Interactive Exoskeleton Robot for Walking - Knee Joint

Stroke Clinical Trial

Official title:

Interactive Exoskeleton Robot for Walking - Knee Joint

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497703
• Other study ID #: 2015.037T (Knee)
• Status: Completed
• Phase: N/A
• First received: July 12, 2015
• Last updated: September 15, 2017
• Start date: May 27, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: September 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2016
• Est. primary completion date: October 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Knee robot

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Kinematic and Kinetic Gait Motion Capture	Motion analysis to evaluation the ankle, knee and hip angles; and ground reaction force	3-month followup
Secondary	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
Secondary	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
Secondary	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
Secondary	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