LSVT BIG for Chronic Stroke Rehabilitation
Primary Purpose
Chronic Stroke
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
LSVT BIG
Sponsored by

About this trial
This is an interventional treatment trial for Chronic Stroke focused on measuring Rehabilitation, Occupational Performance
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- dementia,
- psychiatric disorder,
- medical condition that would prevent participation in aerobic exercise.
Sites / Locations
- University of Ottawa
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LSVT BIG intervention recipients
Arm Description
Participants 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.
Outcomes
Primary Outcome Measures
Change in perceived occupational performance
Positive change on performance score using the Canadian Occupational Performance Measure (COPM)
Secondary Outcome Measures
Perceived changes in upper extremity use
Positive change in perceived upper extremity use using the Rating of Everyday Arm-Use in the Community and Home (REACH)
Objective rating of activity performance
Positive change in objective rating of activity performance using the Performance Quality Rating Scale- Operational Definition (PQRS-OD),
Rating of upper extremity function
Positive change in upper extremity function as measured by the Chedoke Arm and Hand Activity Inventory-13(CAHAI-13)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03191422
Brief Title
LSVT BIG for Chronic Stroke Rehabilitation
Official Title
LSVT BIG for Chronic Stroke Rehabilitation: a Single-Case Experimental Design
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 4, 2016 (Actual)
Primary Completion Date
November 14, 2016 (Actual)
Study Completion Date
November 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ottawa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Over 700 000 Canadians are living with the effects of stroke. Approximately 60% of people living with the effects of stroke need help with every day activities and 84% are limited in the activities which they would like to participate in. Much research has focused on interventions for acute and sub-acute rehabilitation but it is also known that gains can still be made in the chronic stage. Among common rehabilitation interventions to reduce impairment, there is moderate evidence of effectiveness of constraint induced movement therapy (CIMT) and mirror therapy and weak evidence of effectiveness of repetitive task training. However, positive effects on impairment do not necessarily carryover into activities of daily living.
Therefore, an intervention program with a goal of improvement in occupational performance outside of the clinical setting, one that targets everyday activities and participant selected activities, would be a valuable tool for occupational therapy post stroke. The objective of this study was to explore whether the LSVT BIG® program, an intervention targeting participant-identified functional goals which includes strategies to encourage generalization to other tasks, could be applicable to the rehabilitation of the chronic effects of stroke.
LSVT BIG is a time limited, high intensity rehabilitation program designed to be used by occupational therapists or physiotherapists to target Parkinson's disease motor symptoms of bradykinesia and hypokinesia, in an outpatient environment, with a goal of improving function. This intervention involves exercises and repetitive practice of patient-selected activities with a focus on big (increased amplitude) movements. It is believed that this will lead to normally paced and sized movements which will generalize to untrained activities.
Although Parkinson's disease and stroke have different pathological mechanisms, the elements in the LSVT BIG program are based on the same neuroplasticity and motor learning principles that form the basis for stroke rehabilitation methods. What is novel, however, is the focus on amplitude and just one cue, 'big', for all difficult movement situations, potentially increasing generalizability outside of the clinical setting and trained activities.
The LSVT BIG program uses motor learning principles of blocked practice, serial practice and elements of random practice (varying environmental factors), extrinsic feedback (including verbal feedback, modeling, shaping and focus on knowledge of results) as well as a single external, knowledge of results focused cue 'big' to encourage adaptation, recalibration of the internal motor program of the movement, and transfer to other tasks. LSVT BIG also respects the neuroplasticity principles of intensity, repetition, specificity and saliency The aim of this study is to begin to explore the effectiveness of LSVT BIG in late stroke rehabilitation.
The primary hypothesis is that participants with chronic stroke will demonstrate improvement in trained activities following LSVT BIG.
A secondary hypothesis is that participants will also improve in untrained activities due to carryover of the intervention effects.
Study Design A single-case experimental design (SCED) with one replication was used . An A-B-A design was selected and included a baseline phase, an intervention phase, and a post-intervention phase. Perceived performance and satisfaction with performance of participant-selected activities, and self-report of everyday upper extremity use were the outcomes subjected to repeated measures. In addition, pre- and post- measures of observed performance quality and upper extremity function were carried out.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
Rehabilitation, Occupational Performance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-Case experimental design One repetition
Masking
None (Open Label)
Masking Description
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.
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LSVT BIG intervention recipients
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Behavioral
Intervention Name(s)
LSVT BIG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in perceived occupational performance
Description
Positive change on performance score using the Canadian Occupational Performance Measure (COPM)
Time Frame
Administered weekly, for 6 weeks pre-intervention, 4 weeks during intervention and 5 post-intervention
Secondary Outcome Measure Information:
Title
Perceived changes in upper extremity use
Description
Positive change in perceived upper extremity use using the Rating of Everyday Arm-Use in the Community and Home (REACH)
Time Frame
Administered weekly, for 6 weeks pre-intervention, 4 weeks during intervention and 5 post-intervention
Title
Objective rating of activity performance
Description
Positive change in objective rating of activity performance using the Performance Quality Rating Scale- Operational Definition (PQRS-OD),
Time Frame
Administered at week 1 and week 10
Title
Rating of upper extremity function
Description
Positive change in upper extremity function as measured by the Chedoke Arm and Hand Activity Inventory-13(CAHAI-13)
Time Frame
Administered at week 1 and week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
dementia,
psychiatric disorder,
medical condition that would prevent participation in aerobic exercise.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Metcalfe
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data.
Learn more about this trial
LSVT BIG for Chronic Stroke Rehabilitation
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