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

University of Missouri-Columbia5 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Stroke

Interventions

LSVT®BIG InterventionBEHAVIORAL

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 ControlBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Missouri

Columbia, Missouri, United States

Outcomes

Primary Outcomes

Adherence Rate

For each study participant, an percentage of clinic visits and home exercises completed will be calculated. Rates will be averaged within groups.

Time frame: 1 year

Secondary Outcomes

Change from baseline in Wolf Motor Function Test (WMFT)

Assessment of upper extremity motor function.

Time frame: 4 weeks

Change from baseline in Canadian Occupational Performance Measure (COPM)

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.

Time frame: 4 weeks

Change from baseline in Performance Assessment of Self-Care Skills (PASS)

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.

Time frame: 4 weeks

Change from baseline in PROMIS-43

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).

Time frame: 4 weeks

Change from baseline in Modified Ashworth Scale (MAS)

Assess muscle tone of various joints. Only joints with any spasticity will be recorded. Scale ranges from 0 (no spasticity) to 3 (rigid joint).

Time frame: 4 weeks

Change from baseline in Upper Extremity Range of Motion

Data from ClinicalTrials.gov

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