NCT03602443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

August 6, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

June 19, 2018

Last Update Submit

March 23, 2020

Conditions

Chronic Stroke

Keywords

Upper Extremity Hemiparesis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change from baseline in Wolf Motor Function Test (WMFT)

    4 weeks

  • Change from baseline in Canadian Occupational Performance Measure (COPM)

    4 weeks

  • Change from baseline in Performance Assessment of Self-Care Skills (PASS)

    4 weeks

  • Change from baseline in PROMIS-43

    4 weeks

  • Change from baseline in Modified Ashworth Scale (MAS)

    4 weeks

  • +4 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

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).

Behavioral: LSVT®BIG InterventionBehavioral: Waitlist Control

Waitlist Control

OTHER

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

Behavioral: LSVT®BIG InterventionBehavioral: Waitlist Control

Interventions

LSVT®BIG InterventionBEHAVIORAL

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.

ExperimentalWaitlist Control
Waitlist ControlBEHAVIORAL

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.

ExperimentalWaitlist Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Diagnosis of first-ever ischemic stroke at least 6 months prior as confirmed by medical records
  • Has more than a moderate stroke (NIH Stroke Scale \> 20)
  • Can read and write English. To ensure participants can understand instructions in clinic and home exercise sessions

You may not qualify if:

  • More than moderate motor deficits (Fugl-Meyer UE Assessment \< 32/66)
  • More than mild cognitive impairment (Mini-Mental Status Examination \< 24)
  • More than mild balance deficits (Berg Balance Scale \<45)
  • Minimal or no impairments from their stroke (NIH Stroke Scale \< 6)
  • Currently receiving occupational therapy or physical therapy services
  • Has had more than one stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Related 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.

    PMID: 24231400BACKGROUND

  • 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.

    PMID: 24872078BACKGROUND

  • 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.

    PMID: 16283401BACKGROUND

  • 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.

    PMID: 21130938BACKGROUND

  • 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.

    PMID: 19289487BACKGROUND

  • 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.

    PMID: 30157019BACKGROUND

  • 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.

    PMID: 26864411BACKGROUND

  • 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.

    PMID: 11441212BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The study is a randomized, wait-list, cross-over design pilot feasibility trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 19, 2018

First Posted

July 26, 2018

Study Start

August 6, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

All de-identified clinical outcome assessment data with accompanying key will be deposited in MOspace Institutional Repository, the University of Missouri's digital institutional repository. MOspace is based on MIT's DSpace technology and is a joint venture of the University of Missouri's Division of Information Technology and the University Libraries. MOspace items will include appropriate metadata and a permanent URL. Items will be freely available via the MOspace web site at https://mospace.umsystem.edu and will be searchable via Google and other search engines.

Locations

US(1)