Clinical trial NCT03602443: Feasibility of the Lee Silverman Voice Treatment®-BIG Intervention in Stroke
Official title: Feasibility of the Lee Silverman Voice Treatment®-BIG Intervention in Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Keywords: Upper Extremity Hemiparesis
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
First posted: 2018-07-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study is a randomized, wait-list, cross-over design pilot feasibility trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence Rate
timeFrame: 1 year
Secondary outcomes:
measure: Change from baseline in Wolf Motor Function Test (WMFT)
timeFrame: 4 weeks
measure: Change from baseline in Canadian Occupational Performance Measure (COPM)
timeFrame: 4 weeks
measure: Change from baseline in Performance Assessment of Self-Care Skills (PASS)
timeFrame: 4 weeks
measure: Change from baseline in PROMIS-43
timeFrame: 4 weeks
measure: Change from baseline in Modified Ashworth Scale (MAS)
timeFrame: 4 weeks
measure: Change from baseline in Upper Extremity Range of Motion
timeFrame: 4 weeks
measure: Change from baseline in Upper Extremity Strength
timeFrame: 4 weeks
measure: Retention Rate
timeFrame: 1 year
measure: Recruitment Rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
References:
citation: Ebersbach G, Ebersbach A, Gandor F, Wegner B, Wissel J, Kupsch A. Impact of physical exercise on reaction time in patients with Parkinson's disease-data from the Berlin BIG Study. Arch Phys Med Rehabil. 2014 May;95(5):996-9. doi: 10.1016/j.apmr.2013.10.020. Epub 2013 Nov 11.
citation: Ebersbach G, Grust U, Ebersbach A, Wegner B, Gandor F, Kuhn AA. Amplitude-oriented exercise in Parkinson's disease: a randomized study comparing LSVT-BIG and a short training protocol. J Neural Transm (Vienna). 2015 Feb;122(2):253-6. doi: 10.1007/s00702-014-1245-8. Epub 2014 May 29.
citation: Farley BG, Koshland GF. Training BIG to move faster: the application of the speed-amplitude relation as a rehabilitation strategy for people with Parkinson's disease. Exp Brain Res. 2005 Dec;167(3):462-7. doi: 10.1007/s00221-005-0179-7. Epub 2005 Nov 11.
citation: Gearing RE, El-Bassel N, Ghesquiere A, Baldwin S, Gillies J, Ngeow E. Major ingredients of fidelity: a review and scientific guide to improving quality of intervention research implementation. Clin Psychol Rev. 2011 Feb;31(1):79-88. doi: 10.1016/j.cpr.2010.09.007. Epub 2010 Oct 7.
citation: Lin KC, Hsieh YW, Wu CY, Chen CL, Jang Y, Liu JS. Minimal detectable change and clinically important difference of the Wolf Motor Function Test in stroke patients. Neurorehabil Neural Repair. 2009 Jun;23(5):429-34. doi: 10.1177/1545968308331144. Epub 2009 Mar 16.
citation: Proffitt RM, Henderson W, Scholl S, Nettleton M. Lee Silverman Voice Treatment BIG(R) for a Person With Stroke. Am J Occup Ther. 2018 Sep/Oct;72(5):7205210010p1-7205210010p6. doi: 10.5014/ajot.2018.028217.
citation: Winstein CJ, Wolf SL, Dromerick AW, Lane CJ, Nelsen MA, Lewthwaite R, Cen SY, Azen SP; Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Investigative Team. Effect of a Task-Oriented Rehabilitation Program on Upper Extremity Recovery Following Motor Stroke: The ICARE Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):571-81. doi: 10.1001/jama.2016.0276.
citation: Wolf SL, Catlin PA, Ellis M, Archer AL, Morgan B, Piacentino A. Assessing Wolf motor function test as outcome measure for research in patients after stroke. Stroke. 2001 Jul;32(7):1635-9. doi: 10.1161/01.str.32.7.1635.