Sit-to-Stand Training for Survivors of Stroke in a Long-T... | NCT00197509

Studies
Sit-to-Stand Training for Survivors of Stroke in a Long-Term Care Setting

NCT00197509

Sponsor

Hamilton Health Sciences Corporation

Status

Unknown status

Last Update Posted

Sep 20, 2005Estimated

Enrollment

120

Phase

Phase 2

Conditions

Cerebrovascular Accident

Interventions

Sit-To-Stand Protocol and Extra Practice in Sit-To-Stand

Countries

Canada

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

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

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

Sep 13, 2005

Last Update Posted Date

Sep 20, 2005Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hamilton Health Sciences CorporationOTHER

Collaborators

Name	Class
Ontario Ministry of Health and Long Term Care	OTHER_GOV

Description Module

Brief Summary

The purpose of this study is to see if providing training using a Sit-to-Stand protocol for residents of Long-Term Care Facilities who have had a stroke will increase their independence in performing Sit-to-Stand.

Detailed Description

The implementation of a sit-to-stand protocol and extra practice has been previously validated in a rehabilitation setting, where 68% of survivors of stroke who received the training, learned to stand safely and independently from a 16" surface (the height of a regular toilet). Our findings have been supported by other research that have shown that rising from sitting is a maneuver that has been advocated for strengthening the lower extremities of elderly individuals and patients with specific disorders such as stroke. During the acute care and rehabilitation phases, considerable effort is spent to maximize a person's functional abilities following a stroke; however, continued strengthening and activity appears to stop once an individual is admitted to a LTC facility.

The main purpose of this randomized controlled trial is to examine the efficacy of implementing the Sit-to-Stand (STS) protocol with or without extra sit-to-stand practice for survivors of stroke residing in Long-Term Care (LTC) facilities on (1) their ability to learn how to stand safely and independently from a 16" surface; (2) the number of staff injuries; (3) the number of residents' falls; (4) the quality of life of the residents and staff; and (5) the translation and maintenance of knowledge of the STS protocol by staff into their daily routines.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Sit-To-Stand Protocol and Extra Practice in Sit-To-Stand	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ability to independently perform Sit-To-Stand at 12 weeks and 24 weeks
Score on quality of life measure (COOP) at 12 and 24 weeks
Score on stroke assessment (CMSA) at 12 and 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of resident falls at 12 and 24 weeks
Number of staff injuries at 12 and 24 weeks
Knowledge of staff on STS protocol immediately post-training, 12 and 24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of cerebrovascular accident
Reside in Long-Term Care Facility
Have physician approval to participate in the study
Are unable to stand up independently from a 16" surface without using their hands
Have given informed consent

Exclusion Criteria:

Expect to be leaving the facility in less than 24 weeks
Have a terminal illness
Have a total hip replacement or other orthopedic complication that prevents them from being able to safely use protocol
Have pain that prevents their participation
Are at higher risk for falling (i.e. blood pressure disorder/postural hypotension, vestibular disorder)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan R Barreca, PT, BA	Hamilton Health Sciences Corporation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton Health Sciences, Chedoke Site		Hamilton	Ontario	L8N 3Z5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided