StrokeNCT02077439
Interactive Intention-Driven Upper-Limb Training Robotic System
A study testing Hand Robotic Training, Hand and Arm Robotic Training and Conventional therapy in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- Hand Robotic Training, Hand and Arm Robotic Training and Conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2014to 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
Who cannot join
- Excessive spasticity of the affected arm
- Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial: Interactive Intention-Driven Upper-Limb Training Robotic System
The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.
Read the detailed description
This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system.
Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy.
There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.
- Conditions
- Stroke
- Being tested
- Hand Robotic Training, Hand and Arm Robotic Training, Conventional therapy
- Keywords
- Stroke, Hand, Upper Extremity, Robotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Robotic TrainingDevice
Training for 20 sessions for one hour, 3-5 times per week.
Hand and Arm Robotic TrainingDevice
Training for 20 sessions for one hour, 3-5 times per week.
Conventional therapyOther
Training for 20 sessions for one hour, 3-5 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Hand Robotic Training | Experimental | Hand Robotic Training Receives: Device: Hand Robotic Training |
| Hand and Arm Robotic Training | Experimental | Hand and Arm Robotic Training Receives: Device: Hand and Arm Robotic Training |
| Conventional therapy | Active comparator | Conventional therapy Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment
Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months.
Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Measured: Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months
Action Research Arm Test
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months.
Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Measured: Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months
Secondary outcomes (2)
Wolf Motor Function Test
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months.
Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Measured: Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months
modified Ashworth Scale
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months.
Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Measured: Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJan 2014
- Primary completion31 Dec 2015
- 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 The Hong Kong Polytechnic UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond KY Tong, The Hong Kong Polytechnic University
- Investigators
- Raymond KY Tong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077439
- Sponsor's protocol ID
- ITT/004/12GP
- Status last verified
- Feb 2017
- First submitted
- 27 Feb 2014
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial: Interactive Intention-Driven Upper-Limb Training Robotic System
- ClinicalTrials.gov ID
- NCT02077439
- Acronym / sponsor ID
- ITT/004/12GP
- Conditions
- Stroke
- Keywords
- Stroke, Hand, Upper Extremity, Robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 4 Mar 2014 (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.
The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.
Detailed description
This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system.
Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy.
There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hand Robotic Training | Experimental | Device: Hand Robotic TrainingHand Robotic Training |
| Hand and Arm Robotic Training | Experimental | Device: Hand and Arm Robotic TrainingHand and Arm Robotic Training |
| Conventional therapy | Active comparator | Other: Conventional therapyConventional therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
Key exclusion criteria (2 listed)
- Excessive spasticity of the affected arm
- Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
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 |
|---|---|---|
| Hand Robotic TrainingTraining for 20 sessions for one hour, 3-5 times per week. | Device | Hand Robotic Training |
| Hand and Arm Robotic TrainingTraining for 20 sessions for one hour, 3-5 times per week. | Device | Hand and Arm Robotic Training |
| Conventional therapyTraining for 20 sessions for one hour, 3-5 times per week. | Other | Conventional therapy |
Primary outcome
Fugl-Meyer Assessment
Time frame: Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months
Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months. Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
Action Research Arm Test
Time frame: Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.
2 secondary outcomes
Wolf Motor Function Test
Time frame: Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months
modified Ashworth Scale
Time frame: Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months
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 24 Feb 2017.
- The Hong Kong Polytechnic UniversityLink provided by the sponsor.
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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.
Raymond KY Tong, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Robotic Training, Hand and Arm Robotic Training and Conventional therapy in people with Stroke, run by The Hong Kong Polytechnic University at 1 site 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 1 inclusion and 2 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Fugl-Meyer Assessment (time frame: Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months). 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 24 Feb 2017.