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

Not Applicable

Completed

• Conditions: Gait Disorders, Neurologic; Parkinson Disease
• Interventions: Other: Virtual reality combined with anti-gravity treadmill

• Registration Number: NCT04117737
• Lead Sponsor: Universidad San Jorge

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-30
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Primary Completion: 2019-11-30
• Status Verified: 2019-12
• Study Completion: 2019-12-30
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Virtual reality combined with anti-gravity treadmill	Single-arm

Primary Outcome Measures

Name	Time	Method
Changes in gait autonomy	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.

Secondary Outcome Measures

Name	Time	Method
Changes in balance and gait ability	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 gait speed	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 quality of life	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).

Trial Locations

Locations (1)

Asociación de Parkinson de Aragón; 🇪🇸 Zaragoza, Spain