Stroke, IschemicNCT04818073
Determinants of the Effectiveness of Robot-assisted Hand Movement Training
A study testing New FINGER in people with Stroke, Ischemic and Cerebrovascular Accident (CVA), run by University of California, Irvine at 1 site in United States.
Trial summary
The investigators would like to investigate the effectiveness of somatosensory training for robot-assisted hand motor rehabilitation after stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Ischemic, Cerebrovascular Accident (CVA)
- What is being tested?
- New FINGER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2022to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 to 85 years
- Suffered from a single ischemic stroke (radiologically confirmed) at least 6-months prior to enrollment
- An ability to score at least 3 blocks on the Box and Block Test
Who cannot join
- A substantial decrease in alertness, language reception or attention
- Pregnant or lactating
- Advanced liver, kidney, cardiac or pulmonary disease
- Plan to alter any current participation in other rehabilitation therapy in the time period of the study
- A terminal medical diagnosis consistent with survival < 1 year
- Coexistent major neurological disease
Show all 10Show fewer
- Coexistent major psychiatric disease
- A history of significant alcohol or drug abuse in the prior 3 years
- Current enrollment in another study related to stroke or stroke recovery
- Any other medical contraindication to participation in this study evaluated by our team physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Irvine
Irvine, California, 92697
About this study
The investigators would like to investigate the effectiveness of somatosensory training for robot-assisted hand motor rehabilitation after stroke.
Read the detailed description
From previous studies, the investigators learned that stroke survivors with impaired finger proprioception did not achieve as large a functional benefit from robotic finger training. For this study, the investigators would like to determine if and the extent of finger proprioception can be improved through targeted robotic proprioceptive training combined with robotic finger movement training. The investigators would also include imagining studies via Electroencephalogram (EEG) and other baseline predictors to provide insight to determine who responds best to proprioceptive training.
- Conditions
- Stroke, Ischemic, Cerebrovascular Accident (CVA)
- Being tested
- New FINGER
- Keywords
- Rehabilitation
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New FINGERDevice
New FINGER exoskeleton is a robotic device that can provide assistance and resistance to thumb and finger movement
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants with undergo new FINGER robotic training with no physical assistance 3 times a week for a period of 3 weeks. Receives: Device: New FINGER |
| Group B | Experimental | Participants will undergo new FINGER robotic training with physical assistance 3 times a week for a period of 3 weeks. Receives: Device: New FINGER |
| Group C | Experimental | Participants will undergo new FINGER robotic training with physical assistance and proprioceptive exercises 3 times a week for a period of 3 weeks. Receives: Device: New FINGER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Blocks Test
We compare the change of Box and Block Test scores from baseline evaluation to 1-month post intervention. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.
Measured: From baseline to 1-month post intervention
Secondary outcomes (3)
Fugl-Meyer Motor Assessment of the Upper Extremity
We will measure the change of the Fugl-Meyer Motor Assessment scores from the baseline evaluation to 1-month post intervention. Fugl-Meyer is a 66-point scale measuring the movement pattern of upper extremities. The higher scores indicate a better outcome.
Measured: From baseline to 1-month post intervention
Motor Activity Log
We will measure the change of the Motor Activity Log (MAL) mean scores from the baseline evaluation to 1-month post intervention. The Motor Activity Log is a 30 questionnaire that collect subjective measure of an individual's real life functional upper limb performance. The higher scores indicate a better outcome.
Measured: From baseline to 1-month post intervention
Changes in finger proprioception measured using the Crisscross Assessment.
We will measure the change in finger proprioception scores from the baseline evaluation to 1-month post intervention. Finger proprioception is measured by using the FINGER Crisscross Assessment which we slowly move the index and middle fingers with the FINGER robot past each other without any visual input. We then ask study participants to press a key when they feel the fingers are overlapped. Finger proprioception is measured by the error which will be quantified as the mean magnitude of finger separation error at the metacarpal joint when the key is pressed. The lower scores indicate a better outcome.
