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Completed

NCT Number: NCT03602443

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

LSVT®BIG Intervention

Behavioral

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.

Waitlist Control

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change from baseline in Wolf Motor Function Test (WMFT)

    Time frame: 4 weeks

    Assessment of upper extremity motor function.

  2. 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.

  3. 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. 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).

  5. 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).

  6. Change from baseline in Upper Extremity Range of Motion

    Time frame: 4 weeks

    Angle (degrees) of the upper extremities as measured by a goniometer.

  7. Change from baseline in Upper Extremity Strength

    Time frame: 4 weeks

    Upper extremity strength will be assessed through Manual Muscle Testing.

  8. Retention Rate

    Time frame: 1 year

    Rate: Number of study participants completing the study relative to the number initially enrolled in the study

  9. 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • American Occupational Therapy Foundation

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2018
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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