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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Knee robot

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Ambulation Category	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	3-month followup
6-minute Walk Test	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.	3-month followup

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematic and Kinetic Gait Motion Capture	Motion analysis to evaluation the ankle, knee and hip angles; and ground reaction force	3-month followup
Fugl-Meyer Assessment Lower Extremity	Evaluates and measures motor function recovery in post-stroke hemiplegic patients Used in both clinical and research settings, maximum score = 34	3-month followup
Timed 10-meter Walk Test	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.	3-month followup
Modified Ashworth Scale	Tests resistance to passive movement about a joint with varying degrees of velocity; scores range from 0-4, with 6 choices	3-month followup
Berg Balance Scale	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	3-month followup

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2015
• Primary Completion (Actual): October 14, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: July 12, 2015
• First Submitted That Met QC Criteria: July 12, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2015.037T (Knee)