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Completed

NCT Number: NCT03895814

Protective Step Training in Parkinson's Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protective step training

Behavioral

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 outcomes

  1. Stepping performance, measured as Margin of Stability (MOS)

    Time frame: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)

    MOS: Distance between the extrapolated center of mass and base of support at first foot contact after the slip

Secondary outcomes

  1. Stepping performance, measured as First Step Length

    Time frame: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)

    Step Length: Length of the first step after the slip

  2. Stepping performance, measured as First Step Latency

    Time frame: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)

    Step Latency: Time taken to lift the foot off the ground after the slip start

  3. Cognition, measured as the total score on the "SCales for Outcomes in PArkinson's disease-COGnition" (SCOPA-COG)

    Time frame: Baseline

    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.

  4. Structural brain connectivity between the cortex (supplementary motor area), and basal ganglia (striatum)

    Time frame: Baseline

    Diffusion Tensor Imaging data (collected via MRI), will be collected and analyzed to characterize the structural connectivity specifically between the cortex and basal ganglia.

Other outcomes

  1. Retention of stepping improvement (measured as Margin of Stability; MOS) over 2 months

    Time frame: Change in MOS score from Baseline to Follow-up (10 weeks between collections)

    Characterization of whether MOS changes observed over training period are retained at follow-up.

  2. Generalization of stepping improvement (measured as Margin of Stability; MOS)

    Time frame: Change in MOS score from Baseline 2 to Post (2 weeks between collections)

    Characterize whether training impacts MOS of an untrained reactive stepping task

  3. Fall frequency

    Time frame: Change in the number of falls during baseline (2 months) and follow-up (2 months) periods.

    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)

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Colorado State University
  • University of Utah

Registry information

Official study title

Protective Step Training in People With Parkinson's Disease and Postural Disturbances

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2019
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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