with lesions of the Central Nervous System

  5. Kinematic and Kinetic Gait Motion Capture [ Time Frame: 3-month follow-up ]
    Gait pattern will be recorded when the stroke patient is walking under three conditions: (1) without the Ankle Robot, (2) with the Idle Ankle Robot, and (3) with the Powered Ankle Robot.

  6. Subjective Feedback Questionnaire [ Time Frame: 3-month follow-up ]
    Stroke patients will provide subjective feedback about the performance of the Ankle Robot in terms of safety, effectiveness, and their satisfaction after the gait training



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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
Criteria

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 > 21)
  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 follow-up.

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): NCT02471248


Locations
Hong Kong
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Innovation and Technology Commission, Hong Kong
Investigators
Principal Investigator: Raymond KY Tong, PhD Department of Biomedical Engineering, CUHK

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raymond KY Tong, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02471248     History of Changes
Other Study ID Numbers: 2015.037-T (Ankle)
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No