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

NCT04339543 | Terminated DMC

• 2 other identifiers: 0596-18-EPP20GM109090-06
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Healthy Aging

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 6-month follow-up, 12-months follow-up

• Falls and near falls

  Number and type of falls and near falls experienced, reported in a diary.

  12-months

Secondary Outcomes (1)

• Change in gait biomechanics every 6-months

  Baseline, 6-month follow-up, 12-months follow-up

Study Arms (1)

Longitudinal assessment

OTHER

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.

Other: Cognitive dual-task walking

Interventions

Cognitive dual-task walking OTHER

• 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).

Longitudinal assessment

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Nicholas Stergiou, PhD

  University of Nebraska

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 9, 2020
• Study Start: February 28, 2020
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)