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

Oregon Health & Science University (OHSU)

Status: Active, not recruiting

Conditions: Parkinson Disease

Treatments: Behavioral: TURN-IT exercise program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04897256

R01HD100383 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

TURN-IT group

Experimental group

Description:

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.

Treatment:

Behavioral: TURN-IT exercise program

No Intervention Control Group

No Intervention group

Description:

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.