Measurement of Gait Using Opal APDM and Gait Mat in Parki... | NCT02064543

Studies
Measurement of Gait Using Opal APDM and Gait Mat in Parkinsonism

NCT02064543

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

Sep 18, 2019Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Parkinsonism

Interventions

GAITRite
ADPM

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Jan 22, 2014

First Submission Date that Met QC Criteria

Feb 14, 2014

First Posted Date

Feb 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2019

Last Update Posted Date

Sep 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Testing

Participants after screening and consenting will:

Have their height measured and fit with the APDM Opals (each device is a two inch square attached by velcro), one device is attached to each leg, each arm, and the trunk and chest and receive an introduction to walking on the gait mat.
Participants are then asked to walk at a self selected walking speed down the gait mat. The participants will complete multiple passes (8-10 passes, total 75-100 feet) across the gait mat while wearing the APDM units to concurrently collect all temporal and spatial data needed to answer the research question. The Zeno mat is the intended primary gait mat for this study. The GaitRite will only be utilized in the case of a technical issue with the Zeno in order to insure completion of the data collection.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADPM and GAITRite		mobility assessments (ADPM, GAITRite) measuring gait parameters	Other: GAITRite Other: ADPM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GAITRite	Other	mobility test assessing gait parameters	ADPM and GAITRite

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pravin Khemani, M.D.	University of Texas Southwestern Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UT Southwestern Medical Center		Dallas	Texas	75390	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020734	Parkinsonian Disorders
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided