A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
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|ClinicalTrials.gov Identifier: NCT04117737|
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : December 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Gait Disorders, Neurologic||Other: Virtual reality combined with anti-gravity treadmill||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Outcomes assessor was blinded to outcomes values between sessions and to the adherence of participants to the intervention.|
|Official Title:||Effects of Virtual Reality Combined With Antigravity Treadmill Rehabilitation for Gait Improvement of Patients With Parkinson's Disease: a Pilot Study|
|Actual Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Other: Virtual reality combined with anti-gravity treadmill
The system is composed of three major parts: the treadmill, the antigravity system and the virtual reality system.
The treadmill is the base of the device. It is a rounded and concave structure that permits to walk in all direction. For simulate anti-gravity, a harness and pulley system allow to regulate the weight. Finally, the virtual reality system enables participants to simulate an experience of daily life.
- Changes in gait autonomy [ Time Frame: Baseline and 4-weeks ]Changes in gait autonomy will be measured by 6-Minutes Walking Test (6MWT). The 6MWT consists of measuring the maximum distance (in meters) that the subject can walk during 6 minutes in a flat surface.
- Changes in gait speed [ Time Frame: Baseline and 4-weeks ]Changes in gait speed will be measured by 10-Meter Walk Test (10MWT). The 10MWT consists of asking the subject to walk a 14m distance on flat area and measure the time spent from meter 2 to meter 12. Time will be measured by a digital chronometer. Gait speed will be calculated in meter per second.
- Changes in balance and gait ability [ Time Frame: Baseline and 4-weeks ]Changes in balance and gait ability will be measured by Tinetti scale. The Tinetti test is a simple, reproducible way of assessing the risk of falling in the elderly. This scale is composed of two value, static and dynamic: the test grants a maximum of 16 points for static part (sitting) and 12 point for dynamic (walking) part. Higher is the score, better is the performance.
- Changes in quality of life [ Time Frame: Baseline and 4-weeks ]Changes in quality of life will be measured by by 36-Item Short-Form Health Survey (SF-36). SF-36 assesses 8 physical and mental health domains: 1) Physical Functioning, 2) Social Functioning, 3) Role-Physical, 4) Bodily Pain, 5) Mental Health), 6) Role-Emotional, 7) Vitality, and 8) General Health. For each scale, item scores are coded, summed, and transformed, with final values expressed as a percentage, ranging from 0 (worst health) to 100 (best health).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117737
|Contact: Pablo Bellosta-López, MScfirstname.lastname@example.org|
|Asociación de Parkinson de Aragón||Recruiting|
|Zaragoza, Spain, 50015|
|Contact: Natalia Brandín +34 620402088 email@example.com|
|Principal Investigator:||Pablo Herrero, PhD||Universidad San Jorge|