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

Study Overview
=================
Brief Summary
-----------------
The purpose of this exploratory single-blinded randomized control trial 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, will decrease fall risk factors, increase balance confidence, and decrease fear of falling in participants in the experimental group compared to the control group. 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 and their satisfaction

Official Title
-----------------
A Novel Balance Program to Improve Balance in People With Parkinson's Disease: A Randomized Control Trial

Conditions
-----------------
Rehabilitation Exercise, Physical Therapy

Intervention / Treatment
-----------------
* Other: Lateral Stepping Exercise 1
* Other: Active Control Group Exercise 1
* Other: Active Control Group Exercise 2
* Other: Active Control Group Exercise 3
* Other: Active Control Group Exercise 4
* Other: Lateral Stepping Exercise 2
* Other: Lateral Stepping Exercise 3
* Other: Lateral Stepping Exercise 4
* Other: Lateral Stepping Exercise 5


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of idiopathic PD stages I, II, or III 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decrease fear of falling<br> | Other: Lateral Stepping Exercise 1<br>* 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.<br>Other: Active Control Group Exercise 1<br>* 1. Seated ankle movements (dorsi-/plantarflexion)hree sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 2<br>* 2. Knee extension Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 3<br>* 3. Hip flexion Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 4<br>* 4. Hip abduction Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Lateral Stepping Exercise 2<br>* 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.<br>Other: Lateral Stepping Exercise 3<br>* 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.<br>Other: Lateral Stepping Exercise 4<br>* 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.<br>Other: Lateral Stepping Exercise 5<br>* 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.<br>|
| Experimental: Decrease the number of fall risk factors<br> | Other: Lateral Stepping Exercise 1<br>* 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.<br>Other: Active Control Group Exercise 1<br>* 1. Seated ankle movements (dorsi-/plantarflexion)hree sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 2<br>* 2. Knee extension Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 3<br>* 3. Hip flexion Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 4<br>* 4. Hip abduction Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Lateral Stepping Exercise 2<br>* 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.<br>Other: Lateral Stepping Exercise 3<br>* 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.<br>Other: Lateral Stepping Exercise 4<br>* 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.<br>Other: Lateral Stepping Exercise 5<br>* 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.<br>|
| Experimental: Increase balance confidence<br> | Other: Lateral Stepping Exercise 1<br>* 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.<br>Other: Active Control Group Exercise 1<br>* 1. Seated ankle movements (dorsi-/plantarflexion)hree sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 2<br>* 2. Knee extension Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 3<br>* 3. Hip flexion Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 4<br>* 4. Hip abduction Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Lateral Stepping Exercise 2<br>* 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.<br>Other: Lateral Stepping Exercise 3<br>* 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.<br>Other: Lateral Stepping Exercise 4<br>* 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.<br>Other: Lateral Stepping Exercise 5<br>* 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.<br>|
| Experimental: prove feasible to integrate into an existing community group exercise program<br> | Other: Lateral Stepping Exercise 1<br>* 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.<br>Other: Active Control Group Exercise 1<br>* 1. Seated ankle movements (dorsi-/plantarflexion)hree sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 2<br>* 2. Knee extension Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 3<br>* 3. Hip flexion Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Active Control Group Exercise 4<br>* 4. Hip abduction Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.<br>Other: Lateral Stepping Exercise 2<br>* 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.<br>Other: Lateral Stepping Exercise 3<br>* 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.<br>Other: Lateral Stepping Exercise 4<br>* 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.<br>Other: Lateral Stepping Exercise 5<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mini-BESTest | Performance measure, validated in people with PD, aimed to target and identify 6 different balance control systems | 10-15 minutes | 
| The Functional Gait Assessment | 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 | 5-20 minutes | 
| The Multidirectional Functional Reach Test | Used to assess stability when displacing a person's balance in a forward, lateral, and backward direction | Less than 5 minutes | 
| The Four-Square Step Test | 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. | less than 5 minutes | 
| The Activities Balance Confidence Scale | 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. | 5-10 minutes | 
| The Parkinson's Disease Questionnaire-39 | 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. | approximately 10 minutes |