Protective Step Training in Parkinson's Disease

NCT ID: NCT03895814

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2022-06-01

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multi-baseline Step Training

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.

Group Type: EXPERIMENTAL

Protective Step Training

Intervention Type: 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.

Interventions

Protective Step Training

Participants will undergo 6, 1 hour visits (over the course of 2 weeks) where they will be exposed to repeated slips on a treadmill.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Peterson

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

References

Monaghan AS, Hooyman A, Dibble LE, Mehta SH, Peterson DS. Stability Changes in Fall-Prone Individuals With Parkinson Disease Following Reactive Step Training. J Neurol Phys Ther. 2024 Jan 1;48(1):46-53. doi: 10.1097/NPT.0000000000000442. Epub 2023 Jun 1.

Reference Type: DERIVED

PMID: 37259190 (View on PubMed)

Other Identifiers

STUDY00008325

Identifier Type: -

Identifier Source: org_study_id