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

Not Applicable

Completed

• Conditions: Chronic Stroke
• Interventions: Behavioral: LSVT®BIG Intervention; Behavioral: Waitlist Control

• Registration Number: NCT03602443
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Study Start: 2018-08-06
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental	LSVT®BIG Intervention	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).
Waitlist Control	LSVT®BIG Intervention	This group will receive the Waitlist Control (4 weeks) and then cross over to receive the LSVT(R)BIG Intervention (4 weeks).
Experimental	Waitlist Control	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).
Waitlist Control	Waitlist Control	This group will receive the Waitlist Control (4 weeks) and then cross over to receive the LSVT(R)BIG Intervention (4 weeks).

Primary Outcome Measures

Name	Time	Method
Adherence Rate	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 Outcome Measures

Name	Time	Method
Retention Rate	1 year	Rate: Number of study participants completing the study relative to the number initially enrolled in the study
Change from baseline in Canadian Occupational Performance Measure (COPM)	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.
Change from baseline in PROMIS-43	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).
Change from baseline in Upper Extremity Range of Motion	4 weeks	Angle (degrees) of the upper extremities as measured by a goniometer.
Change from baseline in Wolf Motor Function Test (WMFT)	4 weeks	Assessment of upper extremity motor function.
Change from baseline in Performance Assessment of Self-Care Skills (PASS)	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.
Change from baseline in Modified Ashworth Scale (MAS)	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).
Change from baseline in Upper Extremity Strength	4 weeks	Upper extremity strength will be assessed through Manual Muscle Testing.
Recruitment Rate	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.

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States