Upper Limb Movement Quality Following Stroke

NCT06497881 | Recruiting

• 1 other identifier: NegevLab_2024_1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Hand movements-count

  The number of hand movements (count)

  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.

  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.

  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.

  One or two occasions over 1-6 hours each.

Secondary Outcomes (10)

• Fugl-Meyer Assessment (FMA)

  One occasions during the first month following recruitment.

• Action Research Arm Test (ARAT)

  One occasions during the first month following recruitment.

• Proprioception-1

  One occasions during the first month following recruitment.

• Proprioception-2

  One occasions during the first month following recruitment.

• Proprioception-3

  One occasions during the first month following recruitment.

Study Arms (2)

Stroke

Persons after a stroke. See inclusion/exclusion.

Controls

Healthy persons. See inclusion/exclusion.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persons with stroke and healthy adults.

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adi Negev-Nahalat Eran: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (1)

Adi-Negev Nahalat Eran

Ofakim, Israel

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Lior Smuelof, PhD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

• Yogev Koren, PhD

  Ben-Gurion University of the Negev

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lior Smuelof, PhD

CONTACT

972547510795; shmuelof@gmail.com

Yogev Koren, PhD

CONTACT

yogevk@post.bgu.ac.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 12, 2024
• Study Start: July 4, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Will be available with publication of results, indefinitely.
• Access Criteria: Open access.

Locations

IL (1)