NCT07399613

Brief Summary

The aim of this study was to investigate to what extent PD affects the ability to walk, respond to balance perturbations (i.e., Protective Step Training) and produce acute short-term effects to improve compensatory reactions and control of unperturbed walking balance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
Last Updated

February 10, 2026

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

December 12, 2024

Last Update Submit

February 3, 2026

Conditions

Keywords

Parkinson Disease, Falls, intervention, training, Protective Step Training, accidental falls

Outcome Measures

Primary Outcomes (1)

  • Joint (knee) reaction time

    Joint (knee) Reaction time during standing and walking perturbations.

    one year

Study Arms (2)

Standing Perturbation Protocol

EXPERIMENTAL

Different postural perturbations were administered - while walking and while standing.

Behavioral: Protective Step Training

Walking Perturbation Protocol

EXPERIMENTAL

Different postural perturbations were administered - while walking and while standing.

Behavioral: Protective Step Training

Interventions

Perturbation during standing and walking to actively assess proactive as well as reactive motor adaptations.

Also known as: perturbation training, reactive step training
Standing Perturbation ProtocolWalking Perturbation Protocol

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • able to ambulate without assistance
  • had no known neurologic, cardiovascular, or orthopedic deficit - (Mini-Mental Status Examination \<25), and had a Hoehn \& Yahr (H\&Y) score between II-III.

You may not qualify if:

  • exhibited functionally disabling dyskinesia
  • has dystonia, orthostatic hypotension,
  • had neurosurgical intervention (deep brain stimulation)
  • has and any significant musculoskeletal or metabolic disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glencroft Senior Living: Retirement Community in Arizona

Glendale, Arizona, 85302, United States

Location

Related Publications (1)

  • Lockhart T, Frames C, Olson M, Moon SH, Peterson D, Lieberman A. Effects of protective step training on proactive and reactive motor adaptations in Parkinson's disease patients. Front Neurol. 2023 Oct 24;14:1211441. doi: 10.3389/fneur.2023.1211441. eCollection 2023.

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Randomized the all walking/training trials
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Crossover design: Prior to testing, subjects were randomly assigned to two groups. One group started with postural perturbation (PP) training (during stance), while the other group began with gait perturbation (GP) training before crossing over (during walking). During this onboarding period, self-reported and observed leg dominance in bilateral mobilizing was utilized to determine the dominant leg that will be perturbed in the walking trials. Investigators described a scenario for the participant in which they were asked which leg they would use to kick a ball over the ground.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2024

First Posted

February 10, 2026

Study Start

January 19, 2022

Primary Completion

January 18, 2023

Study Completion

March 18, 2023

Last Updated

February 10, 2026

Record last verified: 2025-05

Locations