Protective Step Training in Parkinson's Disease

NCT03895814 | Completed

• 1 other identifier: STUDY00008325
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Balance; Falls; Posture; Cognition; Training

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (4)

• Stepping performance, measured as First Step Length

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

• Stepping performance, measured as First Step Latency

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

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

  Baseline

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

  Baseline

Other Outcomes (3)

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

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

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

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

• Fall frequency

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

Study Arms (1)

Multi-baseline Step Training

EXPERIMENTAL

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.

Behavioral: Protective Step Training

Interventions

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.

Multi-baseline Step Training

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Arizona State University: lead
• University of Utah: collaborator
• Colorado State University: collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (1)

• 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.

  PMID: 37259190 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Peterson

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The single-group assessment prohibits participant/outcomes masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-baseline assessment

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 29, 2019
• Study Start: June 1, 2019
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)