Clinical trial NCT04897256: Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation
Official title: Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in variability in number of steps to complete a turn
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Falls Efficacy Scale International
timeFrame: 6 weeks
measure: Change in prospective fall rate
timeFrame: 52 weeks
measure: Change in patient global impression of change
timeFrame: 6 weeks
measure: Change in number of steps to complete a turn
timeFrame: 6 weeks
measure: Change in turn peak velocity
timeFrame: 6 weeks
measure: Change in turn angle amplitude
timeFrame: 6 weeks
measure: Change in turn duration
timeFrame: 6 weeks
measure: Change in turn trunk jerk
timeFrame: 6 weeks
measure: Change in variability of double-support time
timeFrame: 6 weeks
measure: Change in lateral trunk range
timeFrame: 6 weeks
Other outcomes:
measure: Change in mini-Balance Evaluation Systems Test
timeFrame: 6 weeks
measure: Change in clinical global impression of change
timeFrame: 6 weeks
measure: Change in Parkinson's Disease Questionnaire-39
timeFrame: 6 weeks
measure: Change in Unified Parkinson's Disease Rating Scale, Part III
timeFrame: 6 weeks
measure: Change in Activities-Specific Balance Confidence Scale
timeFrame: 6 weeks
measure: Change in stride velocity
timeFrame: 6 weeks
measure: Change in stride length
timeFrame: 6 weeks
measure: Change in cadence
timeFrame: 6 weeks
measure: Change in double support time
timeFrame: 6 weeks
measure: Change in angle of foot at heel strike
timeFrame: 6 weeks
measure: Change in variability of angle of foot at heel strike
timeFrame: 6 weeks
measure: Change in number of turns per hour
timeFrame: 6 weeks
measure: Change in number of bouts of walking and steps per day
timeFrame: 6 weeks
measure: Change in duration of longest walking bout per day
timeFrame: 6 weeks
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Fay Horak, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: