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

Parkinson's Disease and Parkinsonism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03477695
• Other study ID #: ASMC-17-NG-0728-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2018
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Marina Brozgol
• Phone: +97236947513
• Email: marina.brozgol[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Kyphosis
• Parkinson Disease
• Parkinson's Disease and Parkinsonism
• Parkinsonian Disorders
• Postural Kyphosis

Intervention

Device:
• ambulatory use of the Upright device
Patients will wear the UpRight for a period of two month

Locations

Country	Name	City	State
Israel	Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average trunk angle in the sagittal plane using a Postural Analysis Chart	Postural Analysis	8 weeks
Secondary	Patient satisfaction by VAS scores	Results for the VAS scores with possible range 0 (worst) to 10 (best)	8 weeks