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

Sponsor
New York Institute of Technology (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05906875
Collaborator
(none)
30
4
12

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Novel Balance Program to Improve Balance in People With Parkinson's Disease: A Randomized Control Trial
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Decrease fear of falling

Other: 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.

Other: Active Control Group Exercise 1
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.

Other: Active Control Group Exercise 2
2. Knee extension Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

Other: Active Control Group Exercise 3
3. Hip flexion Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

Other: Active Control Group Exercise 4
4. Hip abduction Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

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.

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.

Other: Lateral Stepping Exercise 4
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.

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.

Experimental: Decrease the number of fall risk factors

Other: 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.

Other: Active Control Group Exercise 1
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.

Other: Active Control Group Exercise 2
2. Knee extension Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

Other: Active Control Group Exercise 3
3. Hip flexion Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

Other: Active Control Group Exercise 4
4. Hip abduction Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

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.

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.

Other: Lateral Stepping Exercise 4
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.

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.

Experimental: Increase balance confidence

Other: 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.

Other: Active Control Group Exercise 1
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.

Other: Active Control Group Exercise 2
2. Knee extension Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

Other: Active Control Group Exercise 3
3. Hip flexion Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

Other: Active Control Group Exercise 4
4. Hip abduction Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

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.

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.

Other: Lateral Stepping Exercise 4
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.

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.

Experimental: prove feasible to integrate into an existing community group exercise program

Other: 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.

Other: Active Control Group Exercise 1
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.

Other: Active Control Group Exercise 2
2. Knee extension Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

Other: Active Control Group Exercise 3
3. Hip flexion Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

Other: Active Control Group Exercise 4
4. Hip abduction Three sets of 8-12 repetitions will be performed per limb with the maintenance of end-range contraction of 6 seconds.

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.

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.

Other: Lateral Stepping Exercise 4
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.

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.

Outcome Measures

Primary Outcome Measures

  1. The Mini-BESTest [10-15 minutes]

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

  2. The Functional Gait Assessment [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

  3. The Multidirectional Functional Reach Test [Less than 5 minutes]

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

  4. The Four-Square Step Test [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.

  5. The Activities Balance Confidence Scale [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.

  6. The Parkinson's Disease Questionnaire-39 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. A diagnosis of idiopathic PD stages I, II, or III 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • New York Institute of Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Tautonico, Assistant Professor, New York Institute of Technology
ClinicalTrials.gov Identifier:
NCT05906875
Other Study ID Numbers:
  • BHS- IRB
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 23, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2023