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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD100383 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TURN-IT exercise program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in variability in number of steps to complete a turn | Coefficient of variation in the number of steps in a turn, averaged from daily monitoring | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Falls Efficacy Scale International | A 16 item self-administered questionnaire to assess fear of falling. Score range 16-64 with higher score indicating more fear of falling | 6 weeks |
| Change in prospective fall rate |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mini-Balance Evaluation Systems Test | Clinical measure of four balance domains-anticipatory, reactive, sensory, and dynamic gait. Scores range from 0-28 with higher scores indicating worse balance | 6 weeks |
| Change in clinical global impression of change |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fay Horak, PhD, PT | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36443737 | Derived | 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. |
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Upon reasonable request, we can share de-identified data related to study outcomes measures.
Data would be available 6 months after the end of data collection. Data will be stored in our laboratory data repository and so will be available indefinitely.
Data will not be stored on a public website, however researchers may contact us for access to the data. We will send data electronically via a secure server.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Investigators involved in measuring outcomes and analyzing the data, will remain blinded to the group that participants are assigned to.
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Number of prospective falls recorded for 12 months starting from the end of intervention
| 52 weeks |
| Change in 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 | 6 weeks |
| Change in number of steps to complete a turn | Number of steps in a turning averaged from daily monitoring | 6 weeks |
| Change in turn peak velocity | Peak velocity of turns averaged from daily monitoring | 6 weeks |
| Change in turn angle amplitude | Peak size of turn angles averaged from daily monitoring | 6 weeks |
| Change in turn duration | Time to complete turns averaged from daily monitoring | 6 weeks |
| Change in turn trunk jerk | A measure of smoothness of turning; the rate of change of acceleration during a turn averaged from daily monitoring | 6 weeks |
| Change in variability of double-support time | Coefficient of variation in time of double-support phase | 6 weeks |
| Change in lateral trunk range | range of motion in the trunk during walking, in the lateral direction | 6 weeks |
Question of clinician's rating of participant mobility. Score range from 1-7 with 1-3 indicating improvement, 4 no change, and 5-7 worsening of mobility. |
| 6 weeks |
| Change in Parkinson's Disease Questionnaire-39 | A 39 item self-report questionnaire to assess Parkinson's disease specific health related quality in eight domains of quality of life. Each item scores from 0 (never) to 4 (always). Sub-scale scores and a Parkinson's Disease summary index (PDSI; sum of eight subsections/8) representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life | 6 weeks |
| Change in Unified Parkinson's Disease Rating Scale, Part III | A clinical scale to assess severity of motor symptoms in Parkinson's disease. Each item is scored 0 (normal) to 4 (severe) with a score range from 0-132 | 6 weeks |
| Change in Activities-Specific Balance Confidence Scale | A 16-item self-report scale that participants rate their confidence in performing daily activities. Score range from 0-100% with 0% meaning no confidence and 100% completely confident | 6 weeks |
| Change in stride velocity | Stride velocity during straight walking averaged from daily monitoring | 6 weeks |
| Change in stride length | Stride length during straight walking averaged from daily monitoring | 6 weeks |
| Change in cadence | The number of straight walking steps taken per minute averaged from daily monitoring | 6 weeks |
| Change in double support time | The amount of time both feet were on the ground together during straight walking averaged from daily monitoring | 6 weeks |
| Change in angle of foot at heel strike | The angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring | 6 weeks |
| Change in variability of angle of foot at heel strike | Coefficient of variation of the angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring | 6 weeks |
| Change in number of turns per hour | The average number of turns per hour measured during daily monitoring | 6 weeks |
| Change in number of bouts of walking and steps per day | The average number of walking bouts and number of steps per day, measured during daily monitoring | 6 weeks |
| Change in duration of longest walking bout per day | The longest bout of straight walking per day averaged from daily monitoring | 6 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |