Improving Posture in Parkinson's Patients Through Home-ba... | NCT03477695

Studies
Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback

NCT03477695

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

May 8, 2018Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Parkinson's Disease and Parkinsonism
Postural Kyphosis

Interventions

ambulatory use of the Upright device

Countries

Israel

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Mar 20, 2018

First Submission Date that Met QC Criteria

Mar 20, 2018

First Posted Date

Mar 26, 2018Actual

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

May 6, 2018

Last Update Posted Date

May 8, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

A stooped posture is one of the characteristic motor symptoms of patients with Parkinson's disease, and has been linked to impairments in ADL and QOL. We aimed to test the efficacy, safety, practical utility and user-friendliness of a posture correction and vibrotactile trunk angle feedback device (the UpRight) in the home setting of patients with Parkinson's disease with a stooped posture.

Detailed Description

The subjects will be asked to arrive at the Gait laboratory for Mobility Research at Tel Aviv Medical Center. After a detailed explanation of the research procedure and after signing the consent form, they will be introduced to the UPRIGHT GO device. Participances will practice operating and placing the device on the body.

With the device attached to upper back, a number of short clinical tests will be performed:

Complete demographic questionnaires and medical history
Walking tests and balance:
1. Short walks at a comfortable speed with or without dual task.
2. Stairs
3. Performing daily tasks, such as entering and exiting a room, negotiating obstacles (shoebox), walking between obstacles, buttons, tying laces, carrying small objects on a tray, bringing a glass of water etc.
4. Timed "Get up and go test" All tests are supervised by a physiotherapist .

Upon completion of the tests, the UPRIGHT device will be delivered for use and exercise for 2 months. Physiotherapist will guide to maintain the devices (such as charging devices and connecting to power).

At the end of the training period, the participans will be invited again to Gait Lab for post tests.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Upright device	Experimental	Ambulatory use of the Upright device	Device: ambulatory use of the Upright device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ambulatory use of the Upright device	Device	Patients will wear the UpRight for a period of two month	Upright device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average trunk angle in the sagittal plane using a Postural Analysis Chart	Postural Analysis	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction by VAS scores	Results for the VAS scores with possible range 0 (worst) to 10 (best)	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Diagnosis of Parkinson's disease, as defined in the UK Brain Bank criteria
Hoehn and Yahr stage I-III
Participants who are at stable medication regimen
Able to walk independently for at least 5 minutes with or without support of accessory device.

Exclusion criteria:

1. Mini Mental State Exam (MMSE) score< 24

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marina Brozgol	Contact	+97236947513		marina.brozgol@gmail.com
Nir Giladi, MD	Contact	+97236947513		nirg@tlvmc.gov.il

Overall Officials

Name	Affiliation	Role
Nir Giladi, MD	TASMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center	Recruiting	Tel Aviv		64239	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28802759	Background	van Wegen EEH, de Goede CJT, Kwakkel G, van Kordelaar J. Sensor assisted self-management in Parkinson's disease: A feasibility study of ambulatory posture detection and feedback to treat stooped posture. Parkinsonism Relat Disord. 2018 Jan;46 Suppl 1:S57-S61. doi: 10.1016/j.parkreldis.2017.07.024. Epub 2017 Jul 25.

ID	Term
D010300	Parkinson Disease
D020734	Parkinsonian Disorders

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