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Clinical Trials/NCT05906875
NCT05906875
Completed
N/A

A Novel Balance Program to Improve Balance in People With Parkinson's Disease: A Feasibility Study

New York Institute of Technology1 site in 1 country5 target enrollmentSeptember 20, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rehabilitation Exercise
Sponsor
New York Institute of Technology
Enrollment
5
Locations
1
Primary Endpoint
The Four-Square Step Test
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

The purpose of this exploratory single-blinded feasibility study is to explore the effects of a lateral stepping program integrated into an existing community-based group exercise program for people with PD. The researchers hypothesize that participation in a lateral stepping program a minimum of 2 times/week for 8 weeks, in addition to RSB class participation is feasible in middle to late stage PD and will decrease fall risk factors. The researchers also hypothesize that the integration of this program into an existing community-based RSB program will be deemed feasible as shown by the number of sessions attended by each participant.

Registry
clinicaltrials.gov
Start Date
September 20, 2023
End Date
December 18, 2023
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Tautonico

Assistant Professor

New York Institute of Technology

Eligibility Criteria

Inclusion Criteria

  • A diagnosis of idiopathic PD stages II, III, or IV of the Hoehn and Yahr scale
  • 50-85 years inclusive
  • Subjects must be enrolled in RSB at NY Tech and attend at least 1 day per week for a minimum of 4 weeks prior to the first baseline assessment
  • English speaking.
  • Stable PD medication regime.

Exclusion Criteria

  • Any cardiovascular or other medical condition that would affect participation
  • Any hip and/or knee surgery or other injury that would prevent full participation in the intervention
  • Neurological conditions other than PD
  • Montreal Cognitive Assessment of ≤21
  • Pain that interferes with testing 13
  • Current participation in other strengthening, stretching or balance programs other than Rock Steady Boxing at NY Tech
  • Inability to understand and fully participate in this study

Outcomes

Primary Outcomes

The Four-Square Step Test

Time Frame: less than 5 minutes

Validated for people with PD is used to measure a patient's fall risk. The test requires a stopwatch and 4 canes laid in a cross pattern. The canes crossed pattern makeup 4 quadrants; quadrant 1 (bottom left), quadrant 2 (top left), quadrant 3 (top right), and quadrant 4 (bottom right). The subject is timed while they step clockwise, and then counterclockwise throughout the quadrants. An assistive device may be used.

The Activities Balance Confidence Scale

Time Frame: 5-10 minutes

Validated for people with PD, is a self-report measure of balance confidence while performing various common activities. Scale is from 0% to 100% with 100% being the most confident in their balance in a criterion.

The Mini-BESTest

Time Frame: 10-15 minutes

Performance measure, validated in people with PD, aimed to target and identify 6 different balance control systems

The Functional Gait Assessment

Time Frame: 5-20 minutes

Validated for people with PD is a performance measure validated in people with PD that is used to assess balance in the higher-functioning older adult and examines ambulation and the ability to perform motor tasks while ambulating

The Multidirectional Functional Reach Test

Time Frame: Less than 5 minutes

Used to assess stability when displacing a person's balance in a forward, lateral, and backward direction

The Parkinson's Disease Questionnaire-39

Time Frame: approximately 10 minutes

39-item self-administered questionnaire designed to assess 8 different quality-of-life domains. Uses a 5-point ordinal scale with 0 being never and 5 being always. Lower scores indicate a lower quality of life.

Study Sites (1)

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