Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: TURN-IT exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 OHSU campus, and also refrain from changes in anti-parkinson medications and exercise levels. Exclusion Criteria: Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD no medical condition that precludes exercise 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TURN-IT group<br>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. | Behavioral: TURN-IT exercise program<br>* 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.<br>|
| No Intervention: No Intervention Control Group<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |