NCT00197509

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

September 20, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Cerebrovascular Accident

Keywords

Long-Term CareClinical ProtocolsSit-To-Stand

Outcome Measures

Primary Outcomes (3)

  • 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 (4)

  • 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

  • Score on quality of life measure (SF-20) at 12 and 24 weeks

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences, Chedoke Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Susan R Barreca, PT, BA

    Hamilton Health Sciences Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2005

Study Completion

February 1, 2006

Last Updated

September 20, 2005

Record last verified: 2005-09

Locations

CA(1)