Parkinson DiseaseNCT06815302
TURN-IT FOG: Improving Turning and Freezing of Gait in People With PD
A study testing Experimental intervention and Active intervention in people with Parkinson Disease and Freezing of Gait Symptoms in Parkinson Disease, run by Oregon Health and Science University at 3 sites in 2 countries.
Trial summary
The goals of this clinical trial are to 1) learn how two different rehabilitation interventions for PD can reduce Freezing of Gait (FOG) in people with Parkinson's disease, as assessed by patients, clinicians, and wearable sensors, and 2) to explore whether two different rehabilitation intervention can reduce FOG and… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease, Freezing of Gait Symptoms in Parkinson Disease
- What is being tested?
- Experimental intervention and Active intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with one or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
- reporting FOG in the New Freezing of Gait questionnaire (N-FOGQ)
- Hoehn \& Yahr stages II-IV
- ages 50-80 years old
- cognitive ability sufficient to participate in testing procedures and exercise classes
- be willing and able to participate in exercise intervention 3x/week for 6 weeks
Who cannot join
- Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and turning (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease)
- medical condition or medications that precludes moderate-intensity exercise
- Montreal Cognitive Assessment (MoCA) ≤21 or inability to follow directions
- excessive use of alcohol or recreational drugs
- recent change in medication
- inability to stand and walk for 2 minutes without an assistive device
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
- Recruiting
Arizona State University
Tempe, Arizona, 85281
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo, Bauru Campus
Bauru, São Paulo, 17012-230
About this study
Official title: TURN-IT FOG: A Novel Intervention to Improve Turning in People With PD and Freezing of Gait
The goals of this clinical trial are to 1) learn how two different rehabilitation interventions for PD can reduce Freezing of Gait (FOG) in people with Parkinson's disease, as assessed by patients, clinicians, and wearable sensors, and 2) to explore whether two different rehabilitation intervention can reduce FOG and improve daily life mobility in people with FOG sufficiently to justify a clinical trial.
Participants will:
- Be randomly assigned to one of two intervention groups (turning-focused agility exercise or strength-based exercise)
- Have one-on-one training sessions three times per week for 6 weeks
- Perform in-lab assessments before beginning and after completing the study intervention
- Use wearable mobility sensors during daily life to measure their walking and balance
- Being tested
- Experimental intervention, Active intervention
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental interventionBehavioural
Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.
Active interventionBehavioural
Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic balance exercise intervention group | Experimental | Six weeks of exercise intervention to improve gait disturbances.
Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding. Receives: Behavioral: Experimental intervention |
| Strength training exercise intervention group | Active comparator | Six weeks of exercise intervention to improve gait disturbances.
Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding. Receives: Behavioral: Active intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient- Perceived Freezing of Gait Severity
Change in freezing of gait severity with the intervention (scored in likert scale by the patient; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse)
Measured: From enrollment/randomization through intervention; 8 weeks
Clinician- Perceived Freezing of Gait Severity
Change in freezing of gait severity with the intervention (scored in likert scale by the clinician; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse
Measured: From enrollment/randomization through intervention; 8 weeks
Sensors-based Freezing of gait severity
Freezing of Gait Index calculated during a 360 degrees turning in place from wearable sensors; continuous scale, with a higher positive score meaning a greater level of freezing of gait.
Measured: From enrollment/randomization through intervention; 8 weeks
Secondary outcomes (1)
Time Spent in FOG during daily life
% time spent FOG compared to walking during daily life calculated from wearable sensors
Measured: From enrollment/randomization through intervention; 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start2 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Martina Mancini, Oregon Health and Science University
- Investigators
- Martina Mancini, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815302
- Sponsor's protocol ID
- MJFF-024692
- Other IDs
- MJFF-024692
- Status last verified
- Jul 2025
- First submitted
- 3 Feb 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data related to study outcomes measures will be publicly shared
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TURN-IT FOG: A Novel Intervention to Improve Turning in People With PD and Freezing of Gait
- ClinicalTrials.gov ID
- NCT06815302
- Acronym / sponsor ID
- MJFF-024692
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Feb 2025 (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 goals of this clinical trial are to 1) learn how two different rehabilitation interventions for PD can reduce Freezing of Gait (FOG) in people with Parkinson's disease, as assessed by patients, clinicians, and wearable sensors, and 2) to explore whether two different rehabilitation intervention can reduce FOG and improve daily life mobility in people with FOG sufficiently to justify a clinical trial.
Participants will:
- Be randomly assigned to one of two intervention groups (turning-focused agility exercise or strength-based exercise)
- Have one-on-one training sessions three times per week for 6 weeks
- Perform in-lab assessments before beginning and after completing the study intervention
- Use wearable mobility sensors during daily life to measure their walking and balance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic balance exercise intervention group | Experimental | Behavioral: Experimental interventionSix weeks of exercise intervention to improve gait disturbances. Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding. |
| Strength training exercise intervention group | Active comparator | Behavioral: Active interventionSix weeks of exercise intervention to improve gait disturbances. Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with one or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
- reporting FOG in the New Freezing of Gait questionnaire (N-FOGQ)
- Hoehn \& Yahr stages II-IV
- ages 50-80 years old
- cognitive ability sufficient to participate in testing procedures and exercise classes
Key exclusion criteria (6 listed)
- Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and turning (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease)
- medical condition or medications that precludes moderate-intensity exercise
- Montreal Cognitive Assessment (MoCA) ≤21 or inability to follow directions
- excessive use of alcohol or recreational drugs
- recent change in medication
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 |
|---|---|---|
| Experimental interventionSpecific participant procedures in experimental and active control interventions are simplified to preserve study blinding. | Behavioural | Dynamic balance exercise intervention group |
| Active interventionSpecific participant procedures in experimental and active control interventions are simplified to preserve study blinding. | Behavioural | Strength training exercise intervention group |
Primary outcome
Patient- Perceived Freezing of Gait Severity
Time frame: From enrollment/randomization through intervention; 8 weeks
Change in freezing of gait severity with the intervention (scored in likert scale by the patient; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse)
Clinician- Perceived Freezing of Gait Severity
Time frame: From enrollment/randomization through intervention; 8 weeks
Change in freezing of gait severity with the intervention (scored in likert scale by the clinician; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse
Sensors-based Freezing of gait severity
Time frame: From enrollment/randomization through intervention; 8 weeks
Freezing of Gait Index calculated during a 360 degrees turning in place from wearable sensors; continuous scale, with a higher positive score meaning a greater level of freezing of gait.
1 secondary outcome
Time Spent in FOG during daily life
Time frame: From enrollment/randomization through intervention; 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified data related to study outcomes measures will be publicly shared
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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.
Martina Mancini, PhD principal investigator
Oregon Health and Science University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental intervention and Active intervention in people with Parkinson Disease and Freezing of Gait Symptoms in Parkinson Disease, run by Oregon Health and Science University at 3 sites in 2 countries.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Graham R Harker, MPH ((503) 418-2601, harkerg@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient- Perceived Freezing of Gait Severity (time frame: From enrollment/randomization through intervention; 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2025.