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

Cerebrovascular Accident Clinical Trial

Official title:

Task Specific Training for Stroke Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00197509
• Other study ID #: 04-359
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: January 2005
• Est. completion date: February 2006

Study information

• Verified date: September 2005
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Behavioral:
• Sit-To-Stand Protocol and Extra Practice in Sit-To-Stand

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences, Chedoke Site	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to independently perform Sit-To-Stand at 12 weeks and 24 weeks
Primary	Score on quality of life measure (COOP) at 12 and 24 weeks
Primary	Score on stroke assessment (CMSA) at 12 and 24 weeks
Secondary	Number of resident falls at 12 and 24 weeks
Secondary	Number of staff injuries at 12 and 24 weeks
Secondary	Knowledge of staff on STS protocol immediately post-training, 12 and 24 weeks
Secondary	Score on quality of life measure (SF-20) at 12 and 24 weeks