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Protective Step Training in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protective Step Training
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Balance, Falls, Posture, Cognition, Training

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Neurologist diagnosed PD
  • Postural Instability / Gait Dysfunction (PIGD)
  • Ability to stand unaided for 5 minutes

Exclusion Criteria:

  • non-PD related neurological pathology
  • orthopedic impairments affecting balance

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multi-baseline Step Training

Arm Description

Participants will be assessed before and after a 2-week baseline period, and again before and after a 2 week "protective step training period. Participants will also be assessed 2 months later at a follow-up visit.

Outcomes

Primary Outcome Measures

Stepping performance, measured as Margin of Stability (MOS)
MOS: Distance between the extrapolated center of mass and base of support at first foot contact after the slip

Secondary Outcome Measures

Stepping performance, measured as First Step Length
Step Length: Length of the first step after the slip
Stepping performance, measured as First Step Latency
Step Latency: Time taken to lift the foot off the ground after the slip start
Cognition, measured as the total score on the "SCales for Outcomes in PArkinson's disease-COGnition" (SCOPA-COG)
SCOPA-COG: This scale characterizes cognitive capacity of several domains, and was developed specifically for people with PD. Range: 0-43 (higher score reflects better cognitive capacity). Subscales/domains are calculated, and the *total* score is calculated as the sum of each subscale.
Structural brain connectivity between the cortex (supplementary motor area), and basal ganglia (striatum)
Diffusion Tensor Imaging data (collected via MRI), will be collected and analyzed to characterize the structural connectivity specifically between the cortex and basal ganglia.

Full Information

First Posted
March 19, 2019
Last Updated
July 18, 2022
Sponsor
Arizona State University
Collaborators
University of Utah, Colorado State University
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1. Study Identification

Unique Protocol Identification Number
NCT03895814
Brief Title
Protective Step Training in Parkinson's Disease
Official Title
Protective Step Training in People With Parkinson's Disease and Postural Disturbances
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
University of Utah, Colorado State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this project is to determine the preliminary effectiveness of protective step training to improve balance and reduce falls in people with Parkinson's disease (PD) and postural disturbances. A secondary purpose is to understand which baseline patient characteristics predict responsiveness to treatment. By informing 1) the effectiveness of a promising rehabilitative intervention, and 2) the selection of the participants that will be most responsive to treatment, these data may enhance clinicians' ability to treat balance disturbances in people with PD. Importantly, protective step training, described in this proposal, can be quickly deployed in the clinic at minimal cost. Therefore, if shown to be effective via this and subsequent trials, this approach can be easily integrated into care, immediately impacting a large number of people with PD.
Detailed Description
This project contains 3 aims: Aims 1 and 2 address the primary goal of this project: Determining the effectiveness of protective step training. Aim 1 will test whether perturbation training can improve protective stepping in people with PD with postural dysfunction. Aim 2 will test whether improvements are retained over 2 months and generalize to untrained perturbation tasks (which may be important for real world situations). Importantly, investigators will also gather exploratory data regarding the effect of perturbation training on falls. Aim 3 addresses the secondary goal of this project: Determining for whom protective step training is most beneficial. Aim 3 will relate behavioral factors and neuroimaging outcomes to the magnitude of improvement in protective stepping. All aims will be tested in people with PD who have postural disturbances. To complete these aims, participants will undergo 12 visits to the laboratory over the course of about 5 months. These will include 6 "training visits" over the course of 2 weeks, surrounded by 6 "assessment" visits before and after the training. During assessment visits, investigators will assess the ability to step quickly in response to a loss of balance (e.g. a slip), as well as thinking assessments and, if eligible, investigators will complete an MRI. During training visits, investigators will train the ability to step quickly in response to a slip. In this study, participants will serve as their own controls. As such, there is no randomization to multiple groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Balance, Falls, Posture, Cognition, Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multi-baseline assessment
Masking
None (Open Label)
Masking Description
The single-group assessment prohibits participant/outcomes masking.
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multi-baseline Step Training
Arm Type
Experimental
Arm Description
Participants will be assessed before and after a 2-week baseline period, and again before and after a 2 week "protective step training period. Participants will also be assessed 2 months later at a follow-up visit.
Intervention Type
Behavioral
Intervention Name(s)
Protective Step Training
Intervention Description
Participants will undergo 6, 1 hour visits (over the course of 2 weeks) where they will be exposed to repeated slips on a treadmill.
Primary Outcome Measure Information:
Title
Stepping performance, measured as Margin of Stability (MOS)
Description
MOS: Distance between the extrapolated center of mass and base of support at first foot contact after the slip
Time Frame
Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)
Secondary Outcome Measure Information:
Title
Stepping performance, measured as First Step Length
Description
Step Length: Length of the first step after the slip
Time Frame
Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)
Title
Stepping performance, measured as First Step Latency
Description
Step Latency: Time taken to lift the foot off the ground after the slip start
Time Frame
Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)
Title
Cognition, measured as the total score on the "SCales for Outcomes in PArkinson's disease-COGnition" (SCOPA-COG)
Description
SCOPA-COG: This scale characterizes cognitive capacity of several domains, and was developed specifically for people with PD. Range: 0-43 (higher score reflects better cognitive capacity). Subscales/domains are calculated, and the *total* score is calculated as the sum of each subscale.
Time Frame
Baseline
Title
Structural brain connectivity between the cortex (supplementary motor area), and basal ganglia (striatum)
Description
Diffusion Tensor Imaging data (collected via MRI), will be collected and analyzed to characterize the structural connectivity specifically between the cortex and basal ganglia.
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Retention of stepping improvement (measured as Margin of Stability; MOS) over 2 months
Description
Characterization of whether MOS changes observed over training period are retained at follow-up.
Time Frame
Change in MOS score from Baseline to Follow-up (10 weeks between collections)
Title
Generalization of stepping improvement (measured as Margin of Stability; MOS)
Description
Characterize whether training impacts MOS of an untrained reactive stepping task
Time Frame
Change in MOS score from Baseline 2 to Post (2 weeks between collections)
Title
Fall frequency
Description
Number of falls will be recorded via fall calendar in the 2 month period prior to training (baseline) and the 2 month period following training (post)
Time Frame
Change in the number of falls during baseline (2 months) and follow-up (2 months) periods.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Neurologist diagnosed PD Postural Instability / Gait Dysfunction (PIGD) Ability to stand unaided for 5 minutes Exclusion Criteria: non-PD related neurological pathology orthopedic impairments affecting balance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Peterson
Organizational Affiliation
Arizona State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared outside of the primary investigator and backup contact, noted above.

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Protective Step Training in Parkinson's Disease

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