Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TURN-IT exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- 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
- Responsive to levodopa
- Hoehn & Yahr stages II-IV
- Age range 55-85 years old
- self-report of one or more falls in past 12 months
- 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:
- Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD
- no medical condition that precludes exercise
- MoCA ≤ 21 or inability to follow directions
- excessive use of alcohol or recreational drugs
- recent change in medication
- inability to stand and walk for 2 minutes without an assistive device
Sites / Locations
- Oregon Health & Science UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TURN-IT group
No Intervention Control Group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Change in prospective fall rate
Number of prospective falls recorded for 12 months starting from the end of intervention
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
Change in number of steps to complete a turn
Number of steps in a turning averaged from daily monitoring
Change in turn peak velocity
Peak velocity of turns averaged from daily monitoring
Change in turn angle amplitude
Peak size of turn angles averaged from daily monitoring
Change in turn duration
Time to complete turns averaged from daily monitoring
Change in turn trunk jerk
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
Coefficient of variation in time of double-support phase
Change in lateral trunk range
range of motion in the trunk during walking, in the lateral direction
Full Information
NCT ID
NCT04897256
First Posted
May 18, 2021
Last Updated
August 23, 2022
Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT04897256
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Investigators involved in measuring outcomes and analyzing the data, will remain blinded to the group that participants are assigned to.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TURN-IT group
Arm Type
Experimental
Arm 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.
Arm Title
No Intervention Control Group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
TURN-IT exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in variability in number of steps to complete a turn
Description
Coefficient of variation in the number of steps in a turn, averaged from daily monitoring
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in Falls Efficacy Scale International
Description
A 16 item self-administered questionnaire to assess fear of falling. Score range 16-64 with higher score indicating more fear of falling
Time Frame
6 weeks
Title
Change in prospective fall rate
Description
Number of prospective falls recorded for 12 months starting from the end of intervention
Time Frame
52 weeks
Title
Change in patient global impression of change
Description
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
Time Frame
6 weeks
Title
Change in number of steps to complete a turn
Description
Number of steps in a turning averaged from daily monitoring
Time Frame
6 weeks
Title
Change in turn peak velocity
Description
Peak velocity of turns averaged from daily monitoring
Time Frame
6 weeks
Title
Change in turn angle amplitude
Description
Peak size of turn angles averaged from daily monitoring
Time Frame
6 weeks
Title
Change in turn duration
Description
Time to complete turns averaged from daily monitoring
Time Frame
6 weeks
Title
Change in turn trunk jerk
Description
A measure of smoothness of turning; the rate of change of acceleration during a turn averaged from daily monitoring
Time Frame
6 weeks
Title
Change in variability of double-support time
Description
Coefficient of variation in time of double-support phase
Time Frame
6 weeks
Title
Change in lateral trunk range
Description
range of motion in the trunk during walking, in the lateral direction
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Change in mini-Balance Evaluation Systems Test
Description
Clinical measure of four balance domains-anticipatory, reactive, sensory, and dynamic gait. Scores range from 0-28 with higher scores indicating worse balance
Time Frame
6 weeks
Title
Change in clinical global impression of change
Description
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.
Time Frame
6 weeks
Title
Change in Parkinson's Disease Questionnaire-39
Description
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
Time Frame
6 weeks
Title
Change in Unified Parkinson's Disease Rating Scale, Part III
Description
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
Time Frame
6 weeks
Title
Change in Activities-Specific Balance Confidence Scale
Description
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
Time Frame
6 weeks
Title
Change in stride velocity
Description
Stride velocity during straight walking averaged from daily monitoring
Time Frame
6 weeks
Title
Change in stride length
Description
Stride length during straight walking averaged from daily monitoring
Time Frame
6 weeks
Title
Change in cadence
Description
The number of straight walking steps taken per minute averaged from daily monitoring
Time Frame
6 weeks
Title
Change in double support time
Description
The amount of time both feet were on the ground together during straight walking averaged from daily monitoring
Time Frame
6 weeks
Title
Change in angle of foot at heel strike
Description
The angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring
Time Frame
6 weeks
Title
Change in variability of angle of foot at heel strike
Description
Coefficient of variation of the angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring
Time Frame
6 weeks
Title
Change in number of turns per hour
Description
The average number of turns per hour measured during daily monitoring
Time Frame
6 weeks
Title
Change in number of bouts of walking and steps per day
Description
The average number of walking bouts and number of steps per day, measured during daily monitoring
Time Frame
6 weeks
Title
Change in duration of longest walking bout per day
Description
The longest bout of straight walking per day averaged from daily monitoring
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Responsive to levodopa
Hoehn & Yahr stages II-IV
Age range 55-85 years old
self-report of one or more falls in past 12 months
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:
Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD
no medical condition that precludes exercise
MoCA ≤ 21 or inability to follow directions
excessive use of alcohol or recreational drugs
recent change in medication
inability to stand and walk for 2 minutes without an assistive device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacquie Gagnon
Phone
503-418-2601
Email
balance@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Graham Harker, MPH
Phone
503-418-2601
Email
harkerg@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fay Horak, PhD, PT
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Austin Prewitt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation
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