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

Chronic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602443
• Other study ID #: 2011132
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Behavioral:
• LSVT®BIG Intervention
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.
• Waitlist Control
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.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	American Occupational Therapy Foundation

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

Ebersbach G, Grust U, Ebersbach A, Wegner B, Gandor F, Kühn 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. Erratum in: J Neural Transm (Vienna). 2015 Feb;122(2):257. — View 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. Epub 2005 Nov 11. — View 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. Review. — View 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. — View Citation

Proffitt R, Henderson W, Scholl S, Nettleton M. Lee Silverman Voice Treatment- BIG® to improve occupational performance in stroke. American Journal of Occupational Therapy. In press.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in Wolf Motor Function Test (WMFT)	Assessment of upper extremity motor function.	4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in Upper Extremity Range of Motion	Angle (degrees) of the upper extremities as measured by a goniometer.	4 weeks
Secondary	Change from baseline in Upper Extremity Strength	Upper extremity strength will be assessed through Manual Muscle Testing.	4 weeks
Secondary	Retention Rate	Rate: Number of study participants completing the study relative to the number initially enrolled in the study	1 year
Secondary	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