Independence Stairs Climbing Ability Prediction During th... | NCT03742674

Studies
Independence Stairs Climbing Ability Prediction During the Sub-acute Rehabilitation Phase of People After Stroke

NCT03742674

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Nov 20, 2018Actual

Enrollment

45Estimated

Phase

Not provided

Conditions

Interventions

Follow up

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2018Estimated

Primary Completion Date

Nov 2020Estimated

Completion Date

Nov 2020Estimated

First Submitted Date

Nov 8, 2018

First Submission Date that Met QC Criteria

Nov 14, 2018

First Posted Date

Nov 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2018

Last Update Posted Date

Nov 20, 2018Actual

Name	Class
Tel Aviv University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Independence stairs climbing ability prediction during the sub-acute rehabilitation phase of people after stroke

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort patients post stroke			Other: Follow up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follow up	Other	No intervention	Cohort patients post stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Independently climbing stairs ability	Yes / No	Through study completion, an average of 1-2 years

Secondary Outcomes

Measure	Description	Time Frame
Time post stroke	Days	Through study completion, an average of 1-2 years
Time for ascending and descending staircase	Seconds	Through study completion, an average of 1-2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First cerebro vascular accident (CVA) diagnosis
Basic cognitive and communicative abilities

Exclusion Criteria:

Traumatic brain injury (TBI)
Confusion state and lack of cooperation due to brain lesion
Unstable cardiovascular status
Independently climbing stairs ability at entrance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Post stroke Age 18-69 years Hospitalized in brain injury rehabilitation at Sheba Tel-Hashomer medical center

Sampling Method

Non-Probability Sample