Skip to main content
Clinical Trials/NCT06497881
NCT06497881
Recruiting
Not Applicable

Monitoring Post Stroke Upper-Limb Movement in The Wild

Adi Negev-Nahalat Eran1 site in 1 country40 target enrollmentJuly 4, 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Adi Negev-Nahalat Eran
Enrollment
40
Locations
1
Primary Endpoint
Active joint range
Status
Recruiting
Last Updated
7 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 4, 2024
End Date
January 1, 2027
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Adi Negev-Nahalat Eran
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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

  • Proprioception-1(One occasions during the first month following recruitment.)
  • Angular velocity.(One or two occasions over 1-6 hours each.)
  • Action Research Arm Test (ARAT)(One occasions during the first month following recruitment.)
  • Joint range of motion(One or two occasions over 1-6 hours each.)
  • Synergies(One or two occasions over 1-6 hours each.)
  • Whole body movement time(One or two occasions over 1-6 hours each.)
  • Proprioception-2(One occasions during the first month following recruitment.)
  • Fugl-Meyer Assessment (FMA)(One occasions during the first month following recruitment.)
  • Proprioception-3(One occasions during the first month following recruitment.)
  • Movement volume(One or two occasions over 1-6 hours each.)

Study Sites (1)

Loading locations...

Similar Trials