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

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Behavioral: TURN-IT exercise program

• Registration Number: NCT04897256
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-21
• Study Start: 2021-09-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-05-30
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TURN-IT group	TURN-IT exercise program	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 angle amplitude	6 weeks	Peak size of turn angles averaged from daily monitoring
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 turn peak velocity	6 weeks	Peak velocity of turns averaged from daily monitoring
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 lateral trunk range	6 weeks	range of motion in the trunk during walking, in the lateral direction
Change in number of steps to complete a turn	6 weeks	Number of steps in a turning averaged from daily monitoring
Change in variability of double-support time	6 weeks	Coefficient of variation in time of double-support phase

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States