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

NCT00600379 | Completed Phase 2

• 1 other identifier: SHEBA-07-4780-DT-CTIL
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke chronic gait deficits virtual reality training

Outcome Measures

Primary Outcomes (4)

• Community ambulation using Step Activity Monitor (SAM)

  Baseline X2, post training (week 9-10), retention (week 20-24)

• Gait analysis (GaitRite system) including dual task

  Baseline 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 Go

  Baseline X2, post training (week 9-10), retention (week 20-24)

Secondary Outcomes (5)

• Functional Reach

  Baseline 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)

• 3DGait Analysis system

  Baseline X2, post training (week 9-10), retention (week 20-24)

• 6 minute walk

  Baseline X2, post training (week 9-10), retention (week 20-24)

• Self-induced perturbations and reaction to perturbations on platform

  Baseline X2, post training (week 9-10), retention (week 20-24)

Study Arms (2)

A,

EXPERIMENTAL

Virtual Reality training for an overall of 18 sessions 2/week + usual care.

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

B,

NO INTERVENTION

Usual care

Interventions

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

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

A,

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center, Strok Center

Tel Litwinsky, Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Tanne, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 16, 2011

Record last verified: 2011-06

Locations

IL (1)