LSVT BIG for Chronic Stroke Rehabilitation

June 23, 2017 updated by: Valerie Metcalfe, University of Ottawa

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in perceived occupational performance
Time Frame: Administered weekly, for 6 weeks pre-intervention, 4 weeks during intervention and 5 post-intervention
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived changes in upper extremity use
Time Frame: Administered weekly, for 6 weeks pre-intervention, 4 weeks during intervention and 5 post-intervention
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
Time Frame: Administered at week 1 and week 10
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
Time Frame: Administered at week 1 and week 10
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ottawa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Valerie Metcalfe, University of Ottawa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 4, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 14, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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