PC in Stance and During Functional Mobility Following BIG for PD
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LSVT BIG
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring postural control, gait
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Effect of LSVT BIG therapy on Postural Control and Gait Parameters
Arm Description
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.
Outcomes
Primary Outcome Measures
Mini Balance Evaluation Systems Test (Mini-BESTest)
A change in reactive, proactive, and sensory contributions to postural control (balance) is assessed.
Fullerton Advanced Balance Scale (FAB)
A change in higher level assessment of postural control is assessed.
Functional and Multidirectional Reach Tests
A change in proactive postural control strategies is assessed.
Center of Pressure measures (digitized walkway)
A change in the limits of stability is assessed.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04877951
Brief Title
PC in Stance and During Functional Mobility Following BIG for PD
Official Title
Postural Control in Stance and During Functional Mobility Following Management of Parkinson's Disease With LSVT BIG Training
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Dakota
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
postural control, gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Effect of LSVT BIG therapy on Postural Control and Gait Parameters
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LSVT BIG
Intervention Description
LSVT BIG is a 4-week program that focuses on movement recalibration for people with a diagnosis of Parkinson's disease.
Primary Outcome Measure Information:
Title
Mini Balance Evaluation Systems Test (Mini-BESTest)
Description
A change in reactive, proactive, and sensory contributions to postural control (balance) is assessed.
Time Frame
Pre-Intervention (baseline) and Post-Intervention (week 5)
Title
Fullerton Advanced Balance Scale (FAB)
Description
A change in higher level assessment of postural control is assessed.
Time Frame
Pre-Intervention (baseline) and Post-Intervention (week 5)
Title
Functional and Multidirectional Reach Tests
Description
A change in proactive postural control strategies is assessed.
Time Frame
Pre-Intervention (baseline) and Post-Intervention (week 5)
Title
Center of Pressure measures (digitized walkway)
Description
A change in the limits of stability is assessed.
Time Frame
Pre-Intervention (baseline) and Post-Intervention (week 5)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patti J Berg-Poppe, PhD
Organizational Affiliation
University of South Dakota
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
PC in Stance and During Functional Mobility Following BIG for PD
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