Parkinson DiseaseNCT04897256
Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation
A study testing TURN-IT exercise program in people with Parkinson Disease, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The goal of this intervention is to explore the effectiveness of a Turning Intervention (TURN-IT) to improve quality of turning in participants with Parkinson's Disease (PD). An unique exercise program has been developed - TURN-IT - in which participants practice exercises that focus on physiological constraints that… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- TURN-IT exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2021to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 85 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 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
- Responsive to levodopa
- Hoehn \& Yahr stages II-IV
- Age range 55-85 years old
- self-report of one or more falls in past 12 months
- willing and able to attend exercise intervention sessions at Oregon Health \& Science University (OHSU) campus, and also refrain from changes in anti-parkinson medications and exercise levels.
Who cannot join
- Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD
- no medical condition that precludes 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
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The goal of this intervention is to explore the effectiveness of a Turning Intervention (TURN-IT) to improve quality of turning in participants with Parkinson's Disease (PD). An unique exercise program has been developed - TURN-IT - in which participants practice exercises that focus on physiological constraints that impair turning ability, such as axial rigidity, narrow base of support, bradykinesia, and inflexible set-shifting. The 60 participants with PD and a history of falls in the previous 12 months, will be randomized into a 6-week, 3x/week, one-on-one TURN-IT group or No-Intervention Control group. This pilot intervention study will determine the number of subjects needed for a future clinical trial and will determine the sensitivity to change with rehabilitation our daily-life turning quality measures (such as, mean and variability of number of steps to turn, turn amplitude, turn velocity). The investigators predict that the TURN-IT program will improve turning in daily life enough to justify a larger clinical trial.
- Conditions
- Parkinson Disease
- Being tested
- TURN-IT exercise program
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURN-IT exercise programBehavioural
Based on the exercise motor learning principles, participants spend 10-15 minutes at each Exercise Station that focuses on particular constraints of turning ability. The stations will focus on important underlying aspects of turning, such as weight-shifting and increasing axial rotation during functional turning tasks. Each station will be progressed across levels to make more challenging (such as adding a dual task). Initially participants will be supported in an overhead body-weight support system (ZeroG) to allow them to practice challenging exercises without the risk of falling.
| Study group | Role | What they receive |
|---|---|---|
| TURN-IT group | Experimental | Participants in the treatment group will attend supervised, 1-hour classes, 3 times per week for 6 weeks, one-on-one with the same exercise trainer, overseen by a physical therapist investigator. Receives: Behavioral: TURN-IT exercise program |
| No Intervention Control Group | No intervention | Participants in this group will be tested at baseline and 6 weeks later. They will go about their normal daily life during the 6 week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability in Number of Steps to Complete a Turn
The coefficient of variation in the number of steps in a turn, averaged from daily monitoring, as measured at 6 weeks.
Measured: 6 weeks
Secondary outcomes (9)
Change in Falls Efficacy Scale International
The difference in the Falls Efficacy Scale, as measured at baseline and 6 weeks. The Falls Efficacy Scale is a 16 item self-administered questionnaire to assess fear of falling. Scores range 16-64 with higher score indicating more fear of falling.
Measured: baseline and 6 weeks
Prospective Fall Incidence
Number of prospective falls recorded for 12 months starting from the end of intervention
Measured: 52 weeks
Patient Global Impression of Change
Question of participant's rating of mobility. Score range from 1-7 with 1-3 indicating improvement, 4 no change, and 5-7 worsening of mobility. Single score provided at the end of 6 week period.
Measured: 6 weeks
Number of Steps to Complete a Turn
The number of steps in a turning averaged from daily monitoring, as measured at 6 weeks.
Measured: 6 weeks
Turn Peak Velocity
Peak velocity of turns averaged from daily monitoring, as measured at 6 weeks.
Measured: 6 weeks
Turn Angle Amplitude
The peak size of turn angles averaged from daily monitoring, as measured at 6 weeks.
Measured: 6 weeks
Turn Duration
Time to complete turns averaged from daily monitoring, as measured at 6 weeks.
Measured: 6 weeks
Variability of Double-support Time
The coefficient of variation in time of double-support phase, as measured at 6 weeks.
Measured: 6 weeks
Lateral Trunk Range
The range of motion in the trunk during walking, in the lateral direction, as measured at 6 weeks.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start13 Sep 2021
- Primary completion30 Jun 2025
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Martina Mancini, Oregon Health and Science University
- Investigators
- Fay Horak, PhD, PT, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897256
- Sponsor's protocol ID
- R01HD100383
- Other IDs
- R01HD100383
- Status last verified
- Nov 2026
- First submitted
- 18 May 2021
- Last updated
- 6 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request, we can share de-identified data related to study outcomes measures.
