StrokeNCT06497881
Upper Limb Movement Quality Following Stroke
An observational study of Stroke, run by Adi Negev-Nahalat Eran at 1 site in Israel.
Trial summary
The aim of this study is to monitor the daily upper limb movement of persons with stroke, and to relate these quantities to measures of recovery and impairment. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 4 Jul 2024to 1 Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Persons with stroke and healthy adults.
Who may be able to join
- >18 years of age
- Independent in all activities of daily living before the stroke.
- In- and out-patients at Adi-Negev Nahalat-Eran rehabilitation center.
- Medically stable
- Able to provide informed consent.
Who cannot join
- The presence of any degenerative neurological condition, neuropathy, myopathy or Polio that are not secondary to stroke, excluding diabetic related changes.
- Traumatic brain injury and/or extra-cerebral hemorrhage.
- Significant psychiatric condition, including alcoholism and drug abuse.
- Any severe orthopedic condition (such as amputation or severe pain that limits activity) or chronic pain syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yogev Koren, PhD contact
Israel1 site, 1 recruiting
- Recruiting
Adi-Negev Nahalat Eran
Ofakim
Shilo Kramer, MD, shilok@adi-il.org
Simona Bar-Haim, PhD, barhaims@bgu.ac.il
About this study
Official title: Monitoring Post Stroke Upper-Limb Movement in The Wild
The aim of this study is to monitor the daily upper limb movement of persons with stroke, and to relate these quantities to measures of recovery and impairment.
Read the detailed description
This study is part of The Natural History of Stroke Recovery project. In this study the investigators plan to develop, test and validate an algorithm and software for using Inertial Measuring Units (IMUs) to monitor upper limb daily movement. Then, investigators plan to use this system to monitor such activity in stroke patients.
Investigators also plan to develop, test and validate an algorithm and software to test proprioception acuity based on muscle synergy during active and passive movement. Muscle synergy will be determined based on muscles' electrical activity, as measured using surface electromyography (EMG).
Investigators will then test the relation between daily movements of the upper limb in stroke patients, and their recovery/impairment levels, including proprioception acuity.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Persons after a stroke. See inclusion/exclusion. | |
| Controls | Healthy persons. See inclusion/exclusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand movements-count
The number of hand movements (count)
Measured: One or two occasions over 1-6 hours each.
Hand movements-duration
The total and average (per hour) time the hands moved, over the tested period. Measured in minutes.
Measured: One or two occasions over 1-6 hours each.
Active joint range
Maximum, minimum, and mean range of motion of the joints during daily activity. Measured in degrees/radians.
Measured: One or two occasions over 1-6 hours each.
Wrist distance
The maximum, average and total distance of the wrist from the body during movements. Measured in cm.
Measured: One or two occasions over 1-6 hours each.
Secondary outcomes (10)
Fugl-Meyer Assessment (FMA)
Fugl-Meyer Assessment:
Motor score of the upper limb is on a 0-66 scale. High score is better.
Measured: One occasions during the first month following recruitment.
Action Research Arm Test (ARAT)
Action Research Arm Test Score is on a 0-57 scale. High score is better.
Measured: One occasions during the first month following recruitment.
Proprioception-1
The difference between joint angles in an angle matching task. E.g., matching the shoulder angle of a passively moved arm with the contralateral arm. Angles include both anatomical angles and elevation angles. Measured in degrees/radians.
Measured: One occasions during the first month following recruitment.
Proprioception-2
Parameters of the correlation (regression) between EMG signals during active and passive movement. Including the constant (in mV), slope (arbitrary units) and R^2 (arbitrary units).
Measured: One occasions during the first month following recruitment.
Proprioception-3
Delay between hand movement initiation observed kinematical (acceleration) and kinetically (EMG signal). Measured in msec.
Measured: One occasions during the first month following recruitment.
Joint range of motion
Maximum and minimum joints range of motion (active and passive). Measured in degrees/radians.
Measured: One or two occasions over 1-6 hours each.
Synergies
Parameters of the correlation (regression) between the kinematic signals of the different upper extremity segments. Including the slope (arbitrary units) and R^2 (arbitrary units).
Measured: One or two occasions over 1-6 hours each.
Angular velocity.
Maximum and average angular velocity of the joints during daily activity. Measured in degrees/radians per second
Measured: One or two occasions over 1-6 hours each.
