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

T

Tel Aviv Sourasky Medical Center

Status

Unknown

Conditions

Postural Kyphosis
Parkinson's Disease and Parkinsonism

Treatments

Device: ambulatory use of the Upright device

Study type

Interventional

Funder types

Other

Identifiers

NCT03477695
ASMC-17-NG-0728-CTIL

Details and patient eligibility

About

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.

Full 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:

  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.

Enrollment

60 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Upright device
Experimental group
Description:
Ambulatory use of the Upright device
Treatment:
Device: ambulatory use of the Upright device

Trial contacts and locations

1

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Central trial contact

Marina Brozgol; Nir Giladi, MD

Data sourced from clinicaltrials.gov

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