PC in Stance and During Functional Mobi… | Clinical Trial

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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. Postural instability and gait disturbance is another debilitating feature of Parkinson's disease. While LSVT BIG targets postural correction through exercises which challenge balance, the effect of this intervention on stability margins and functional balance assessments have not been well established in the literature. This study includes outcome measures not previously examined with this intervention and may provide valuable evidence regarding the impact of this intervention on postural control, balance and falls risk. Alternative amplitude programs have also been designed to meet the needs of patients with PD. These programs adjust frequencies for patients and individualize sessions more than LSVT BIG. We are interested in knowing if these alternative frequencies and amplitude approaches are similarly as effective as LSVT BIG in our outcome measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria: 1) previous completion of LSVT BIG or other formal amplitude program training 2) non-idopathic Parkinsonism 3) any medical condition that would contraindicate exercise (ie. unstable cardiovascular disease) 4) cognitive impairment that limits ability to follow direction or demonstration

Treatment and study plan

LSVT BIG

Behavioral

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

Primary outcomes

Mini Balance Evaluation Systems Test (Mini-BESTest)

Time frame: Pre-Intervention (baseline) and Post-Intervention (week 5)

A change in reactive, proactive, and sensory contributions to postural control (balance) is assessed.
Fullerton Advanced Balance Scale (FAB)

Time frame: Pre-Intervention (baseline) and Post-Intervention (week 5)

A change in higher level assessment of postural control is assessed.
Functional and Multidirectional Reach Tests

Time frame: Pre-Intervention (baseline) and Post-Intervention (week 5)

A change in proactive postural control strategies is assessed.
Center of Pressure measures (digitized walkway)

Time frame: Pre-Intervention (baseline) and Post-Intervention (week 5)

A change in the limits of stability is assessed.

Sponsors and collaborators

Lead sponsor

University of South Dakota

Other

Registry information

Official study title

Postural Control in Stance and During Functional Mobility Following Management of Parkinson's Disease With LSVT BIG Training

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: May 7, 2021
Registry last updated: May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed