Parkinson DiseaseNCT07399613
Effects of Protective Step Training on Proactive and Reactive Motor Adaptations in Parkinson's Disease Patients
A study testing Protective Step Training in people with Parkinson Disease and Fall, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Fall, Protective Step Training
- What is being tested?
- Protective Step Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 18 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- exhibited functionally disabling dyskinesia
- has dystonia, orthostatic hypotension,
- had neurosurgical intervention (deep brain stimulation)
- has and any significant musculoskeletal or metabolic disorders.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glencroft Senior Living: Retirement Community in Arizona
Glendale, Arizona, 85302
About this study
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.
Read the detailed description
Understanding the mechanism of compensation and neuroplasticity to unexpected step perturbation training during walking and static stance can have positive implications on the treatment of PD by helping to design effective training paradigms that remediate fall risk. Current rehabilitation therapies are inadequate at reducing falls in people with Parkinson's disease (PD). While pharmacologic and surgical treatments have proved largely ineffective in treating postural instability and gait dysfunction in people with PD, studies have demonstrated that therapy specifically focusing on posture, gait, and balance may significantly improve these factors and reduce falls. The primary goal of this study was to assess the effectiveness of a novel and promising intervention therapy (protective step training - i.e., PST - balance disturbance/perturbation during treadmill walking) to improve balance as measured by the reaction time and reduce falls in people with PD. A secondary goal was to understand the effects of PST on proactive and reactive feedback responses during stance and gait tasks. Multi-baseline, repeated measures analyses were performed on the multitude of proactive and reactive performance measures to assess the effects of PST on gait and postural stability parameters.
- Conditions
- Parkinson Disease, Fall, Protective Step Training, Falls, Intervention, Fall Prevention Training, Accidental Falls
- Being tested
- Protective Step Training
- Keywords
- Parkinson Disease, Falls, intervention, training, Protective Step Training, accidental falls
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective Step TrainingBehavioural
Also called perturbation training, reactive step training
Perturbation during standing and walking to actively assess proactive as well as reactive motor adaptations.
| Study group | Role | What they receive |
|---|---|---|
| Standing Perturbation Protocol | Experimental | Different postural perturbations were administered - while walking and while standing. Receives: Behavioral: Protective Step Training |
| Walking Perturbation Protocol | Experimental | Different postural perturbations were administered - while walking and while standing. Receives: Behavioral: Protective Step Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint (knee) reaction time
Joint (knee) Reaction time during standing and walking perturbations.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start19 Jan 2022
- Primary completion18 Jan 2023
- Study completion18 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399613
- Sponsor's protocol ID
- STUDY00015237
- Status last verified
- May 2025
- First submitted
- 12 Dec 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37965161
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Protective Step Training on Proactive and Reactive Motor Adaptations in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT07399613
- Acronym / sponsor ID
- STUDY00015237
- Conditions
- Parkinson Disease, Fall, Protective Step Training, Falls, Intervention, Fall Prevention Training, Accidental Falls
- Keywords
- Parkinson Disease, Falls, intervention, training, Protective Step Training, accidental falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Mar 2023 (actual)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Understanding the mechanism of compensation and neuroplasticity to unexpected step perturbation training during walking and static stance can have positive implications on the treatment of PD by helping to design effective training paradigms that remediate fall risk. Current rehabilitation therapies are inadequate at reducing falls in people with Parkinson's disease (PD). While pharmacologic and surgical treatments have proved largely ineffective in treating postural instability and gait dysfunction in people with PD, studies have demonstrated that therapy specifically focusing on posture, gait, and balance may significantly improve these factors and reduce falls. The primary goal of this study was to assess the effectiveness of a novel and promising intervention therapy (protective step training - i.e., PST - balance disturbance/perturbation during treadmill walking) to improve balance as measured by the reaction time and reduce falls in people with PD. A secondary goal was to understand the effects of PST on proactive and reactive feedback responses during stance and gait tasks. Multi-baseline, repeated measures analyses were performed on the multitude of proactive and reactive performance measures to assess the effects of PST on gait and postural stability parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standing Perturbation Protocol | Experimental | Behavioral: Protective Step TrainingDifferent postural perturbations were administered - while walking and while standing. |
| Walking Perturbation Protocol | Experimental | Behavioral: Protective Step TrainingDifferent postural perturbations were administered - while walking and while standing. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- exhibited functionally disabling dyskinesia
- has dystonia, orthostatic hypotension,
- had neurosurgical intervention (deep brain stimulation)
- has and any significant musculoskeletal or metabolic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protective Step TrainingAlso: perturbation training, reactive step trainingPerturbation during standing and walking to actively assess proactive as well as reactive motor adaptations. | Behavioural | Standing Perturbation Protocol, Walking Perturbation Protocol |
Primary outcome
Joint (knee) reaction time
Time frame: one year
Joint (knee) Reaction time during standing and walking perturbations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Results publication: PubMed 37965161Lockhart 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.
- Frontiers Journal ManuscriptLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protective Step Training in people with Parkinson Disease and Fall, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint (knee) reaction time (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07399613, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.