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

NCT ID: NCT03477695

Last Updated: 2018-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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:

1. Complete demographic questionnaires and medical history
2. 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.

Conditions

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Parkinson's Disease and Parkinsonism Postural Kyphosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Upright device

Ambulatory use of the Upright device

Group Type EXPERIMENTAL

ambulatory use of the Upright device

Intervention Type DEVICE

Patients will wear the UpRight for a period of two month

Interventions

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ambulatory use of the Upright device

Patients will wear the UpRight for a period of two month

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Parkinson's disease, as defined in the UK Brain Bank criteria
2. Hoehn and Yahr stage I-III
3. Participants who are at stable medication regimen
4. 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nir Giladi, MD

Role: PRINCIPAL_INVESTIGATOR

TASMC

Locations

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Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Marina Brozgol

Role: CONTACT

+97236947513

Nir Giladi, MD

Role: CONTACT

+97236947513

Facility Contacts

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Jefferey Hausdorff

Role: primary

+97236947513

References

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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.

Reference Type BACKGROUND
PMID: 28802759 (View on PubMed)

Other Identifiers

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ASMC-17-NG-0728-CTIL

Identifier Type: -

Identifier Source: org_study_id

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