Learning the Natural History of Recovery After Stroke - Cognitive, Motor and Sensory Function

Adi Negev-Nahalat Eran3 sites in 2 countries200 target enrollmentFebruary 1, 2024

ConditionsCerebral Vascular Accident (CVA)/Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cerebral Vascular Accident (CVA)/Stroke
Sponsor: Adi Negev-Nahalat Eran
Enrollment: 200
Locations: 3
Primary Endpoint: Fugl-Meyer Assessment (FMA)
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this longitudinal observational study is to learn the course of recovery after stroke. Specifically, in this study we will learn and describe the changes in cognitive, motor and sensory function over time in stroke patients.

Detailed Description

This study constitutes the first step in the RESTRO project: Evaluation of an accessible and affordable neurorehabilitation program to promote recovery and to enhance the quality of life after stroke. In this study, we will monitor sensorimotor and cognitive functions of Stroke patients along the first 6 to 12 month following their stroke. Data from three primary sites will be collected and compared in several time points, and its relation to the type and intensity of the rehabilitation program, usually provided in each site, will be tested.

Registry

clinicaltrials.gov

Start Date

February 1, 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, with first ever stroke, or with a recurrent stroke that did not lead to disability (were independent in ADL before the second stroke).
•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.
•Participation in another interventional study.

Outcomes

Primary Outcomes

Fugl-Meyer Assessment (FMA)

Time Frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

Fugl-Meyer Assessment: Motor score is on a 0-100 scale. High score is better.

Action Research Arm Test (ARAT)

Time Frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

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

10-meter walk test (10MWT)

Time Frame: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year

Outcome is the average walking velocity over 10 meters. Measured in m/sec.

Secondary Outcomes

The Stroke Self-Efficacy Questionnaire (SSEQ)(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
The Ashworth scale(Baseline (<3weeks))
Supporting data-age(Baseline)
Supporting data-time2(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
supporting data-medical history(Baseline)
Cognition-inhibition2(one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
National Institutes of Health Stroke Scale (NIHSS)(Baseline (<3weeks))
The Nine Hole Peg Test (NHPT)(Baseline (<3weeks), 1-year)
The Functional Dexterity Test (FDT)(Baseline (<3weeks), 1-year)
The Behavioral Inattention Test (BIT)(Baseline (<3weeks))
Kinetics-fingers1(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Kinematics-Inter-joint coordination(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Rehabilitation-intensity(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Rehabilitation-time(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Supporting data-sex(Baseline)
anthropometric data-height(Baseline)
supporting data-directional(Baseline)
Cognition-impairment(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Gaze-downward(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Kinetics-fingers2(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Kinetics-grip(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Kinematics-reaching(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Kinematics-duration(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Kinematics-smoothness(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Rehabilitation-period(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Supporting data-time1(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
anthropometric data-weight(Baseline)
Cognition-inhibition1(one or more of : Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Gait Specific attentional profile (G-SAP)(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Gait analysis-spatial(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Gait analysis-steadiness(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Gaze-angle2(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Gaze-look-ahead distance(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Muscle controllability1(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Muscle controllability3(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Timed up and Go test (TUG)(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Gait analysis-temporal(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Gaze-angle1(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Balance-Berg(baseline)
Balance-postural steadiness1(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Balance-postural steadiness3(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Habitual activity1(one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Balance-postural steadiness2(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Balance-postural steadiness4(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Habitual activity2(one or more of :Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Sensory-tactile(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Coordination-LE1(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Coordination-LE2(Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Reticulospinal excitability(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Muscle controllability2(one or more of: Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year)
Neuroimaging(one or more of :1-month, 3-month, 6-month, 1-year)