## Protocol Section
### Identification Module
**NCT ID:** NCT00600379

**Brief Title:** Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke

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

#### Organization Study ID Info
**ID:** SHEBA-07-4780-DT-CTIL
#### Organization
**Class:** OTHER_GOV
**Full Name:** Sheba Medical Center
### Status Module
#### Completion Date
**Date:** 2010-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-06-16

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-06-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-07

**Type:** ACTUAL

#### Start Date
**Date:** 2008-01

**Status Verified Date:** 2011-06

#### Study First Post Date
**Date:** 2008-01-25
**Type:** ESTIMATED
**Study First Submit Date:** 2008-01-14
**Study First Submit QC Date:** 2008-01-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Sheba Medical Center

#### Responsible Party

**Old Name Title:** Prof. David Tanne/Director, Stroke Center

**Old Organization:** Sheba Medical Center

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Stroke

**Keywords:**

- stroke chronic gait deficits virtual reality training

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 48

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

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

**Label:** A,

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Usual care

**Label:** B,

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A,

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

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

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Community ambulation using Step Activity Monitor (SAM)

**Time Frame:** Baseline X2, post training (week 9-10), retention (week 20-24)

**Measure:** Gait analysis (GaitRite system) including dual task

**Time Frame:** Baseline X2, post training (week 9-10), retention (week 20-24)

**Measure:** Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform.

**Time Frame:** Baseline X2, post training (week 9-10), retention (week 20-24)

**Measure:** Timed Up and Go

**Time Frame:** Baseline X2, post training (week 9-10), retention (week 20-24)

#### Secondary Outcomes

**Measure:** Functional Reach

**Time Frame:** Baseline X2, post training (week 9-10), retention (week 20-24)

**Measure:** Four Stick Stepping Test (FSST)

**Time Frame:** Baseline X2, post training (week 9-10), retention (week 20-24)

**Measure:** 3DGait Analysis system

**Time Frame:** Baseline X2, post training (week 9-10), retention (week 20-24)

**Measure:** 6 minute walk

**Time Frame:** Baseline X2, post training (week 9-10), retention (week 20-24)

**Measure:** Self-induced perturbations and reaction to perturbations on platform

**Time Frame:** Baseline X2, post training (week 9-10), retention (week 20-24)

### Eligibility Module

**Eligibility 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.

**Maximum Age:** 65 Years

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tel Hashomer

**Country:** Israel

**Facility:** Sheba Medical Center, Strok Center

**State:** Ramat Gan

**Zip:** 52621

#### Overall Officials

**Official 1:**

**Affiliation:** Sheba Medical Center

**Name:** David Tanne, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

### Misc Info Module

- Version Holder: 2024-05-24
