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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: TURN-IT exercise program

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Graham Harker, MPH; Phone Number: 503-418-2601; Email: harkerg@ohsu.edu
• Study Contact Backup: Name: Jacquie Ellison; Phone Number: 503-329-3828; Email: balance@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Austin Prewitt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TURN-IT group; 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; 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.
No Intervention: No Intervention Control Group; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mini-Balance Evaluation Systems Test	Clinical measure of four balance domains-anticipatory, reactive, sensory, and dynamic gait. Scores range from 0-28 with higher scores indicating worse balance	6 weeks
Change in clinical global impression of change	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.	6 weeks
Change in Parkinson's Disease Questionnaire-39	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	6 weeks
Change in Unified Parkinson's Disease Rating Scale, Part III	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	6 weeks
Change in Activities-Specific Balance Confidence Scale	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	6 weeks
Change in stride velocity	Stride velocity during straight walking averaged from daily monitoring	6 weeks
Change in stride length	Stride length during straight walking averaged from daily monitoring	6 weeks
Change in cadence	The number of straight walking steps taken per minute averaged from daily monitoring	6 weeks
Change in double support time	The amount of time both feet were on the ground together during straight walking averaged from daily monitoring	6 weeks
Change in angle of foot at heel strike	The angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring	6 weeks
Change in variability of angle of foot at heel strike	Coefficient of variation of the angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring	6 weeks
Change in number of turns per hour	The average number of turns per hour measured during daily monitoring	6 weeks
Change in number of bouts of walking and steps per day	The average number of walking bouts and number of steps per day, measured during daily monitoring	6 weeks
Change in duration of longest walking bout per day	The longest bout of straight walking per day averaged from daily monitoring	6 weeks

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Fay Horak, PhD, PT, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: R01HD100383 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon reasonable request, we can share de-identified data related to study outcomes measures.
• IPD Sharing Time Frame: Data would be available 6 months after the end of data collection. Data will be stored in our laboratory data repository and so will be available indefinitely.
• IPD Sharing Access Criteria: Data will not be stored on a public website, however researchers may contact us for access to the data. We will send data electronically via a secure server.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No