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Longitudinal Analysis of Gait Variability to Predict Falls in Parkinson's Disease

Primary Purpose

Parkinson Disease, Healthy Aging

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive dual-task walking
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson Disease

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to provide written informed consent
  • 60 years or older
  • Able to walk 10 min uninterrupted without assistance
  • for PD group only: must have a confirmed diagnosis by a trained clinician of idiopathic PD

Exclusion Criteria:

  • other known neurological, orthopedic or cardiothoracic conditions that could interfere with gait and cognitive assessment.
  • surgery affecting gait and balance within 6 months prior to baseline session.

Sites / Locations

  • University of Nebraska at Omaha

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Longitudinal assessment

Arm Description

Participants will take part in a baseline study session, followed by a year of weekly reports of their number of near falls and falls. The same participants will repeat the same study session six months and twelve months after the baseline session.

Outcomes

Primary Outcome Measures

Change in scaling exponent of stride time series every 6-months
Using the detrended fluctuation analysis (DFA). Briefly, DFA estimate the relationship between the size of fluctuations and the size of the 'box' from which these fluctuations are observed. Stride time fluctuations typically scale with the size of the box in a power-law relationship. The slope of this relationship in bi-logarithmic coordinate thus provide the scaling exponent which reflect the degree of scale invariance.
Falls and near falls
Number and type of falls and near falls experienced, reported in a diary.

Secondary Outcome Measures

Change in gait biomechanics every 6-months
Sub-phases of stride cycles, in particular the stance phase (i.e., when the foot is in contact with the ground) and the swing phase (i.e., when the foot is in the air), which will provide information about balance control mechanisms; medial-lateral center of mass movements and local stability, estimated with the Lyapunov exponent, using data from the pelvis sensor, which will provide information about gait stability; coordination between arm and leg movements, which will inform about the degree of rigidity and central synchronization between the arms during walking.

Full Information

First Posted
April 3, 2020
Last Updated
August 24, 2023
Sponsor
University of Nebraska
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04339543
Brief Title
Longitudinal Analysis of Gait Variability to Predict Falls in Parkinson's Disease
Official Title
Longitudinal Assessment of Gait Variability to Predict Falls in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
PI left the institution and the US
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
February 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The broad goal of this research project is to improve the prediction of falls in patients with Parkinson's disease (PD) through a comprehensive multidisciplinary approach that includes longitudinal measurements of walking, cognitive and functional performances. PD is a life-changing disorders affecting one million Americans, with more than 60,000 new cases reported every year. Within 3 years of diagnosis, more than 85% of people with clinically probable PD develop gait problems, which in turn lead to falls resulting in serious injury and reduced quality of life. There is a pressing need to identify fall risk factors before the occurrence of the first fall, and to better understand behavioral and cognitive changes leading to falls in PD patients.
Detailed Description
Participants will take part in a baseline study session, followed by a year of weekly reports of their number of near falls and falls. The same participants will repeat the same study session six months and twelve months after the baseline session. Each of the three study sessions will have a similar design. Each participant will make a visit of approximately 2 hours to the laboratory. At baseline, all participants will complete a medical history questionnaire which will confirm that all inclusion criteria are met. At each measurement interval (i.e., baseline, six-month and twelve-month), participants will be evaluated through a series of examinations and questionnaires prior to data collection. PD patients will be tested at their self-reported peak dose of medication ('on'-state). Upon completion of the tests and questionnaires, participants will be prepared for data collection (footswitches and strap-based IMUs). The effect of dual tasking will be examined through three conditions performed in the following order: single-cognitive testing, which will consist in a phoneme monitoring task (seated in a quiet room with headphones); single-walking, which will consist of simply walking normally (silent headphones); and dual-task walking, which will consist in walking while performing the phoneme monitoring task. The phoneme monitoring task will consist in listening to a text through headphones, and participants will be asked to i) answer ten questions regarding the content of the text after the task, and ii) count how many times two predefined words appeared in the text. During single and dual-task walking, participants will be asked to walk around the track at a speed that they feel would be comfortable while walking through the grocery store or walking to their car, with no instructions regarding the priority to give to each task (walking vs. cognitive task). The texts presented during single-task cognitive testing and dual-task walking will be different. Each trial will last approximately ten minutes, which is required to collect at least 500 stride time intervals for a reliable estimation of the temporal ordering of stride-to-stride fluctuations. Participants will rest between trials for at least five minutes and will be able to rest more if they so desire. Two investigators will always be present during data collection and will walk behind the participant during the walking trials for safety purposes. All participants will be followed for twelve months and will report their falls and near falls experiences. After the baseline session, participants will be provided with a fall diary, in which they will write the date, time, cause, circumstances under which falls or near falls occurred, and the occurrence of any fall-related injury. Participants will be instructed to daily fill the diary and return it every two weeks (with self-addressed stamped return envelope), or to communicate the information via email. In addition, each month participating personnel will call participants to ensure all falls and near falls were reported in case participants fail to fill in the fall diary. Participants will also be called if the investigators do not receive their report a week after the expected date of reception.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Healthy Aging

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Longitudinal assessment
Arm Type
Other
Arm Description
Participants will take part in a baseline study session, followed by a year of weekly reports of their number of near falls and falls. The same participants will repeat the same study session six months and twelve months after the baseline session.
Intervention Type
Other
Intervention Name(s)
Cognitive dual-task walking
Intervention Description
• The task will consist in walking while performing the phoneme monitoring task. The phoneme monitoring task will consist in listening to a text through headphones, and participants will be asked to i) answer ten questions regarding the content of the text after the task, and ii) count how many times two predefined words appeared in the text. During single and dual-task walking, participants will be asked to walk around the track at a speed that they feel would be comfortable while walking through the grocery store or walking to their car, with no instructions regarding the priority to give to each task (walking vs. cognitive task).
Primary Outcome Measure Information:
Title
Change in scaling exponent of stride time series every 6-months
Description
Using the detrended fluctuation analysis (DFA). Briefly, DFA estimate the relationship between the size of fluctuations and the size of the 'box' from which these fluctuations are observed. Stride time fluctuations typically scale with the size of the box in a power-law relationship. The slope of this relationship in bi-logarithmic coordinate thus provide the scaling exponent which reflect the degree of scale invariance.
Time Frame
Baseline, 6-month follow-up, 12-months follow-up
Title
Falls and near falls
Description
Number and type of falls and near falls experienced, reported in a diary.
Time Frame
12-months
Secondary Outcome Measure Information:
Title
Change in gait biomechanics every 6-months
Description
Sub-phases of stride cycles, in particular the stance phase (i.e., when the foot is in contact with the ground) and the swing phase (i.e., when the foot is in the air), which will provide information about balance control mechanisms; medial-lateral center of mass movements and local stability, estimated with the Lyapunov exponent, using data from the pelvis sensor, which will provide information about gait stability; coordination between arm and leg movements, which will inform about the degree of rigidity and central synchronization between the arms during walking.
Time Frame
Baseline, 6-month follow-up, 12-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Able to provide written informed consent 60 years or older Able to walk 10 min uninterrupted without assistance for PD group only: must have a confirmed diagnosis by a trained clinician of idiopathic PD Exclusion Criteria: other known neurological, orthopedic or cardiothoracic conditions that could interfere with gait and cognitive assessment. surgery affecting gait and balance within 6 months prior to baseline session.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Stergiou, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Study Director
Facility Information:
Facility Name
University of Nebraska at Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68182
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Longitudinal Analysis of Gait Variability to Predict Falls in Parkinson's Disease

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