Clinical trial NCT03895814: Protective Step Training in Parkinson's Disease
Official title: Protective Step Training in People With Parkinson's Disease and Postural Disturbances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Balance
Falls
Posture
Cognition
Training
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: University of Utah
name: Colorado State University
First posted: 2019-03-29
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multi-baseline assessment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Stepping performance, measured as Margin of Stability (MOS)
timeFrame: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)
Secondary outcomes:
measure: Stepping performance, measured as First Step Length
timeFrame: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)
measure: Stepping performance, measured as First Step Latency
timeFrame: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)
measure: Cognition, measured as the total score on the "SCales for Outcomes in PArkinson's disease-COGnition" (SCOPA-COG)
timeFrame: Baseline
measure: Structural brain connectivity between the cortex (supplementary motor area), and basal ganglia (striatum)
timeFrame: Baseline
Other outcomes:
measure: Retention of stepping improvement (measured as Margin of Stability; MOS) over 2 months
timeFrame: Change in MOS score from Baseline to Follow-up (10 weeks between collections)
measure: Generalization of stepping improvement (measured as Margin of Stability; MOS)
timeFrame: Change in MOS score from Baseline 2 to Post (2 weeks between collections)
measure: Fall frequency
timeFrame: Change in the number of falls during baseline (2 months) and follow-up (2 months) periods.
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Daniel Peterson
role: PRINCIPAL_INVESTIGATOR
References: