LSVT BIG for Chronic Stroke Rehabilitation
1 other identifier
interventional
2
1 country
1
Brief Summary
This study aims to explore if the LSVT BIG® - a motor learning based treatment program designed for rehabilitation of people with Parkinson's disease could be beneficial for chronic stroke rehabilitation. A single-case experimental design with two adult participants, will be monitored for performance on self-selected goals before, during and after participating in the treatment program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2017
CompletedJune 26, 2017
June 1, 2017
4 months
June 13, 2017
June 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in perceived occupational performance
Positive change on performance score using the Canadian Occupational Performance Measure (COPM)
Administered weekly, for 6 weeks pre-intervention, 4 weeks during intervention and 5 post-intervention
Secondary Outcomes (3)
Perceived changes in upper extremity use
Administered weekly, for 6 weeks pre-intervention, 4 weeks during intervention and 5 post-intervention
Objective rating of activity performance
Administered at week 1 and week 10
Rating of upper extremity function
Administered at week 1 and week 10
Study Arms (1)
LSVT BIG intervention recipients
EXPERIMENTALParticipants participated in all of the evaluation steps as well as the LSVT BIG protocol which includes 16, 1-hour intervention sessions with a certified therapist performing, targeted exercises and activities to improve participation in occupations - with a focus on large amplitude movement.
Interventions
LSVT BIG is a motor learning based intervention 4 hour long sessions per week for 4 weeks following a specific protocol. Each session is composed of exercises and participant specific activities, as well as a homework program.
Eligibility Criteria
You may qualify if:
- stroke at least 6 months previously,
- communication in english or french,
- adequate cognition to follow direction and complete independent homework,
- independent mobility,
- medical stability,
- minimum Stage 3 for arm and hand on the Cherokee McMaster Stroke Assessment
You may not qualify if:
- dementia,
- psychiatric disorder,
- medical condition that would prevent participation in aerobic exercise.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Ottawa
Ottawa, Ontario, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Valerie Metcalfe
University of Ottawa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Outcome Assessor's for 2 of the outcome measures were blinded to the order of the pre and post assessment videos for rating, as well as being unfamiliar with the intervention protocol.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master's Candidate
Study Record Dates
First Submitted
June 13, 2017
First Posted
June 19, 2017
Study Start
July 4, 2016
Primary Completion
November 14, 2016
Study Completion
November 14, 2016
Last Updated
June 26, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share
No plan to share data.