Parkinson Disease
Conditions
Brief 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 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.
Interventions
BEHAVIORALTURN-IT exercise program
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Investigators involved in measuring outcomes and analyzing the data, will remain blinded to the group that participants are assigned to.
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Responsive to levodopa 3. Hoehn & Yahr stages II-IV 4. Age range 55-85 years old 5. self-report of one or more falls in past 12 months 6. 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
1. Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD 2. no medical condition that precludes exercise 3. MoCA ≤ 21 or inability to follow directions 4. excessive use of alcohol or recreational drugs 5. recent change in medication 6. inability to stand and walk for 2 minutes without an assistive device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in variability in number of steps to complete a turn | 6 weeks | Coefficient of variation in the number of steps in a turn, averaged from daily monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in prospective fall rate | 52 weeks | Number of prospective falls recorded for 12 months starting from the end of intervention |
| Change in patient global impression of change | 6 weeks | 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 |
| Change in number of steps to complete a turn | 6 weeks | Number of steps in a turning averaged from daily monitoring |
| Change in turn peak velocity | 6 weeks | Peak velocity of turns averaged from daily monitoring |
| Change in Falls Efficacy Scale International | 6 weeks | A 16 item self-administered questionnaire to assess fear of falling. Score range 16-64 with higher score indicating more fear of falling |
| Change in turn duration | 6 weeks | Time to complete turns averaged from daily monitoring |
| Change in turn trunk jerk | 6 weeks | A measure of smoothness of turning; the rate of change of acceleration during a turn averaged from daily monitoring |
| Change in variability of double-support time | 6 weeks | Coefficient of variation in time of double-support phase |
| Change in lateral trunk range | 6 weeks | range of motion in the trunk during walking, in the lateral direction |
| Change in turn angle amplitude | 6 weeks | Peak size of turn angles averaged from daily monitoring |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in number of turns per hour | 6 weeks | The average number of turns per hour measured during daily monitoring |
| Change in mini-Balance Evaluation Systems Test | 6 weeks | Clinical measure of four balance domains-anticipatory, reactive, sensory, and dynamic gait. Scores range from 0-28 with higher scores indicating worse balance |
| Change in duration of longest walking bout per day | 6 weeks | The longest bout of straight walking per day averaged from daily monitoring |
| Change in number of bouts of walking and steps per day | 6 weeks | The average number of walking bouts and number of steps per day, measured during daily monitoring |
| Change in clinical global impression of change | 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. |
| Change in Parkinson's Disease Questionnaire-39 | 6 weeks | 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 |
| Change in Unified Parkinson's Disease Rating Scale, Part III | 6 weeks | 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 |
| Change in Activities-Specific Balance Confidence Scale | 6 weeks | 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 |
| Change in stride velocity | 6 weeks | Stride velocity during straight walking averaged from daily monitoring |
| Change in stride length | 6 weeks | Stride length during straight walking averaged from daily monitoring |
| Change in cadence | 6 weeks | The number of straight walking steps taken per minute averaged from daily monitoring |
| Change in double support time | 6 weeks | The amount of time both feet were on the ground together during straight walking averaged from daily monitoring |
| Change in angle of foot at heel strike | 6 weeks | The angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring |
| Change in variability of angle of foot at heel strike | 6 weeks | Coefficient of variation of the angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring |
Countries
United States
Outcome results
None listed