Back to resultsA Novel Balance Program to Improve Balance in People With Parkinson's Disease
Primary Purpose
Rehabilitation Exercise, Physical Therapy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lateral Stepping Exercise 1
Active Control Group Exercise 1
Active Control Group Exercise 2
Active Control Group Exercise 3
Active Control Group Exercise 4
Lateral Stepping Exercise 2
Lateral Stepping Exercise 3
Lateral Stepping Exercise 4
Lateral Stepping Exercise 5
Sponsored by
About this trial
This is an interventional treatment trial for Rehabilitation Exercise
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Decrease fear of falling
Decrease the number of fall risk factors
Increase balance confidence
prove feasible to integrate into an existing community group exercise program
Arm Description
Outcomes
Primary Outcome Measures
The Mini-BESTest
Performance measure, validated in people with PD, aimed to target and identify 6 different balance control systems
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
The Multidirectional Functional Reach Test
Used to assess stability when displacing a person's balance in a forward, lateral, and backward direction
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05906875
First Posted
June 7, 2023
Last Updated
June 21, 2023
Sponsor
New York Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT05906875
Brief Title
A Novel Balance Program to Improve Balance in People With Parkinson's Disease
Official Title
A Novel Balance Program to Improve Balance in People With Parkinson's Disease: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Institute of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rehabilitation Exercise, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Decrease fear of falling
Arm Type
Experimental
Arm Title
Decrease the number of fall risk factors
Arm Type
Experimental
Arm Title
Increase balance confidence
Arm Type
Experimental
Arm Title
prove feasible to integrate into an existing community group exercise program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Lateral Stepping Exercise 1
Intervention Description
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
Intervention Name(s)
Active Control Group Exercise 1
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Active Control Group Exercise 2
Intervention Description
2. Knee extension Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.
Intervention Type
Other
Intervention Name(s)
Active Control Group Exercise 3
Intervention Description
3. Hip flexion Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.
Intervention Type
Other
Intervention Name(s)
Active Control Group Exercise 4
Intervention Description
4. Hip abduction Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.
Intervention Type
Other
Intervention Name(s)
Lateral Stepping Exercise 2
Intervention Description
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
Intervention Name(s)
Lateral Stepping Exercise 3
Intervention Description
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
Intervention Name(s)
Lateral Stepping Exercise 4
Intervention Description
4. Half-pelvic drop: The participant stands on both legs with one knee straight and the other knee bent to approximately 45 degrees. Participants will be instructed to drop their pelvis (hip) on the side with the bent knee, then raise it as high as possible. Support is used as needed. This exercise will be performed for 3 sets with each set stopping when an RPE of 5-7 is reported.
Intervention Type
Other
Intervention Name(s)
Lateral Stepping Exercise 5
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Mini-BESTest
Description
Performance measure, validated in people with PD, aimed to target and identify 6 different balance control systems
Time Frame
10-15 minutes
Title
The Functional Gait Assessment
Description
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
Time Frame
5-20 minutes
Title
The Multidirectional Functional Reach Test
Description
Used to assess stability when displacing a person's balance in a forward, lateral, and backward direction
Time Frame
Less than 5 minutes
Title
The Four-Square Step Test
Description
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.
Time Frame
less than 5 minutes
Title
The Activities Balance Confidence Scale
Description
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.
Time Frame
5-10 minutes
Title
The Parkinson's Disease Questionnaire-39
Description
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.
Time Frame
approximately 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
A Novel Balance Program to Improve Balance in People With Parkinson's Disease
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