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

University of Missouri (MU)

Status: Completed

Conditions: Chronic Stroke

Treatments: Behavioral: LSVT®BIG Intervention; Behavioral: Waitlist Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03602443

2011132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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5 participants in 2 patient groups

Experimental

Experimental group

Description:

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).

Treatment:

Behavioral: LSVT®BIG Intervention

Behavioral: Waitlist Control

Waitlist Control

Other group

Description:

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

Treatment:

Behavioral: LSVT®BIG Intervention

Behavioral: Waitlist Control