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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600379
• Other study ID #: SHEBA-07-4780-DT-CTIL
• Status: Completed
• Phase: Phase 2
• First received: January 14, 2008
• Last updated: June 15, 2011
• Start date: January 2008
• Est. completion date: October 2010

Study information

• Verified date: June 2011
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).
Training 2/w for 9 weeks (total 18 sessions).

Locations

Country	Name	City	State
Israel	Sheba Medical Center, Strok Center	Tel Hashomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Community ambulation using Step Activity Monitor (SAM)		Baseline X2, post training (week 9-10), retention (week 20-24)	No
Primary	Gait analysis (GaitRite system) including dual task		Baseline X2, post training (week 9-10), retention (week 20-24)	No
Primary	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)	No
Primary	Timed Up and Go		Baseline X2, post training (week 9-10), retention (week 20-24)	No
Secondary	Functional Reach		Baseline X2, post training (week 9-10), retention (week 20-24)	No
Secondary	Four Stick Stepping Test (FSST)		Baseline X2, post training (week 9-10), retention (week 20-24)	No
Secondary	3DGait Analysis system		Baseline X2, post training (week 9-10), retention (week 20-24)	No
Secondary	6 minute walk		Baseline X2, post training (week 9-10), retention (week 20-24)	No
Secondary	Self-induced perturbations and reaction to perturbations on platform		Baseline X2, post training (week 9-10), retention (week 20-24)	No