CVANCT03742674
Independence Stairs Climbing Ability Prediction During the Sub-acute Rehabilitation Phase of People After Stroke
An observational study of CVA, run by Sheba Medical Center.
Trial summary
Independence stairs climbing ability prediction during the sub-acute rehabilitation phase of people after stroke Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- CVA
- What is being tested?
- Follow up
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post stroke Age 18-69 years Hospitalized in brain injury rehabilitation at Sheba Tel-Hashomer medical center
Who may be able to join
- First cerebro vascular accident (CVA) diagnosis
- Basic cognitive and communicative abilities
Who cannot join
- Traumatic brain injury (TBI)
- Confusion state and lack of cooperation due to brain lesion
- Unstable cardiovascular status
- Independently climbing stairs ability at entrance
About this study
Independence stairs climbing ability prediction during the sub-acute rehabilitation phase of people after stroke
- Conditions
- CVA
- Being tested
- Follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow upOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Cohort patients post stroke | Not described Receives: Other: Follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independently climbing stairs ability
Yes / No
Measured: Through study completion, an average of 1-2 years
Secondary outcomes (3)
Time post stroke
Days
Measured: Through study completion, an average of 1-2 years
Time for ascending and descending staircase
Seconds
Measured: Through study completion, an average of 1-2 years
Stairs climbing tipe
Step over / Step to, use of handrail
Measured: Through study completion, an average of 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVAStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742674
- Sponsor's protocol ID
- SHEBA-18-5299-OK-CTIL
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independence Stairs Climbing Ability Prediction During the Sub-acute Rehabilitation Phase of People After Stroke
- ClinicalTrials.gov ID
- NCT03742674
- Acronym / sponsor ID
- SHEBA-18-5299-OK-CTIL
- Conditions
- CVA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- Nov 2018 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Independence stairs climbing ability prediction during the sub-acute rehabilitation phase of people after stroke
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort patients post stroke | – | Other: Follow up |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post stroke Age 18-69 years Hospitalized in brain injury rehabilitation at Sheba Tel-Hashomer medical center
Key inclusion criteria (2 listed)
- First cerebro vascular accident (CVA) diagnosis
- Basic cognitive and communicative abilities
Key exclusion criteria (4 listed)
- Traumatic brain injury (TBI)
- Confusion state and lack of cooperation due to brain lesion
- Unstable cardiovascular status
- Independently climbing stairs ability at entrance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow upNo intervention | Other | Cohort patients post stroke |
Primary outcome
Independently climbing stairs ability
Time frame: Through study completion, an average of 1-2 years
Yes / No
3 secondary outcomes
Time post stroke
Time frame: Through study completion, an average of 1-2 years
Time for ascending and descending staircase
Time frame: Through study completion, an average of 1-2 years
Stairs climbing tipe
Time frame: Through study completion, an average of 1-2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of CVA, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independently climbing stairs ability (time frame: Through study completion, an average of 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.