PC in Stance and During Functional Mobility Following BIG for PD

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877951
• Other study ID #: PC in PD after BIG
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: January 2017

Study information

• Verified date: May 2021
• Source: University of South Dakota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of South Dakota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Fullerton Advanced Balance Scale (FAB)	A change in higher level assessment of postural control is assessed.	Pre-Intervention (baseline) and Post-Intervention (week 5)
Primary	Functional and Multidirectional Reach Tests	A change in proactive postural control strategies is assessed.	Pre-Intervention (baseline) and Post-Intervention (week 5)
Primary	Center of Pressure measures (digitized walkway)	A change in the limits of stability is assessed.	Pre-Intervention (baseline) and Post-Intervention (week 5)