Measurement of Gait Using Opal APDM and Gait Mat in Parkinsonism

NCT02064543 | Completed

• 1 other identifier: STU 072012-090
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The project is a prospective trial comparing Zeno/GAITRite and APDM® in a cohort of persons living with parkinsonian disorders. Ambulatory patients with a parkinsonian syndrome and who are able to provide informed consent will participate in the assessments. Outcome variables include selected gait and balance parameters such as cadence, gait-cycle, stride-length, stride-velocity, turning duration, turning steps, postural sway and anticipatory postural control. These parameters will be measured by the portable inertial sensors developed by APDM® and the Zeno/GaitRite.

Conditions

Parkinsonism

Keywords

Parkinson's disease; gait

Outcome Measures

Primary Outcomes (7)

• gait parameters

  Outcome variables include selected gait and balance such as cadence

  one year

• gait parameters

  Outcome variables include selected gait and balance such as stride-length

  one year

• gait parameters

  Outcome variables include selected gait and balance such as stride-velocity

  one year

• gait parameters

  Outcome variables include selected gait and balance such as turning duration

  one year

• gait parameters

  Outcome variables include selected gait and balance such as turning steps

  one year

• gait parameters

  Outcome variables include selected gait and balance such as postural sway

  one year

• gait parameters

  Outcome variables include selected gait and balance such as anticipatory postural control

  one year

Study Arms (1)

ADPM and GAITRite

mobility assessments (ADPM, GAITRite) measuring gait parameters

Other: GAITRite; Other: ADPM

Interventions

GAITRite OTHER

mobility test assessing gait parameters

ADPM and GAITRite

ADPM OTHER

mobility test assessing gait parameters

ADPM and GAITRite

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults between the ages of 18 and 80 years of age with a primary diagnosis of PD and similar parkinsonian syndromes and clinical signs of FoG

You may qualify if:

• Adults between the ages of 18 and 80 years of age with a primary diagnosis of PD and similar parkinsonian syndromes
• Individuals able to walk 100 feet independently, with or without the use of an assistive device (walker, cane) and follow simple instructions.
• Individuals with sufficient physiological systemic support to participate in the study protocol

You may not qualify if:

• Inability to speak English secondary to the need to understand and follow multistep directions
• A secondary diagnosis (musculoskeletal, cardiopulmonary, neurological) that excludes participation in the study
• Inability to ambulate 100 feet independently with or without an assistive device.
• Inability to follow simple instructions necessary for completion of the testing tasks.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Parkinsonian Disorders; Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Pravin Khemani, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: February 17, 2014
• Study Start: July 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)