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NCT Number: NCT06497881

Upper Limb Movement Quality Following Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Adi-Negev Nahalat Eran

Ofakim, Israel

Location status: Recruiting

Location contact

Lior Smuelof, PhD

PRINCIPAL_INVESTIGATOR

Shilo Kramer, MD

CONTACT

[email protected]

Simona Bar-Haim, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. Hand movements-count

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

    The number of hand movements (count)

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Fugl-Meyer Assessment (FMA)

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

    Fugl-Meyer Assessment:

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

  2. Action Research Arm Test (ARAT)

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

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

  3. Proprioception-1

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

    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.

  4. Proprioception-2

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

    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).

  5. Proprioception-3

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

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

  6. Joint range of motion

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

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

  7. Synergies

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

    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).

  8. Angular velocity.

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

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

  9. Movement volume

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

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

  10. Whole body movement time

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lior Smuelof, PhD

CONTACT

[email protected]

972547510795

Yogev Koren, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Adi Negev-Nahalat Eran

Other

Collaborators

  • Ben-Gurion University of the Negev

Registry information

Official study title

Monitoring Post Stroke Upper-Limb Movement in The Wild

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 12, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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