StrokePhase 1/2NCT04229329
Effects of Intensive Training on Reocvery of Fingers Dexterity Following Stroke
A Phase 1/2 study testing Intensive Finger Individuation Therapy and Intensive non-directed finger movement therapy in people with Stroke, run by Loewenstein Hospital at 1 site in Israel.
Trial summary
The investigators aim to test whether intensive training of finger individuation during the sensitive window of the subacute phases can lead to a clinically-meaningful recovery of dexterous movement in stroke patients. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Intensive Finger Individuation Therapy and Intensive non-directed finger movement therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2021to 1 Mar 2026
- Phase
- Phase 1/2
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First symptomatic ischemic or hemorrhagic stroke
- Clinically evident upper-limb motor deficit
- Understand the study aim, is able to cooperate with the task for the specified time
- Clinically stable
Who cannot join
- Other neurological or psychiatric illness which affects upper-limb motor function
- An orthopedic or rheumatologic disease that affects the ability to undergo a robotic hand therapy.
- Sensory problems that prevent the patient from reporting pain during the robotic hand therapy
- Skin breakdown or wounds located in places where the hand contacts the robot.
- Patients with C/I to TMS (history of seizures, the existence of cardiac pacer, VP shunt, spinal stimulator or any other hardware that may malfunction at the presence of strong magnetic fields) will no undergo TMS but may participate in the study
- Participation in another interventional study for upper limb rehabilitation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Loewenstein Rehabilitation Center
Raanana, 43100
shay ofir, 972-522204842, shinofir@gmail.com
About this study
Official title: The Effect of Intensive Training on Recovery of Fingers Dexterity Following Stroke: Behavioral, Physiological and Anatomical Predictors
The investigators aim to test whether intensive training of finger individuation during the sensitive window of the subacute phases can lead to a clinically-meaningful recovery of dexterous movement in stroke patients.
- Conditions
- Stroke
- Being tested
- Intensive Finger Individuation Therapy, Intensive non-directed finger movement therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Finger Individuation TherapyCombination product
Interactive robot-mediated treatment aimed at increased individuation done repeatedly for at least1 hour per day for 2 weeks (5 training days a week).
Intensive non-directed finger movement therapyCombination product
Interactive robot-mediated treatment not aimed specifically at increased individuation done repeatedly for at least 1 hour per day for 2 weeks (5 training days per week)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded visually and auditory when a higher degree of finger individuation will be measured. Specifically, when the applied force of the instructed fingers hit the predefined force target and at the same, the force in the non-instructed fingers stay as low as possible Receives: Combination Product: Intensive Finger Individuation Therapy |
| Control | Sham comparator | The patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded in a way that is unrelated to the degree of individuation. In other words, a successful trial considered when the applied force of the instructed fingers hits the predefined force target regardless of the force exerted in the non-instructed fingers. Receives: Combination Product: Intensive non-directed finger movement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment Score for Upper Extremity at the immediate post-intervention time
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Measured: Change from Baseline Score at 1-3 days post-intervention
Change in Fugl-Meyer Assessment Score for Upper Extermity at 1-month post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Measured: Change from Baseline Score at 1 month post-intervention
Change in Fugl-Meyer Assessment Score for Upper Extermity at 3-month post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Measured: Change from Baseline Score at 3 month post-intervention
Change in Individuation Index at the immediate post-intervention time
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Measured: Change from Baseline Score at 1-3 days post-intervention
Change in Individuation Index at 1-month post-intervention
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Measured: Change from Baseline Score at 1-month post-intervention
Change in Individuation Index at 3-month post-intervention
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Measured: Change from Baseline Score at 3-month post-intervention
Secondary outcomes (9)
Arm Research Action Test (ARAT) Score at the immediate post-intervention time
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Tange: 0 - 57. Higher values correlate with better motor control.
Measured: Change from Baseline Score at 1-3 days post-intervention
Arm Research Action Test (ARAT) Score at at 1-month post-intervention
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Range: 0 - 57. Higher values correlate with better motor control.
Measured: Change from Baseline Score at 1-month post-intervention
Arm Research Action Test (ARAT) Score at at 3-month post-intervention
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Range: 0 - 57. Higher values correlate with better motor control.
