StrokeNCT02497703
Interactive Exoskeleton Robot for Walking - Knee Joint
A study testing Knee robot in people with Stroke, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Knee robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesHong Kong
- Study dates
- 27 May 2015to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Department of Biomedical Engineering, The Chinese University of Hong Kong
Hong Kong
Interdisciplinary Division of Biomedical Engineering. The Hong Kong Polytechnic Univesity
Hong Kong
About this study
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.
- Conditions
- Stroke
- Being tested
- Knee robot
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee robotDevice
| Study group | Role | What they receive |
|---|---|---|
| Knee robot | Experimental | This robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton Receives: Device: Knee robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3-month followup
Secondary outcomes (5)
Kinematic and Kinetic Gait Motion Capture
Motion analysis to evaluation the ankle, knee and hip angles; and ground reaction force
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 3-month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start27 May 2015
- Primary completion14 Oct 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Raymond KY Tong, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497703
- Sponsor's protocol ID
- 2015.037T (Knee)
- Status last verified
- Sep 2017
- First submitted
- 12 Jul 2015
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Exoskeleton Robot for Walking - Knee Joint
- ClinicalTrials.gov ID
- NCT02497703
- Acronym / sponsor ID
- 2015.037T (Knee)
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 27 May 2015 (actual)
- Primary completion
- 14 Oct 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee robot | Experimental | Device: Knee robotThis robotic system has been developed to facilitate functional motor recovery by practices walking with a one joint motor powered exoskeleton |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee robot | Device | Knee robot |
Primary outcome
Functional Ambulation Category
Time frame: 3-month followup
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
6-minute Walk Test
Time frame: 3-month followup
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.
5 secondary outcomes
Kinematic and Kinetic Gait Motion Capture
Time frame: 3-month followup
Fugl-Meyer Assessment Lower Extremity
Time frame: 3-month followup
Timed 10-meter Walk Test
Time frame: 3-month followup
Modified Ashworth Scale
Time frame: 3-month followup
Berg Balance Scale
Time frame: 3-month followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
Related trials for Stroke
Recruiting
The AHA Oneida Study
Oneida Nation Members
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Active, not recruiting
Brain Connectivity Analysis
Neural Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee robot in people with Stroke, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Ambulation Category (time frame: 3-month followup). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.