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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Stroke

Intervention / Treatment
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* Behavioral: LSVT®BIG Intervention
* Behavioral: Waitlist Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study is a randomized, wait-list, cross-over design pilot feasibility trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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<br>* 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.<br>Behavioral: Waitlist Control<br>* 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.<br>|
| Other: Waitlist Control<br>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<br>* 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.<br>Behavioral: Waitlist Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence Rate | 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) | Assessment of upper extremity motor function. | 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. | 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. | 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). | 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). | 4 weeks | 
| Change from baseline in Upper Extremity Range of Motion | Angle (degrees) of the upper extremities as measured by a goniometer. | 4 weeks | 
| Change from baseline in Upper Extremity Strength | Upper extremity strength will be assessed through Manual Muscle Testing. | 4 weeks | 
| Retention Rate | Rate: Number of study participants completing the study relative to the number initially enrolled in the study | 1 year | 
| Recruitment Rate | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper Extremity Hemiparesis