The Natural History of Recovery After Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorAdi Negev-Nahalat Eran
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
>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
Disqualifiers
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.
Trial population
Stroke survivors and healthy adults.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
non-interventional
Other interventionnon-interventional
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: Ofakim1 intervention
Group B: Haifa1 intervention
Group C: Hebron1 intervention
Trial outcomes
Primary outcomes
1
Fugl-Meyer Assessment (FMA)
Fugl-Meyer Assessment: Motor score is on a 0-100 scale. High score is better.
Time frame
Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year2
Action Research Arm Test (ARAT)
Action Research Arm Test Score is on a 0-57 scale. High score is better.
Time frame
Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year3
10-meter walk test (10MWT)
Outcome is the average walking velocity over 10 meters. Measured in m/sec.
Time frame
Baseline (<3weeks), 1-month, 3-month, 6-month, 1-yearSecondary outcomes
1
National Institutes of Health Stroke Scale (NIHSS)
measure of stroke severity on a 0-42 scale, with lower scores indicates lower severity (lower is better).
Time frame
Baseline (<3weeks)2
The Stroke Self-Efficacy Questionnaire (SSEQ)
This is a self-reported ability perception scale. Outcome range is 0-130 with higher scores indicate a better self-perceived ability.
Time frame
Baseline (<3weeks), 1-month, 3-month, 6-month, 1-year3
The Nine Hole Peg Test (NHPT)
This is an upper extremity dexterity test. Outcome is the time taken to complete the task. Measured in sec.
Time frame
Baseline (<3weeks), 1-year4
The Functional Dexterity Test (FDT)
This is an upper extremity dexterity test. Outcome is the time taken to complete the task. Measured in sec.
Time frame
Baseline (<3weeks), 1-yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Adi Negev-Nahalat Eran
Lead sponsor
Ben-Gurion University of the Negev
Collaborator
Technion, Israel Institute of Technology
Collaborator
Source ClinicalTrials.gov