Rehabilitation ExerciseNCT05906875
A Novel Balance Program to Improve Balance in People With Parkinson's Disease
A study testing Lateral Stepping Exercise 1, Lateral Stepping Exercise 2 and Lateral Stepping Exercise 3 in people with Rehabilitation Exercise and Physical Therapy, run by New York Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Rehabilitation Exercise, Physical Therapy
- What is being tested?
- Lateral Stepping Exercise 1, Lateral Stepping Exercise 2 and Lateral Stepping Exercise 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Institute of Technology
Old Westbury, New York, 11568
About this study
Official title: A Novel Balance Program to Improve Balance in People With Parkinson's Disease: A Feasibility Study
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.
- Conditions
- Rehabilitation Exercise, Physical Therapy
- Being tested
- Lateral Stepping Exercise 1, Lateral Stepping Exercise 2, Lateral Stepping Exercise 3, Lateral Stepping Exercise 4, Lateral Stepping Exercise 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Stepping Exercise 1Other
- 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 2Other
- 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 3Other
- 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 4Other
- 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 5Other
- 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.
| Study group | Role | What they receive |
|---|---|---|
| prove feasible to integrate into an existing community group exercise program | Other | Prove feasible to integrate into an existing community group exercise program and Decrease the number of fall risk factors Receives: Other: Lateral Stepping Exercise 1; Other: Lateral Stepping Exercise 2; Other: Lateral Stepping Exercise 3; Other: Lateral Stepping Exercise 4; Other: Lateral Stepping Exercise 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mini-BESTest
Performance measure, validated in people with PD, aimed to target and identify 6 different balance control systems
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: approximately 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start20 Sep 2023
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Touro College and University System
- Responsible party
- Principal investigator, Michael Tautonico, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906875
- Sponsor's protocol ID
- BHS- IRB
- Status last verified
- Dec 2024
- First submitted
- 7 Jun 2023
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Balance Program to Improve Balance in People With Parkinson's Disease: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05906875
- Acronym / sponsor ID
- BHS- IRB
- Conditions
- Rehabilitation Exercise, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Collaborators
- The Touro College and University System
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prove feasible to integrate into an existing community group exercise program | Other | Other: Lateral Stepping Exercise 1, Other: Lateral Stepping Exercise 2, Other: Lateral Stepping Exercise 3, Other: Lateral Stepping Exercise 4, Other: Lateral Stepping Exercise 5Prove feasible to integrate into an existing community group exercise program and Decrease the number of fall risk factors |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral Stepping Exercise 11. 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. | Other | prove feasible to integrate into an existing community group exercise program |
| Lateral Stepping Exercise 22. 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. | Other | prove feasible to integrate into an existing community group exercise program |
| Lateral Stepping Exercise 33. 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. | Other | prove feasible to integrate into an existing community group exercise program |
| Lateral Stepping Exercise 44. 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. | Other | prove feasible to integrate into an existing community group exercise program |
| Lateral Stepping Exercise 55. 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. | Other | prove feasible to integrate into an existing community group exercise program |
Primary outcome
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 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral Stepping Exercise 1, Lateral Stepping Exercise 2 and Lateral Stepping Exercise 3 in people with Rehabilitation Exercise and Physical Therapy, run by New York Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mini-BESTest (time frame: 10-15 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.