Measured: From baseline to 1-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start6 May 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Idaho, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, David Reinkensmeyer, University of California, Irvine
- Investigators
- David Reinkensmeyer, Ph.D, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818073
- Sponsor's protocol ID
- 476
- Other IDs
- 2R01HD062744-06
- Status last verified
- Oct 2024
- First submitted
- 23 Mar 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rowe JB, Chan V, Ingemanson ML, Cramer SC, Wolbrecht ET, Reinkensmeyer DJ. Robotic Assistance for Training Finger Movement Using a Hebbian Model: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2017 Aug;31(8):769-780. doi: 10.1177/1545968317721975.
PubMed 28803535Ingemanson ML, Rowe JB, Chan V, Wolbrecht ET, Cramer SC, Reinkensmeyer DJ. Use of a robotic device to measure age-related decline in finger proprioception. Exp Brain Res. 2016 Jan;234(1):83-93. doi: 10.1007/s00221-015-4440-4. Epub 2015 Sep 16.
PubMed 26378004
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of the Effectiveness of Robot-assisted Hand Movement Training
- ClinicalTrials.gov ID
- NCT04818073
- Acronym / sponsor ID
- 476
- Conditions
- Stroke, Ischemic, Cerebrovascular Accident (CVA)
- Keywords
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of Idaho, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 May 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 26 Mar 2021 (actual)
- 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 investigators would like to investigate the effectiveness of somatosensory training for robot-assisted hand motor rehabilitation after stroke.
Detailed description
From previous studies, the investigators learned that stroke survivors with impaired finger proprioception did not achieve as large a functional benefit from robotic finger training. For this study, the investigators would like to determine if and the extent of finger proprioception can be improved through targeted robotic proprioceptive training combined with robotic finger movement training. The investigators would also include imagining studies via Electroencephalogram (EEG) and other baseline predictors to provide insight to determine who responds best to proprioceptive training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: New FINGERParticipants with undergo new FINGER robotic training with no physical assistance 3 times a week for a period of 3 weeks. |
| Group B | Experimental | Device: New FINGERParticipants will undergo new FINGER robotic training with physical assistance 3 times a week for a period of 3 weeks. |
| Group C | Experimental | Device: New FINGERParticipants will undergo new FINGER robotic training with physical assistance and proprioceptive exercises 3 times a week for a period of 3 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 85 years
- Suffered from a single ischemic stroke (radiologically confirmed) at least 6-months prior to enrollment
- An ability to score at least 3 blocks on the Box and Block Test
Key exclusion criteria (10 listed)
- A substantial decrease in alertness, language reception or attention
- Pregnant or lactating
- Advanced liver, kidney, cardiac or pulmonary disease
- Plan to alter any current participation in other rehabilitation therapy in the time period of the study
- A terminal medical diagnosis consistent with survival < 1 year
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 |
|---|---|---|
| New FINGERNew FINGER exoskeleton is a robotic device that can provide assistance and resistance to thumb and finger movement | Device | Group A, Group B, Group C |
Primary outcome
Box and Blocks Test
Time frame: From baseline to 1-month post intervention
We compare the change of Box and Block Test scores from baseline evaluation to 1-month post intervention. Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicate a better outcome.
3 secondary outcomes
Fugl-Meyer Motor Assessment of the Upper Extremity
Time frame: From baseline to 1-month post intervention
Motor Activity Log
Time frame: From baseline to 1-month post intervention
Changes in finger proprioception measured using the Crisscross Assessment.
Time frame: From baseline to 1-month post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 28803535Rowe JB, Chan V, Ingemanson ML, Cramer SC, Wolbrecht ET, Reinkensmeyer DJ. Robotic Assistance for Training Finger Movement Using a Hebbian Model: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2017 Aug;31(8):769-780. doi: 10.1177/1545968317721975.
- Background: PubMed 26378004Ingemanson ML, Rowe JB, Chan V, Wolbrecht ET, Cramer SC, Reinkensmeyer DJ. Use of a robotic device to measure age-related decline in finger proprioception. Exp Brain Res. 2016 Jan;234(1):83-93. doi: 10.1007/s00221-015-4440-4. Epub 2015 Sep 16.
- 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, Ph.D 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 New FINGER in people with Stroke, Ischemic and Cerebrovascular Accident (CVA), 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 3 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Box and Blocks Test (time frame: From baseline to 1-month post intervention). 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 NCT04818073, which also lists 2 linked publications.
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 15 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.