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

NCT ID: NCT05906875

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2023-12-18

Brief Summary

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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.

Detailed Description

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Conditions

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Rehabilitation Exercise Physical Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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prove feasible to integrate into an existing community group exercise program

Prove feasible to integrate into an existing community group exercise program and Decrease the number of fall risk factors

Group Type OTHER

Lateral Stepping Exercise 1

Intervention Type OTHER

1\. Standing hip abduction: Performed without and with resistance bands and/or support. The participant will raise one leg out to the side and return. If using a resistance band, one end of the band will be secured to a stable surface and the other end placed around one of the participants' ankles. The banded leg will be raised to the side. Three sets of 8-12 repetitions will be performed per side.

Lateral Stepping Exercise 2

Intervention Type OTHER

2\. Lateral stepping: Performed without and with resistance bands. The participant will perform a series of steps to the side. If using a resistance band, the band will be placed around both ankles in a 'loop' and the participant will perform the lateral stepping. Three sets of 8-12 repetitions will be performed per side per subject.

Lateral Stepping Exercise 3

Intervention Type OTHER

3\. Single leg stance: The participant will stand on one leg with support as needed. The contralateral knee will be held at 45 degrees throughout the exercise. The instructor will observe to ensure the bent leg does not contact the ground. Three repetitions of static stance per side will be performed with a goal of 30 seconds, and a maximum time of 60 seconds, per repetition.

Lateral Stepping Exercise 4

Intervention Type OTHER

4\. Staggered stance mini-squat: Participants will stand with the feet hip-width apart and one leg placed a short step forward. The participant will squat straight down keeping the trunk upright and return to an upright position.

Lateral Stepping Exercise 5

Intervention Type OTHER

5\. Lateral Reactive Postural Control: The participant will lean into the researcher's hand to shift their center of mass outside of their base of support. Hand placement will be at the glenohumeral joint and the pelvis. The researcher will withdraw support and guard the participant as the participant regains their balance. This is item 6 on the Mini-BESTest assessment that will be incorporated as an intervention. To be performed 3x per side.

Interventions

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Lateral Stepping Exercise 1

1\. Standing hip abduction: Performed without and with resistance bands and/or support. The participant will raise one leg out to the side and return. If using a resistance band, one end of the band will be secured to a stable surface and the other end placed around one of the participants' ankles. The banded leg will be raised to the side. Three sets of 8-12 repetitions will be performed per side.

Intervention Type OTHER

Lateral Stepping Exercise 2

2\. Lateral stepping: Performed without and with resistance bands. The participant will perform a series of steps to the side. If using a resistance band, the band will be placed around both ankles in a 'loop' and the participant will perform the lateral stepping. Three sets of 8-12 repetitions will be performed per side per subject.

Intervention Type OTHER

Lateral Stepping Exercise 3

3\. Single leg stance: The participant will stand on one leg with support as needed. The contralateral knee will be held at 45 degrees throughout the exercise. The instructor will observe to ensure the bent leg does not contact the ground. Three repetitions of static stance per side will be performed with a goal of 30 seconds, and a maximum time of 60 seconds, per repetition.

Intervention Type OTHER

Lateral Stepping Exercise 4

4\. Staggered stance mini-squat: Participants will stand with the feet hip-width apart and one leg placed a short step forward. The participant will squat straight down keeping the trunk upright and return to an upright position.

Intervention Type OTHER

Lateral Stepping Exercise 5

5\. Lateral Reactive Postural Control: The participant will lean into the researcher's hand to shift their center of mass outside of their base of support. Hand placement will be at the glenohumeral joint and the pelvis. The researcher will withdraw support and guard the participant as the participant regains their balance. This is item 6 on the Mini-BESTest assessment that will be incorporated as an intervention. To be performed 3x per side.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. A diagnosis of idiopathic PD stages II, III, or IV of the Hoehn and Yahr scale
2. 50-85 years inclusive
3. 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
4. English speaking.
5. Stable PD medication regime.

Exclusion Criteria

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

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Touro College and University System

OTHER

Sponsor Role collaborator

New York Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Michael Tautonico

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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New York Institute of Technology

Old Westbury, New York, United States

Site Status

Countries

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United States

Other Identifiers

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BHS- IRB

Identifier Type: -

Identifier Source: org_study_id