Parkinson DiseaseNCT03895814
Protective Step Training in Parkinson's Disease
A study testing Protective Step Training in people with Parkinson Disease, run by Arizona State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- 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
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 1 Jun 2022
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Neurologist diagnosed PD
- Postural Instability / Gait Dysfunction (PIGD)
- Ability to stand unaided for 5 minutes
Who cannot join
- non-PD related neurological pathology
- orthopedic impairments affecting balance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protective Step Training in People With Parkinson's Disease and Postural Disturbances
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.
Read the 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
- Being tested
- Protective Step Training
- Keywords
- Balance, Falls, Posture, Cognition, Training
- 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
Participants will undergo 6, 1 hour visits (over the course of 2 weeks) where they will be exposed to repeated slips on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Protective Step Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)
Secondary outcomes (4)
Stepping performance, measured as First Step Length
Step Length: Length of the first step after the slip
Measured: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)
Stepping performance, measured as First Step Latency
Step Latency: Time taken to lift the foot off the ground after the slip start
Measured: 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)
SCOPA-COG: This scale characterizes cognitive capacity of several domains, and was developed specifically for people with PD. Range: 0-43 (higher score reflects better cognitive capacity). Subscales/domains are calculated, and the *total* score is calculated as the sum of each subscale.
Measured: Baseline
Structural brain connectivity between the cortex (supplementary motor area), and basal ganglia (striatum)
Diffusion Tensor Imaging data (collected via MRI), will be collected and analyzed to characterize the structural connectivity specifically between the cortex and basal ganglia.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Jun 2019
- Primary completion1 Apr 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-baseline assessment
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, Colorado State University
- Responsible party
- Sponsor
- Investigators
- Daniel Peterson, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895814
- Sponsor's protocol ID
- STUDY00008325
- Status last verified
- Jul 2022
- First submitted
- 19 Mar 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside of the primary investigator and backup contact, noted above.
Publications
Monaghan AS, Hooyman A, Dibble LE, Mehta SH, Peterson DS. Generalization of In-Place Balance Perturbation Training in People With Parkinson Disease. J Neurol Phys Ther. 2024 Jul 1;48(3):165-173. doi: 10.1097/NPT.0000000000000471. Epub 2024 Mar 14.
PubMed 38489661Monaghan 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.
PubMed 37259190
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Step Training in People With Parkinson's Disease and Postural Disturbances
- ClinicalTrials.gov ID
- NCT03895814
- Acronym / sponsor ID
- STUDY00008325
- Conditions
- Parkinson Disease
- Keywords
- Balance, Falls, Posture, Cognition, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- University of Utah, Colorado State University
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 29 Mar 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-baseline assessment
| Arm | Type | Receives |
|---|---|---|
| Multi-baseline Step Training | Experimental | Behavioral: Protective Step TrainingParticipants 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Neurologist diagnosed PD
- Postural Instability / Gait Dysfunction (PIGD)
- Ability to stand unaided for 5 minutes
Key exclusion criteria (2 listed)
- non-PD related neurological pathology
- orthopedic impairments affecting balance
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 TrainingParticipants will undergo 6, 1 hour visits (over the course of 2 weeks) where they will be exposed to repeated slips on a treadmill. | Behavioural | Multi-baseline Step Training |
Primary outcome
Stepping performance, measured as Margin of Stability (MOS)
Time frame: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)
MOS: Distance between the extrapolated center of mass and base of support at first foot contact after the slip
4 secondary outcomes
Stepping performance, measured as First Step Length
Time frame: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)
Stepping performance, measured as First Step Latency
Time frame: 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)
Time frame: Baseline
Structural brain connectivity between the cortex (supplementary motor area), and basal ganglia (striatum)
Time frame: Baseline
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 20 Jul 2022.
- Derived from this study: PubMed 38489661Monaghan AS, Hooyman A, Dibble LE, Mehta SH, Peterson DS. Generalization of In-Place Balance Perturbation Training in People With Parkinson Disease. J Neurol Phys Ther. 2024 Jul 1;48(3):165-173. doi: 10.1097/NPT.0000000000000471. Epub 2024 Mar 14.
- Derived from this study: PubMed 37259190Monaghan 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside of the primary investigator and backup contact, noted above.
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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.
Daniel Peterson principal investigator
Arizona State University
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, 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 3 inclusion and 2 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 20 Jul 2022. 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?
Stepping performance, measured as Margin of Stability (MOS) (time frame: Change across baseline period (2 weeks), compared to change across intervention period (2 weeks)). 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 NCT03895814, which also lists 2 linked publications.
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 20 Jul 2022.