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

S

Sheba Medical Center

Status and phase

Completed
Phase 2

Conditions

Stroke

Treatments

Device: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).

Study type

Interventional

Funder types

Other

Identifiers

NCT00600379
SHEBA-07-4780-DT-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

48 participants in 2 patient groups

A,
Experimental group
Description:
Virtual Reality training for an overall of 18 sessions 2/week + usual care.
Treatment:
Device: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).
B,
No Intervention group
Description:
Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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