LSVT BIG for Chronic Stroke Rehabilitation

LSVT BIG for Chronic Stroke Rehabilitation: a Single-Case Experimental Design

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.

Study Overview

• Status: Completed
• Conditions: Chronic Stroke
• Intervention / Treatment: Behavioral: LSVT BIG

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • University of Ottawa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LSVT BIG intervention recipients; 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.	Behavioral: LSVT BIG; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Administered weekly, for 6 weeks pre-intervention, 4 weeks during intervention and 5 post-intervention
Objective rating of activity performance	Positive change in objective rating of activity performance using the Performance Quality Rating Scale- Operational Definition (PQRS-OD),	Administered at week 1 and week 10
Rating of upper extremity function	Positive change in upper extremity function as measured by the Chedoke Arm and Hand Activity Inventory-13(CAHAI-13)	Administered at week 1 and week 10

Collaborators and Investigators

• Sponsor: University of Ottawa
• Investigators: Principal Investigator: Valerie Metcalfe, University of Ottawa

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2016
• Primary Completion (Actual): November 14, 2016
• Study Completion (Actual): November 14, 2016

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 23, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; Occupational Performance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: H03-16-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No