NCT04877951

Brief Summary

LSVT BIG is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of Parkinson's disease, specifically bradykinesia. We are interested in knowing the effects of this therapeutic approach on postural control and gait parameters.

Trial Health

100
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 parkinson-disease

Timeline
Completed

Started Mar 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

April 28, 2021

Last Update Submit

May 4, 2021

Conditions

Parkinson Disease

Keywords

postural controlgait

Outcome Measures

Primary Outcomes (4)

  • Mini Balance Evaluation Systems Test (Mini-BESTest)

    A change in reactive, proactive, and sensory contributions to postural control (balance) is assessed.

    Pre-Intervention (baseline) and Post-Intervention (week 5)

  • Fullerton Advanced Balance Scale (FAB)

    A change in higher level assessment of postural control is assessed.

    Pre-Intervention (baseline) and Post-Intervention (week 5)

  • Functional and Multidirectional Reach Tests

    A change in proactive postural control strategies is assessed.

    Pre-Intervention (baseline) and Post-Intervention (week 5)

  • Center of Pressure measures (digitized walkway)

    A change in the limits of stability is assessed.

    Pre-Intervention (baseline) and Post-Intervention (week 5)

Study Arms (1)

Effect of LSVT BIG therapy on Postural Control and Gait Parameters

OTHER

LSVT BIG is a commonly used protocol to manage functional movement for those with Parkinson's Disease. This study measured postural control and gait parameters following a 4-week course of LSVT BIG therapy.

Behavioral: LSVT BIG

Interventions

LSVT BIGBEHAVIORAL

LSVT BIG is a 4-week program that focuses on movement recalibration for people with a diagnosis of Parkinson's disease.

Effect of LSVT BIG therapy on Postural Control and Gait Parameters

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be included in the study if they have been diagnosed with idiopathic Parkinson's disease and are English speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Patti J Berg-Poppe, PhD

    University of South Dakota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2021

First Posted

May 7, 2021

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

January 1, 2017

Last Updated

May 7, 2021

Record last verified: 2021-05