Publications
King LA, Carlson-Kuhta P, Wilhelm JL, Lapidus JA, Dale ML, Talman LS, Barlow N, Mancini M, Horak FB. TURN-IT: a novel turning intervention program to improve quality of turning in daily life in people with Parkinson's disease. BMC Neurol. 2022 Nov 28;22(1):442. doi: 10.1186/s12883-022-02934-5.
PubMed 36443737
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation
- ClinicalTrials.gov ID
- NCT04897256
- Acronym / sponsor ID
- R01HD100383
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Posted 6 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this intervention is to explore the effectiveness of a Turning Intervention (TURN-IT) to improve quality of turning in participants with Parkinson's Disease (PD). An unique exercise program has been developed - TURN-IT - in which participants practice exercises that focus on physiological constraints that impair turning ability, such as axial rigidity, narrow base of support, bradykinesia, and inflexible set-shifting. The 60 participants with PD and a history of falls in the previous 12 months, will be randomized into a 6-week, 3x/week, one-on-one TURN-IT group or No-Intervention Control group. This pilot intervention study will determine the number of subjects needed for a future clinical trial and will determine the sensitivity to change with rehabilitation our daily-life turning quality measures (such as, mean and variability of number of steps to turn, turn amplitude, turn velocity). The investigators predict that the TURN-IT program will improve turning in daily life enough to justify a larger clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TURN-IT group | Experimental | Behavioral: TURN-IT exercise programParticipants in the treatment group will attend supervised, 1-hour classes, 3 times per week for 6 weeks, one-on-one with the same exercise trainer, overseen by a physical therapist investigator. |
| No Intervention Control Group | No intervention | –Participants in this group will be tested at baseline and 6 weeks later. They will go about their normal daily life during the 6 week period. |
Who may qualify
- Ages
- 55 to 85 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 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
- Responsive to levodopa
- Hoehn \& Yahr stages II-IV
- Age range 55-85 years old
- self-report of one or more falls in past 12 months
Key exclusion criteria (6 listed)
- Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD
- no medical condition that precludes 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 |
|---|---|---|
| TURN-IT exercise programBased on the exercise motor learning principles, participants spend 10-15 minutes at each Exercise Station that focuses on particular constraints of turning ability. The stations will focus on important underlying aspects of turning, such as weight-shifting and increasing axial rotation during functional turning tasks. Each station will be progressed across levels to make more challenging (such as adding a dual task). Initially participants will be supported in an overhead body-weight support system (ZeroG) to allow them to practice challenging exercises without the risk of falling. | Behavioural | TURN-IT group |
Primary outcome
Variability in Number of Steps to Complete a Turn
Time frame: 6 weeks
The coefficient of variation in the number of steps in a turn, averaged from daily monitoring, as measured at 6 weeks.
9 secondary outcomes
Change in Falls Efficacy Scale International
Time frame: baseline and 6 weeks
Prospective Fall Incidence
Time frame: 52 weeks
Patient Global Impression of Change
Time frame: 6 weeks
Number of Steps to Complete a Turn
Time frame: 6 weeks
Turn Peak Velocity
Time frame: 6 weeks
Turn Angle Amplitude
Time frame: 6 weeks
Turn Duration
Time frame: 6 weeks
Variability of Double-support Time
Time frame: 6 weeks
Lateral Trunk Range
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36443737King LA, Carlson-Kuhta P, Wilhelm JL, Lapidus JA, Dale ML, Talman LS, Barlow N, Mancini M, Horak FB. TURN-IT: a novel turning intervention program to improve quality of turning in daily life in people with Parkinson's disease. BMC Neurol. 2022 Nov 28;22(1):442. doi: 10.1186/s12883-022-02934-5.
- Individual participant dataSharing planned: Yes. Upon reasonable request, we can share de-identified data related to study outcomes measures.
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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.
Fay Horak, PhD, PT principal investigator
Oregon Health and Science 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 TURN-IT exercise program in people with Parkinson Disease, run by Oregon Health and Science 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 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: finished, as of the sponsor's last update on 6 Nov 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?
Yes. Results are posted in the registry (first posted 6 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Variability in Number of Steps to Complete a Turn (time frame: 6 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 NCT04897256, 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 6 Nov 2026.