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RecruitingNCT06497881Updated Oct 3, 2025

Upper Limb Movement Quality Following Stroke

An observational study in Stroke, sponsored by Adi Negev-Nahalat Eran. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by Adi Negev-Nahalat Eran · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 40 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Adi Negev-Nahalat Eran is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Persons with stroke and healthy adults.

Inclusion criteria

  • >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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Stroke

    Persons after a stroke. See inclusion/exclusion.

  • Controls

    Healthy persons. See inclusion/exclusion.

06

What researchers measure

Primary outcomes

  1. Hand movements-count

    The number of hand movements (count)

    Time frame: One or two occasions over 1-6 hours each.

  2. Hand movements-duration

    The total and average (per hour) time the hands moved, over the tested period. Measured in minutes.

    Time frame: One or two occasions over 1-6 hours each.

  3. Active joint range

    Maximum, minimum, and mean range of motion of the joints during daily activity. Measured in degrees/radians.

    Time frame: One or two occasions over 1-6 hours each.

  4. Wrist distance

    The maximum, average and total distance of the wrist from the body during movements. Measured in cm.

    Time frame: One or two occasions over 1-6 hours each.

Secondary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Fugl-Meyer Assessment: Motor score of the upper limb is on a 0-66 scale. High score is better.

    Time frame: One occasions during the first month following recruitment.

  2. Action Research Arm Test (ARAT)

    Action Research Arm Test Score is on a 0-57 scale. High score is better.

    Time frame: One occasions during the first month following recruitment.

  3. 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.

    Time frame: One occasions during the first month following recruitment.

  4. 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).

    Time frame: One occasions during the first month following recruitment.

  5. Proprioception-3

    Delay between hand movement initiation observed kinematical (acceleration) and kinetically (EMG signal). Measured in msec.

    Time frame: One occasions during the first month following recruitment.

  6. Joint range of motion

    Maximum and minimum joints range of motion (active and passive). Measured in degrees/radians.

    Time frame: One or two occasions over 1-6 hours each.

  7. 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).

    Time frame: One or two occasions over 1-6 hours each.

  8. Angular velocity.

    Maximum and average angular velocity of the joints during daily activity. Measured in degrees/radians per second

    Time frame: One or two occasions over 1-6 hours each.

  9. Movement volume

    Volume occupied by the limb segments calculated using the 3D location of the joints. Measured in cm\^3.

    Time frame: One or two occasions over 1-6 hours each.

  10. Whole body movement time

    The total and average (per hour) time of movements of the whole body. Measured in minutes.

    Time frame: One or two occasions over 1-6 hours each.

07

Study locations

1 of 1 sites recruiting
  • Adi-Negev Nahalat Eran
    Ofakim, Israel
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication.

Supporting information: Study protocol, Sap, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06497881
Lead sponsor
Adi Negev-Nahalat Eran
Collaborators
Ben-Gurion University of the Negev
Responsible party
Sponsor
First posted
Jul 12, 2024
Start date
Jul 4, 2024
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Oct 3, 2025

Study contacts

Lior Smuelof, PhD
Contact
shmuelof@gmail.com
972547510795
Yogev Koren, PhD
Contact
yogevk@post.bgu.ac.il
Lior Smuelof, PhD
principal investigator · Ben-Gurion University of the Negev
Yogev Koren, PhD
principal investigator · Ben-Gurion University of the Negev

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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