Movement volume
Volume occupied by the limb segments calculated using the 3D location of the joints. Measured in cm^3.
Measured: One or two occasions over 1-6 hours each.
Whole body movement time
The total and average (per hour) time of movements of the whole body. Measured in minutes.
Measured: One or two occasions over 1-6 hours each.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start4 Jul 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Adi Negev-Nahalat Eran
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Sponsor
- Investigators
- Lior Smuelof, PhD, Principal investigator, Ben-Gurion University of the NegevYogev Koren, PhD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497881
- Sponsor's protocol ID
- NegevLab_2024_1
- Status last verified
- Sep 2025
- First submitted
- 1 Jul 2024
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Post Stroke Upper-Limb Movement in The Wild
- ClinicalTrials.gov ID
- NCT06497881
- Acronym / sponsor ID
- NegevLab_2024_1
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Adi Negev-Nahalat EranUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 12 Jul 2024 (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 aim of this study is to monitor the daily upper limb movement of persons with stroke, and to relate these quantities to measures of recovery and impairment.
Detailed description
This study is part of The Natural History of Stroke Recovery project. In this study the investigators plan to develop, test and validate an algorithm and software for using Inertial Measuring Units (IMUs) to monitor upper limb daily movement. Then, investigators plan to use this system to monitor such activity in stroke patients.
Investigators also plan to develop, test and validate an algorithm and software to test proprioception acuity based on muscle synergy during active and passive movement. Muscle synergy will be determined based on muscles' electrical activity, as measured using surface electromyography (EMG).
Investigators will then test the relation between daily movements of the upper limb in stroke patients, and their recovery/impairment levels, including proprioception acuity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | –Persons after a stroke. See inclusion/exclusion. |
| Controls | – | –Healthy persons. See inclusion/exclusion. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with stroke and healthy adults.
Key inclusion criteria (5 listed)
- >18 years of age
- Independent in all activities of daily living before the stroke.
- In- and out-patients at Adi-Negev Nahalat-Eran rehabilitation center.
- Medically stable
- Able to provide informed consent.
Key exclusion criteria (4 listed)
- The presence of any degenerative neurological condition, neuropathy, myopathy or Polio that are not secondary to stroke, excluding diabetic related changes.
- Traumatic brain injury and/or extra-cerebral hemorrhage.
- Significant psychiatric condition, including alcoholism and drug abuse.
- Any severe orthopedic condition (such as amputation or severe pain that limits activity) or chronic pain syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hand movements-count
Time frame: One or two occasions over 1-6 hours each.
The number of hand movements (count)
Hand movements-duration
Time frame: One or two occasions over 1-6 hours each.
The total and average (per hour) time the hands moved, over the tested period. Measured in minutes.
Active joint range
Time frame: One or two occasions over 1-6 hours each.
Maximum, minimum, and mean range of motion of the joints during daily activity. Measured in degrees/radians.
Wrist distance
Time frame: One or two occasions over 1-6 hours each.
The maximum, average and total distance of the wrist from the body during movements. Measured in cm.
10 secondary outcomes
Fugl-Meyer Assessment (FMA)
Time frame: One occasions during the first month following recruitment.
Action Research Arm Test (ARAT)
Time frame: One occasions during the first month following recruitment.
Proprioception-1
Time frame: One occasions during the first month following recruitment.
Proprioception-2
Time frame: One occasions during the first month following recruitment.
Proprioception-3
Time frame: One occasions during the first month following recruitment.
Joint range of motion
Time frame: One or two occasions over 1-6 hours each.
Synergies
Time frame: One or two occasions over 1-6 hours each.
Angular velocity.
Time frame: One or two occasions over 1-6 hours each.
Movement volume
Time frame: One or two occasions over 1-6 hours each.
Whole body movement time
Time frame: One or two occasions over 1-6 hours each.
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 3 Oct 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
Related trials for Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
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.
Yogev Koren, PhD contact
Lior Smuelof, PhD principal investigator
Ben-Gurion University of the Negev
Yogev Koren, PhD principal investigator
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Adi Negev-Nahalat Eran 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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. 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?
Contact Lior Smuelof, PhD (972547510795, shmuelof@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand movements-count (time frame: One or two occasions over 1-6 hours each.). The study lists 4 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 3 Oct 2025.