REWIRE - Rehabilitative Wayout In Responsive Home Environments, A Pilot Trial

NCT02192125 | Completed Early Phase 1

• 1 other identifier: 2014-061
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The study examines the possible application of the rehabilitation platform REWIRE.

Conditions

Stroke

Keywords

stroke; rehabilitation; balance; training; posture

Outcome Measures

Primary Outcomes (1)

• Proof of concept

  Technical and practical implementation of the rehabilitation platform REWIRE will be evaluated, by a questionnaire.

  week 12

Secondary Outcomes (1)

• Quality of life

  week 12

Other Outcomes (1)

• functional recovery

  week 12

Study Arms (1)

REWIRE-System

EXPERIMENTAL

The training system consists of a so-called Tymoplate® (Tyromotion, Austria), a medical device class 1 with CE certification and approval by the FDA for use in neurorehabilitation after stroke. The Tymoplate® is connected to a computer and allows by means of a base plate with integrated pressure sensors and custom-developed training software different postural biofeedback exercise.

Device: REWIRE-System

Interventions

REWIRE-System DEVICE

The REWIRE rehabilitation platform consists of three hierarchical components: 1. "patient station" (PS), which is installed in the home environment of the patient: Includes: Laptop with software - Game Tymoplate® - balanceboard Kinect® - 3D tracking 2. "Hospital Station" (HS), which allows an exchange of information with more "patient station" and is served by the therapists in the hospital; Includes: Laptop MySQL- database 3. "station networking" (NS), which allows a combination of a several of HS. database

Also known as: Tymoplate®, Kinect®

REWIRE-System

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• First-time ischemic stroke
• Moderate, residual motor deficits of the lower extremity (FAC\> 3, 6-min walk ≥ 200 m; Berg Balance Scale 21-52)
• Ability and willing to participate in the study
• signed consent form

You may not qualify if:

• Other neurological disorders (eg Parkinson's disease, dementia, multiple sclerosis, peripheral nerve damage, etc.)
• Moderate to severe aphasia
• moderate to severe unilateral neglect
• Severe dementia, MMSE ≤ 20 points
• Severe depression or psychiatric disorders
• Other serious diseases, such as severe kidney or liver dysfunction, or serious dysfunction of the cardiovascular system
• Relevant loss of vision that can not be compensated by aids, eg Hemianopia, visual acuity ≤ 20%
• Severe pain,\> 6 points on the visual analog scale
• Pregnancy

Sponsors & Collaborators

• University of Zurich: lead
• University of Milan: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator
• University of Oxford: collaborator
• University of Padova: collaborator
• Swiss Federal Institute of Technology: collaborator
• Ab.Acus Srl: collaborator
• Fundación Pública Andaluza Progreso y Salud: collaborator
• Technogym SpA: collaborator
• Fundació Privada Barcelona Digital Centre Tecnològic (BDIGITAL): collaborator
• University Hospital, Zürich: collaborator
• JSI Research & Training Institute, Inc.: collaborator
• Hospitales Universitarios Virgen del Rocío: collaborator

Study Sites (1)

Cerneo

Vitznau, Canton of Lucerne, 6354, Switzerland

Location

Related Links

• REWIRE is a European Project funded by the Seventh Framework Program, that develops, integrates and field tests an innovative virtual reality based rehabilitation platform system based on a multi-level rehabilitation platform

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea R Luft, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: July 16, 2014
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 15, 2015

Record last verified: 2015-05

Locations

CH (1)