Stroke Clinical Trial
Official title:
Comparing the Behavior of the Cardiac Autonomic Regulation System During 24h in Patient Post Stroke and Controls
By Investigating the heart rate variability (HRV) of 15 patients after stroke and compare it
to the HRV of 15 orthopedic patients, the investigators hope to achieve 3 main goals:
1. To describe the 24-hour circadian rhythm of heart rate among patients after stroke in the
sub-acute phase during 3 days. 2. To examine the differences in the circadian rhythm of
heart rate along 3 days between patients after stroke in the sub-acute phase and control
group matched by age and gender. 3. To describe the reaction and examine the differences in
reactions of the heart autonomic system during rest, paced breathing and activity in both
groups- stoke and control.
The HRV will be monitored by Polar watch and the activity will be measured by accelerometer,
both will be attached to the patients at the beginning of the trial and will stay on them
for 3 whole days.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years to 85 Years |
Eligibility |
Inclusion Criteria: - First stroke - 1-3 weeks after the stroke Exclusion Criteria: - Pacemaker - Cardiac arrhythmia - Use of Beta- Blocker drugs - Cerebellar deficit - Mini-Mental State Examination (MMSE) < 18 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | heart rate variability | Heart rate variability will be measured by Polar watch at the beginning of each day during the 3 days of the research. At the end of those days, the data will be collected and analyzed on computer software. | 3 days | No |
Primary | step counter | Step counter by Polar loop. Stored in the device and transfer to a computer for analysis. | three days follow up, (24-hours X 3) | No |
Secondary | Stroke activity Scale | A 5 items scale who measures the motor function at the level of disability in stroke patients. The functions included are getting out of bed, static and dynamic sitting balance, sitting to standing, stepping and walking and bringing a glass to the mouth. | At admission | No |
Secondary | Scandinavian Stroke Scale | A 9 items scale (consciousness; eye movements; arm motor power; hand motor power; leg motor power; orientation; speech; facial palsy and gait) to assess neurological status. | At admission | No |
Secondary | Functional Independence Measure | 18 items scale designed to assess the amount of assistance required for a person with a disability to perform basic life activities safely and effectively. The activities include a mini- mum set of skills related to self-care, sphincter control, trans- fers, locomotion, communication, and social cognition. | At admission | No |
Secondary | Autonomic function questionnaire | Based on the Svedberg questionnaire, originally made for children with cerebral palsy (CP) to describe symptoms such as cold extremities, constipation, pain, sleeping disorders and impaired well-being | At admission | No |
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