NCT02497703

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

1.4 years

First QC Date

July 12, 2015

Last Update Submit

September 15, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • Functional Ambulation Category

    Patients can be rated on the following categories: 0: Patient cannot walk, or needs help from 2 or more persons 1. Patients needs firm continuous support from 1 person who helps carrying weight and with balance 2. Patient needs continuous or intermittent support of one person to help with balance and coordination. 3. Patient requires verbal supervision or stand-by help from one person without physical contact 4. Patient can walk independently on level ground, but requires help on stairs, slopes or uneven surfaces 5. 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 Outcomes (5)

  • Kinematic and Kinetic Gait Motion Capture

    3-month followup

  • Fugl-Meyer Assessment Lower Extremity

    3-month followup

  • Timed 10-meter Walk Test

    3-month followup

  • Modified Ashworth Scale

    3-month followup

  • Berg Balance Scale

    3-month followup

Study Arms (1)

Knee robot

EXPERIMENTAL

This robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton

Device: Knee robot

Interventions

Knee robotDEVICE
Knee robot

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Interdisciplinary Division of Biomedical Engineering. The Hong Kong Polytechnic Univesity

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 12, 2015

First Posted

July 14, 2015

Study Start

May 27, 2015

Primary Completion

October 14, 2016

Study Completion

December 31, 2016

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

HK(2)