Measured: Change from Baseline Score at 3-month post-intervention
Change in M1 MEP (motor evoked potentials) amplitude at immediate post-intervention time
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Measured: Change from Baseline Score at 1-3 days post-intervention
Change in M1 MEP (motor evoked potentials) amplitude at 1-month post-intervention
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Measured: Change from Baseline Score at 1-month post-intervention
Change in MEP (motor evoked potentials) amplitude at 3-months post-intervention
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Measured: Change from Baseline Score at 3-months post-intervention
Change in extent of SICI (short-interval cortical inhibition) at the immediate post-intervention time
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Measured: Change from Baseline Score at 1-3 days post-intervention
Change in extent of SICI (short-interval cortical inhibition) at 1-month post-intervention
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Measured: Change from Baseline Score at 1-month post-intervention
Change in extent of SICI (short-interval cortical inhibition) at 3-months post-intervention
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Measured: Change from Baseline Score at 3-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 May 2021
- Primary completion1 May 2024 (estimated)
- Study completion1 Mar 2026 (estimated)
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Principal investigator, Nachum Soroker, MD, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229329
- Sponsor's protocol ID
- LOE-19-19
- Status last verified
- Sep 2022
- First submitted
- 31 Dec 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intensive Training on Recovery of Fingers Dexterity Following Stroke: Behavioral, Physiological and Anatomical Predictors
- ClinicalTrials.gov ID
- NCT04229329
- Acronym / sponsor ID
- LOE-19-19
- Conditions
- Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 18 Jan 2020 (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 aim to test whether intensive training of finger individuation during the sensitive window of the subacute phases can lead to a clinically-meaningful recovery of dexterous movement in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Combination Product: Intensive Finger Individuation TherapyThe patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded visually and auditory when a higher degree of finger individuation will be measured. Specifically, when the applied force of the instructed fingers hit the predefined force target and at the same, the force in the non-instructed fingers stay as low as possible |
| Control | Sham comparator | Combination Product: Intensive non-directed finger movement therapyThe patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded in a way that is unrelated to the degree of individuation. In other words, a successful trial considered when the applied force of the instructed fingers hits the predefined force target regardless of the force exerted in the non-instructed fingers. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First symptomatic ischemic or hemorrhagic stroke
- Clinically evident upper-limb motor deficit
- Understand the study aim, is able to cooperate with the task for the specified time
- Clinically stable
Key exclusion criteria (6 listed)
- Other neurological or psychiatric illness which affects upper-limb motor function
- An orthopedic or rheumatologic disease that affects the ability to undergo a robotic hand therapy.
- Sensory problems that prevent the patient from reporting pain during the robotic hand therapy
- Skin breakdown or wounds located in places where the hand contacts the robot.
- Patients with C/I to TMS (history of seizures, the existence of cardiac pacer, VP shunt, spinal stimulator or any other hardware that may malfunction at the presence of strong magnetic fields) will no undergo TMS but may participate in the study
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 |
|---|---|---|
| Intensive Finger Individuation TherapyInteractive robot-mediated treatment aimed at increased individuation done repeatedly for at least1 hour per day for 2 weeks (5 training days a week). | Combination product | Intervention |
| Intensive non-directed finger movement therapyInteractive robot-mediated treatment not aimed specifically at increased individuation done repeatedly for at least 1 hour per day for 2 weeks (5 training days per week) | Combination product | Control |
Primary outcome
Change in Fugl-Meyer Assessment Score for Upper Extremity at the immediate post-intervention time
Time frame: Change from Baseline Score at 1-3 days post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Change in Fugl-Meyer Assessment Score for Upper Extermity at 1-month post-intervention
Time frame: Change from Baseline Score at 1 month post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Change in Fugl-Meyer Assessment Score for Upper Extermity at 3-month post-intervention
Time frame: Change from Baseline Score at 3 month post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Change in Individuation Index at the immediate post-intervention time
Time frame: Change from Baseline Score at 1-3 days post-intervention
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Change in Individuation Index at 1-month post-intervention
Time frame: Change from Baseline Score at 1-month post-intervention
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Change in Individuation Index at 3-month post-intervention
Time frame: Change from Baseline Score at 3-month post-intervention
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
9 secondary outcomes
Arm Research Action Test (ARAT) Score at the immediate post-intervention time
Time frame: Change from Baseline Score at 1-3 days post-intervention
Arm Research Action Test (ARAT) Score at at 1-month post-intervention
Time frame: Change from Baseline Score at 1-month post-intervention
Arm Research Action Test (ARAT) Score at at 3-month post-intervention
Time frame: Change from Baseline Score at 3-month post-intervention
Change in M1 MEP (motor evoked potentials) amplitude at immediate post-intervention time
Time frame: Change from Baseline Score at 1-3 days post-intervention
Change in M1 MEP (motor evoked potentials) amplitude at 1-month post-intervention
Time frame: Change from Baseline Score at 1-month post-intervention
Change in MEP (motor evoked potentials) amplitude at 3-months post-intervention
Time frame: Change from Baseline Score at 3-months post-intervention
Change in extent of SICI (short-interval cortical inhibition) at the immediate post-intervention time
Time frame: Change from Baseline Score at 1-3 days post-intervention
Change in extent of SICI (short-interval cortical inhibition) at 1-month post-intervention
Time frame: Change from Baseline Score at 1-month post-intervention
Change in extent of SICI (short-interval cortical inhibition) at 3-months post-intervention
Time frame: Change from Baseline Score at 3-months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intensive Finger Individuation Therapy and Intensive non-directed finger movement therapy in people with Stroke, run by Loewenstein Hospital at 1 site in Israel.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Sep 2022. 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shay Ofir-Geva, M.D. (972-522204842, shinofir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment Score for Upper Extremity at the immediate post-intervention time (time frame: Change from Baseline Score at 1-3 days post-intervention). The study lists 6 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 21 Sep 2022.