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

Study Overview
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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: Complete demographic questionnaires and medical history Walking tests and balance: Short walks at a comfortable speed with or without dual task. Stairs 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. 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.

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

Conditions
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Parkinson's Disease and Parkinsonism, Postural Kyphosis

Intervention / Treatment
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* Device: ambulatory use of the Upright device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upright device<br>Ambulatory use of the Upright device | Device: ambulatory use of the Upright device<br>* Patients will wear the UpRight for a period of two month<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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