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Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke

A Randomized Controlled Trial of a Virtual Reality Training Program for Ambulatory Patients With Mild-to-moderate Chronic Gait Deficits After Stroke

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00600379
Enrollment
48
Registered
2008-01-25
Start date
2008-01-31
Completion date
2010-10-31
Last updated
2011-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke chronic gait deficits virtual reality training

Brief summary

The purpose of this study is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.

Detailed description

Virtual reality (VR) systems enable the learning of simple and complex skills in a controlled virtual environment; i.e., one in which the different components (constraints) of the environment can be displayed, graded, changed and monitored in a quantitative manner. Small preliminary studies suggest that VR may be used to augment chronic stroke rehabilitation and may enhance cortical reorganization. Our aim is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke. Study design-a single center randomized controlled trial of an experimental group and a usual care group.

Interventions

DEVICEVirtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).

Training 2/w for 9 weeks (total 18 sessions).

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Main Inclusion Criteria: * Stroke within 3-72 months. * Mild-to-moderate residual gait deficits after the index stroke with preserved capacity for ambulation without or with an assistive device (e.g., walker, cane) or orthotics (e.g. AFO). Main

Exclusion criteria

* Unstable cardiac or other medical condition or aphasia, dementia or other significant neurological disease limiting ability to train.

Design outcomes

Primary

MeasureTime frame
Community ambulation using Step Activity Monitor (SAM)Baseline X2, post training (week 9-10), retention (week 20-24)
Gait analysis (GaitRite system) including dual taskBaseline X2, post training (week 9-10), retention (week 20-24)
Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform.Baseline X2, post training (week 9-10), retention (week 20-24)
Timed Up and GoBaseline X2, post training (week 9-10), retention (week 20-24)

Secondary

MeasureTime frame
3DGait Analysis systemBaseline X2, post training (week 9-10), retention (week 20-24)
Four Stick Stepping Test (FSST)Baseline X2, post training (week 9-10), retention (week 20-24)
6 minute walkBaseline X2, post training (week 9-10), retention (week 20-24)
Self-induced perturbations and reaction to perturbations on platformBaseline X2, post training (week 9-10), retention (week 20-24)
Functional ReachBaseline X2, post training (week 9-10), retention (week 20-24)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026