Cerebrovascular AccidentNCT02048826
FINGER Robot Therapy Study
A study testing FINGER I and FINGER II in people with Cerebrovascular Accident, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of training hand movement using FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users to play computer games using those movements. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- FINGER I and FINGER II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years of age
- Have history of stroke affecting the arm, at least 6 months prior to enrollment
- have arm and/or hand weakness as measured on a standard clinical scale
- do not have active major psychological problems, or problems affecting the stroke-affected arm or hand besides the stroke
- do not have active major brain disease other than the stroke
- have absence of pain in the stroke-affected arm and hand
Who cannot join
- severe stiffness of the arm or hand as measured on a standard clinical scale
- severe problems speaking or understanding speech as measured on a standard clinical scale
- severe reduced level of consciousness
- severe loss ability to sense movement of your limbs as measured on a standard clinical scale
- currently pregnant
- difficulty in understanding or complying with the instructions given by the researcher
Show all 14Show fewer
- inability to perform the experimental task that will be studied
- increased pain with movement of the stroke-affected arm or hand
- Exclusion criteria that will prevent subjects from participating in the MRI:
- Subjects having any implanted metal such as metallic splinters, metallic surgical clips, prosthetic heart valves, pacemakers, neuro-stimulation devices, orthodontic work that contains ferromagnetic materials,
- Subjects whose occupation or activities may cause accidental lodging of ferromagnetic materials, or that may have imbedded metal fragments from military activities, unless cleared by a screening head CT scan
- Subjects with tattoo(s) presenting metallic or ferromagnetic color ingredients or with facial make-up
- Subjects who have claustrophobia
- Subjects who are currently pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Irvine, California, 92697
About this study
Official title: Study of Influence of Timing on Motor Learning
The purpose of this study is to determine the effectiveness of training hand movement using FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users to play computer games using those movements.
Read the detailed description
Robotic devices can be used to retrain movement after stroke. However, it is unclear how best to assist in movement. Providing physical assistance may improve the flow of proprioceptive information to the nervous system, which may help a person relearn to move a limb. On the other hand, assisting movement with a robot may cause a person to "slack", not trying as hard during therapy. This study will test the effect of different levels of assistance on recovery of finger function during robot-assisted therapy after stroke.
- Conditions
- Cerebrovascular Accident
- Being tested
- FINGER I, FINGER II
- Keywords
- stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FINGER IDevice
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
FINGER IIDevice
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
| Study group | Role | What they receive |
|---|---|---|
| FINGER I | Experimental | Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program Receives: Device: FINGER I; Device: FINGER II |
| FINGER II | Experimental | Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program Receives: Device: FINGER I; Device: FINGER II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed
The primary endpoint was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 seconds, from baseline to 1-month post-therapy. The higher the scores, the better arm and hand function indicated.
Measured: From baseline to 1-month post therapy
Secondary outcomes (2)
Motor and Strength Measure Using Action Research Arm Test Measured as a Score
We compared the change in Action Research Arm Test (ARAT) scores from the baseline evaluation to 1-month post-therapy evaluation. The ARAT is a 57-point scale, 0 being the minimum scoreand 57 being the maximum score, that measures upper extremity function, coordination, and dexterity. The higher scores indicate a better outcome.
Measured: From baseline to 1-month post therapy
Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score
The primary outcome measure was the change in Upper Extremity Fugl-Meyer score on a scale of 0 to 66 at one-month post-therapy. The higher the scores, the better arm and hand function indicated.
Measured: From baseline to 1-month post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Reinkensmeyer, University of California, Irvine
- Investigators
- David Reinkensmeyer, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048826
- Sponsor's protocol ID
- HS#2008-6432
- Status last verified
- Mar 2021
- First submitted
- 27 Jan 2014
- Last updated
- 25 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ingemanson ML, Rowe JR, Chan V, Wolbrecht ET, Reinkensmeyer DJ, Cramer SC. Somatosensory system integrity explains differences in treatment response after stroke. Neurology. 2019 Mar 5;92(10):e1098-e1108. doi: 10.1212/WNL.0000000000007041. Epub 2019 Feb 6.
PubMed 30728310
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Influence of Timing on Motor Learning
- ClinicalTrials.gov ID
- NCT02048826
- Acronym / sponsor ID
- HS#2008-6432
- Conditions
- Cerebrovascular Accident
- Keywords
- stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Posted 25 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of training hand movement using FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users to play computer games using those movements.
Detailed description
Robotic devices can be used to retrain movement after stroke. However, it is unclear how best to assist in movement. Providing physical assistance may improve the flow of proprioceptive information to the nervous system, which may help a person relearn to move a limb. On the other hand, assisting movement with a robot may cause a person to "slack", not trying as hard during therapy. This study will test the effect of different levels of assistance on recovery of finger function during robot-assisted therapy after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FINGER I | Experimental | Device: FINGER I, Device: FINGER IISubjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program |
| FINGER II | Experimental | Device: FINGER I, Device: FINGER IISubjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 80 years of age
- Have history of stroke affecting the arm, at least 6 months prior to enrollment
- have arm and/or hand weakness as measured on a standard clinical scale
- do not have active major psychological problems, or problems affecting the stroke-affected arm or hand besides the stroke
- do not have active major brain disease other than the stroke
Key exclusion criteria (14 listed)
- severe stiffness of the arm or hand as measured on a standard clinical scale
- severe problems speaking or understanding speech as measured on a standard clinical scale
- severe reduced level of consciousness
- severe loss ability to sense movement of your limbs as measured on a standard clinical scale
- currently pregnant
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 |
|---|---|---|
| FINGER IFINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I | Device | FINGER I, FINGER II |
| FINGER IIFINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II | Device | FINGER I, FINGER II |
Primary outcome
Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed
Time frame: From baseline to 1-month post therapy
The primary endpoint was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 seconds, from baseline to 1-month post-therapy. The higher the scores, the better arm and hand function indicated.
2 secondary outcomes
Motor and Strength Measure Using Action Research Arm Test Measured as a Score
Time frame: From baseline to 1-month post therapy
Motor, Strength and Sensory Using Fugl-Meyer Test Measured as a Score
Time frame: From baseline to 1-month post therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30728310Ingemanson ML, Rowe JR, Chan V, Wolbrecht ET, Reinkensmeyer DJ, Cramer SC. Somatosensory system integrity explains differences in treatment response after stroke. Neurology. 2019 Mar 5;92(10):e1098-e1108. doi: 10.1212/WNL.0000000000007041. Epub 2019 Feb 6.
- Individual participant dataSharing planned: No
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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.
David Reinkensmeyer, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FINGER I and FINGER II in people with Cerebrovascular Accident, run by University of California, Irvine at 1 site in United States.
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 6 inclusion and 14 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 25 Mar 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Motor and Strength Outcome Measure Using Box and Block Test Measured in Units of Blocks Placed (time frame: From baseline to 1-month post therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02048826, which also lists 1 linked publication.
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 25 Mar 2021.