Protective Step Training in Parkinson's Disease

Arizona State University (ASU)

Status: Completed

Conditions: Parkinson Disease

Treatments: Behavioral: Protective Step Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03895814

STUDY00008325

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Multi-baseline Step Training

Experimental group

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.

Treatment:

Behavioral: Protective Step Training