University of Missouri
Columbia, Missouri, 65211, United States
NCT Number: NCT03602443
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Columbia, Missouri, 65211, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 4 weeks
Assessment of upper extremity motor function.
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.
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.
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).
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).
Time frame: 4 weeks
Angle (degrees) of the upper extremities as measured by a goniometer.
Time frame: 4 weeks
Upper extremity strength will be assessed through Manual Muscle Testing.
Time frame: 1 year
Rate: Number of study participants completing the study relative to the number initially enrolled in the study
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.
University of Missouri-Columbia
Other
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