Clinical trial NCT06497881: Upper Limb Movement Quality Following Stroke
Official title: Monitoring Post Stroke Upper-Limb Movement in The Wild
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: Adi Negev-Nahalat Eran
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2024-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with stroke and healthy adults.

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.

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.

Primary outcomes:
measure: Hand movements-count
timeFrame: One or two occasions over 1-6 hours each.
measure: Hand movements-duration
timeFrame: One or two occasions over 1-6 hours each.
measure: Active joint range
timeFrame: One or two occasions over 1-6 hours each.
measure: Wrist distance
timeFrame: One or two occasions over 1-6 hours each.
Secondary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: One occasions during the first month following recruitment.
measure: Action Research Arm Test (ARAT)
timeFrame: One occasions during the first month following recruitment.
measure: Proprioception-1
timeFrame: One occasions during the first month following recruitment.
measure: Proprioception-2
timeFrame: One occasions during the first month following recruitment.
measure: Proprioception-3
timeFrame: One occasions during the first month following recruitment.
measure: Joint range of motion
timeFrame: One or two occasions over 1-6 hours each.
measure: Synergies
timeFrame: One or two occasions over 1-6 hours each.
measure: Angular velocity.
timeFrame: One or two occasions over 1-6 hours each.
measure: Movement volume
timeFrame: One or two occasions over 1-6 hours each.
measure: Whole body movement time
timeFrame: One or two occasions over 1-6 hours each.
Other outcomes:
Locations:
city: Ofakim
country: Israel
facility: Adi-Negev Nahalat Eran
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Lior Smuelof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ben-Gurion University of the Negev
name: Yogev Koren, PhD
role: PRINCIPAL_INVESTIGATOR
References: