Feasibility of the Lee Silverman Voice Treatment®-BIG Intervention in Stroke

March 23, 2020 updated by: Rachel Proffitt, University of Missouri-Columbia
Evaluate feasibility (acceptability, subject recruitment/retention, willingness to be randomized, and adherence rates) of delivering the Lee Silverman Voice Treatment®-BIG (LSVT®BIG) intervention with individuals with chronic stroke. Evaluate preliminary effect of the LSVT®BIG intervention on motor function and occupational performance with individuals with chronic stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Literature suggests the Lee Silverman Voice Treatment®-BIG (LSVT-BIG®) program is an effective intervention for individuals with Parkinson's Disease (Ebersbach et al., 2015); however, no literature or research exists on the use of this program as an intervention for individuals with stroke. Therefore, this project aims to measure the effectiveness of the LSVT®BIG program with one individual with a stroke to determine if LSVT®BIG is a feasible and effective occupational therapy intervention for this population. The LSVT®BIG program is an intensive program with hands-on treatment sessions 4 days per week for 4 weeks. Clients complete home exercises every day that enhance the hands-on treatment and help promote carry-over of skills learned to daily tasks. The investigators have completed two case studies with clients with chronic stroke who demonstrated improved outcomes in upper extremity motor function and occupational performance. The purpose of this study is to test the LSVT®BIG intervention with a larger clinical population and to demonstrate that LSVT®BIG is an effective and feasible treatment option for improvement in occupational performance and upper extremity motor function with individuals with stroke.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • 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

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 or older
  2. Diagnosis of first-ever ischemic stroke at least 6 months prior as confirmed by medical records
  3. Has more than a moderate stroke (NIH Stroke Scale > 20)
  4. Can read and write English. To ensure participants can understand instructions in clinic and home exercise sessions

Exclusion Criteria:

  1. More than moderate motor deficits (Fugl-Meyer UE Assessment < 32/66)
  2. More than mild cognitive impairment (Mini-Mental Status Examination < 24)
  3. More than mild balance deficits (Berg Balance Scale <45)
  4. Minimal or no impairments from their stroke (NIH Stroke Scale < 6)
  5. Currently receiving occupational therapy or physical therapy services
  6. Has had more than one stroke

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: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental
This group will receive the LSVT(R)BIG Intervention first (4 weeks) and then cross over to the Waitlist Control (no intervention for 4 weeks).
Behavioral: LSVT®BIG Intervention
Participants will complete LSVT®BIG intervention which consists of 16 one-hour sessions on 4 consecutive days for 4 weeks, and a home program component.
Behavioral: Waitlist Control
Participants randomized to this arm will be followed for the 4-week time period. We will track engagement in any daily exercise (not therapy services) through self-report.
OTHER: Waitlist Control
This group will receive the Waitlist Control (4 weeks) and then cross over to receive the LSVT(R)BIG Intervention (4 weeks).
Behavioral: LSVT®BIG Intervention
Participants will complete LSVT®BIG intervention which consists of 16 one-hour sessions on 4 consecutive days for 4 weeks, and a home program component.
Behavioral: Waitlist Control
Participants randomized to this arm will be followed for the 4-week time period. We will track engagement in any daily exercise (not therapy services) through self-report.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence Rate
Time Frame: 1 year
For each study participant, an percentage of clinic visits and home exercises completed will be calculated. Rates will be averaged within groups.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Wolf Motor Function Test (WMFT)
Time Frame: 4 weeks
Assessment of upper extremity motor function.
4 weeks
Change from baseline in Canadian Occupational Performance Measure (COPM)
Time Frame: 4 weeks
The Canadian occupational Performance Measure is a measure of the subject's self-rated performance and satisfaction of their performance with 5 self-identified areas of occupation/activities.
4 weeks
Change from baseline in Performance Assessment of Self-Care Skills (PASS)
Time Frame: 4 weeks
The Performance Assessment of Self-Care Skills (PASS) assesses basic self-care and instrumental activities of daily living. Subscales: Independence, Safety, Adequacy (minimum: 0, maximum: 3). There is no total score reported.
4 weeks
Change from baseline in PROMIS-43
Time Frame: 4 weeks
General assessment of quality of life and participation in daily life. Assessment is from the standardized NIH Toolbox. T-scores are reported on scale of 0-100 (50 is average).
4 weeks
Change from baseline in Modified Ashworth Scale (MAS)
Time Frame: 4 weeks
Assess muscle tone of various joints. Only joints with any spasticity will be recorded. Scale ranges from 0 (no spasticity) to 3 (rigid joint).
4 weeks
Change from baseline in Upper Extremity Range of Motion
Time Frame: 4 weeks
Angle (degrees) of the upper extremities as measured by a goniometer.
4 weeks
Change from baseline in Upper Extremity Strength
Time Frame: 4 weeks
Upper extremity strength will be assessed through Manual Muscle Testing.
4 weeks
Retention Rate
Time Frame: 1 year
Rate: Number of study participants completing the study relative to the number initially enrolled in the study
1 year
Recruitment Rate
Time Frame: 1 year
A log of calls will be kept. The number of screened study participants relative to the total number of calls made will be used to calculate recruitment rate.
1 year

Collaborators and Investigators

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

Sponsor

University of Missouri-Columbia

Collaborators

American Occupational Therapy Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 6, 2018

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

June 19, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (ACTUAL)

July 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All de-identified clinical outcome assessment data with accompanying key will be deposited in MOspace Institutional Repository, the University of Missouri's digital institutional repository. MOspace is based on MIT's DSpace technology and is a joint venture of the University of Missouri's Division of Information Technology and the University Libraries. MOspace items will include appropriate metadata and a permanent URL. Items will be freely available via the MOspace web site at https://mospace.umsystem.edu and will be searchable via Google and other search engines.

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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