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Chronic StrokeNCT03602443

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

A study testing LSVT®BIG Intervention in people with Chronic Stroke, run by University of Missouri-Columbia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Stroke
What is being tested?
LSVT®BIG Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
6 Aug 2018to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Missouri

    Columbia, Missouri, 65211

Other trials in United States

About this study

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.

Read the 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.

Conditions
Chronic Stroke
Being tested
LSVT®BIG Intervention, Waitlist Control
Keywords
Upper Extremity Hemiparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LSVT®BIG InterventionBehavioural

    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 ControlBehavioural

    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.

Study groups in NCT03602443
Study groupRoleWhat they receive
ExperimentalExperimentalThis group will receive the LSVT(R)BIG Intervention first (4 weeks) and then cross over to the Waitlist Control (no intervention for 4 weeks).
Receives: Behavioral: LSVT®BIG Intervention; Behavioral: Waitlist Control
Waitlist ControlOtherThis group will receive the Waitlist Control (4 weeks) and then cross over to receive the LSVT(R)BIG Intervention (4 weeks).
Receives: Behavioral: LSVT®BIG Intervention; Behavioral: Waitlist Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (9)

  1. Change from baseline in Wolf Motor Function Test (WMFT)

    Assessment of upper extremity motor function.

    Measured: 4 weeks

  2. 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.

    Measured: 4 weeks

  3. 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.

    Measured: 4 weeks

  4. 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).

    Measured: 4 weeks

  5. 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).

    Measured: 4 weeks

  6. Change from baseline in Upper Extremity Range of Motion

    Angle (degrees) of the upper extremities as measured by a goniometer.

    Measured: 4 weeks

  7. Change from baseline in Upper Extremity Strength

    Upper extremity strength will be assessed through Manual Muscle Testing.

    Measured: 4 weeks

  8. Retention Rate

    Rate: Number of study participants completing the study relative to the number initially enrolled in the study

    Measured: 1 year

  9. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start6 Aug 2018
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
The study is a randomized, wait-list, cross-over design pilot feasibility trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03602443
Sponsor's protocol ID
2011132
Status last verified
Mar 2020
First submitted
19 Jun 2018
Last updated
24 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 24231400

  • 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.

    PubMed 24872078

  • 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.

    PubMed 16283401

  • 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.

    PubMed 21130938

  • 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.

    PubMed 19289487

  • 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.

    PubMed 30157019

  • 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.

    PubMed 26864411

  • 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.

    PubMed 11441212

Questions about this trial

What is this clinical trial studying?

A study testing LSVT®BIG Intervention in people with Chronic Stroke, run by University of Missouri-Columbia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03602443, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.

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