A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson

Parkinson Disease Clinical Trial

Official title:

Effects of Virtual Reality Combined With Antigravity Treadmill Rehabilitation for Gait Improvement of Patients With Parkinson's Disease: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117737
• Other study ID #: PI18/386
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: December 2019
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to improve knowledge about mechanical gait assistance combined with virtual reality efficiency in gait recovery for Parkinson´s patients. It is hypothesised that 12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill rehabilitation combined with virtual reality treatment is effective for increase gait autonomy in patients with Parkinson's disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Having Parkinson's disease diagnosed by a neurological doctor.

• Having an alteration of the gait caused by the neurological disorder.

• Being able to have an independent and voluntary walk of 10 meters as minimum.

• Height more than 150 cm.

Exclusion Criteria:

• Being blind.

• Medical contraindications for walking.

• Being amputee.

• Alcohol or drugs abuse.

• Other diseases that impedes the intervention.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Spain	Asociación de Parkinson de Aragón	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad San Jorge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in gait autonomy	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.	Baseline and 4-weeks
Secondary	Changes in gait speed	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.	Baseline and 4-weeks
Secondary	Changes in balance and gait ability	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.	Baseline and 4-weeks
Secondary	Changes in quality of life	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).	Baseline and 4-weeks