Effectiveness Study on a Virtual Reality Based Training System for Stroke Patients (YouGrabber)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Reha Rheinfelden
Sponsor:
Collaborators:
YouRehab Inc.
Commission for Technology and Innovation
Information provided by (Responsible Party):
PD Dr. Daniel Kiper, University of Zurich
ClinicalTrials.gov Identifier:
NCT01774669
First received: January 15, 2013
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

The patient study is a phase III trial designed as a single-blinded, randomised, controlled multi-centre trial with repeated measurement events (ME). Patients will be evaluated by a blinded assessor on five occasions: twice within two weeks at baseline before intervention start (BL, T0), once after eight treatment sessions (T1), once after the intervention (T2), and once after a two month follow-up period (FU). Figure 1 illustrates the study overview.

The study focuses on the evaluation of the YouGrabber efficacy compared to conventional therapy in an outpatient setting.

Research question: Do patients after stroke in the YouGrabber training group show higher postintervention performance in the Box and Block Test (BBT) compared to patients in the conventional therapy group? Hypothesis: H0: The investigators hypothesise that there will be no group differences after 16 training sessions or after the two month follow-up period.

H1: The investigators hypothesise that there will be a group difference after the 16 training sessions and after the two month follow-up period.

Aim: The aim of the project is to design and implement a single-blinded, randomised controlled multi-centre trial comparing YouGrabber training and conventional therapy in patients after stroke.

Patients will be randomly allocated to either the experimental group (EG) or the control group (CG) after the second ME (T0). Group allocation will be based on a computer-generated randomisation list (one for each centre, (MATLAB, 2007b, Mathworks Inc., USA) created by a researcher not involved into the study. Randomisation lists and corresponding token will be stored in the clinics' pharmacy. Patients will draw a token before the first therapy session. The token will be marked and stored until study finalisation in the pharmacy.

Group allocation will remain concealed for the independent assessor until study finalisation. Patients and treating therapists will be reminded not to talk about patient's group allocation with other therapists or participants.

Patients in both study groups (EG, CG) will receive the same amount of 16 sessions lasting for 45 minutes each. During each therapy appointment patients can decide to stop the training at any time.

Patients allocated to EG will have the opportunity to participate in two semi-structured interviews to evaluate their expectations and experiences with the virtual reality therapy with YouGrabber.

Treating therapists will have the opportunity to participate in one focus group meeting to evaluate their experiences with the virtual reality training, its advantages and disadvantages. Interview and focus group participation will be voluntary.


Condition Intervention Phase
Cerebrovascular Accident
Hemorrhagic Stroke
Stroke
Device: YouGrabber training device from YouRehab Ltd.
Other: Therapy (PT, OT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the YouGrabber System Using Virtual Reality in Stroke Rehabilitation: a Single Blinded, Randomised Controlled Multi-centre Trial

Resource links provided by NLM:


Further study details as provided by Reha Rheinfelden:

Primary Outcome Measures:
  • Box and Block Test (BBT) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Patients will be evaluated by a blinded assessor on five occasions: twice within two weeks at baseline before intervention start (BL, T0), once after eight treatment sessions (T1), once after the intervention (T2), and once after a two month follow-up period (FU).


Secondary Outcome Measures:
  • Chedoke-McMaster Stroke Assessment (CMSA) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Patients will be evaluated by a blinded assessor on five occasions: twice within two weeks at baseline before intervention start (BL, T0), once after eight treatment sessions (T1), once after the intervention (T2), and once after a two month follow-up period (FU).

  • Chedoke Arm and Hand Activity Inventory (CAHAI) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Patients will be evaluated by a blinded assessor on five occasions: twice within two weeks at baseline before intervention start (BL, T0), once after eight treatment sessions (T1), once after the intervention (T2), and once after a two month follow-up period (FU).

  • Stroke Impact Scale (SIS) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Patients will be evaluated by a blinded assessor on five occasions: twice within two weeks at baseline before intervention start (BL, T0), once after eight treatment sessions (T1), once after the intervention (T2), and once after a two month follow-up period (FU).


Other Outcome Measures:
  • active range of motion (ROM) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Patients will be evaluated by a blinded assessor on five occasions: twice within two weeks at baseline before intervention start (BL, T0), once after eight treatment sessions (T1), once after the intervention (T2), and once after a two month follow-up period (FU).

  • Extended Barthel Index (EBI) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Mini Mental State Examination (MMSE) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Edinburgh Handedness Inventory (EHI) [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YouGrabber training device from YouRehab Ltd.
Patients in the experimental group (EG) will receive 16 training sessions lasting for 45 minutes each.
Device: YouGrabber training device from YouRehab Ltd.
Patients in the experimental group (EG) will receive 16 training sessions lasting for 45 minutes each. The treatment focus is the upper extremity, in particular finder and hand function, movement coordination, and speed.
Active Comparator: Conventional therapy
Patients in the control group (CG) will receive 16 therapy sessions (physiotherapy or occupational therapy) lasting for 45 minutes each.
Other: Therapy (PT, OT)
Patients in the control group (CG) will receive 16 therapy sessions physiotherapy or occupational therapy) lasting for 45 minutes each. The therapy focuses on upper limb movements, in particular finger and hand movements. Furthermore, movement coordination and speed shall be trained.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 6 months after first-ever stroke (ischemic, haemorrhagic)
  • Able to sit in a normal chair without armrests and without support of the back rest
  • Persistent motor deficit of the arm and hand confirmed by the Chedoke-McMaster Stroke Assessment (CMSA) subscale arm level 7>x=/>3 and subscale hand level 7>x=/>2.

Exclusion Criteria:

  • Previous or current other functional deficits of arm and hand motor function not due to stroke.
  • Severe cognitive deficits MMSE ≤ 20.
  • Severe spatial-visual disorders, e.g. severe visual neglect confirmed by a Line-Bisection-Test.
  • History of epileptic seizures triggered by visual stimuli (e.g. television, video games) within the last six months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774669

Contacts
Contact: Daniel Kiper, PD PhD +4144635 ext 31 29 kiper@ini.phys.ethz.ch
Contact: Corina Schuster, PhD +4161836 ext 5381 c.schuster@reha-rhf.ch

Locations
Switzerland
Reha Rheinfelden Recruiting
Rheinfelden, Aargau, Switzerland, 4310
Contact: Andrea Henneke, BSc.    +4161836 ext 5383    a.henneke@reha-rhf.ch   
Sub-Investigator: Corina Schuster, PhD         
Inselspital Bern Not yet recruiting
Bern, Switzerland, 3010
Contact: Martin L Verra, MPtSc.    +4131632 ext 3956    martin.verra@insel.ch   
Contact: Isabelle Lehmann    +4131632 ext 3956    isabelle.lehmann@insel.ch   
Sub-Investigator: Martin L Verra, MPtSc.         
Sponsors and Collaborators
Reha Rheinfelden
YouRehab Inc.
Commission for Technology and Innovation
Investigators
Principal Investigator: Daniel Kiper, PD PhD University and ETH Zurich, Institute for Neuroinformatics
  More Information

Additional Information:
No publications provided

Responsible Party: PD Dr. Daniel Kiper, Principal Investigator, University of Zurich
ClinicalTrials.gov Identifier: NCT01774669     History of Changes
Other Study ID Numbers: 2012/065, 220/12
Study First Received: January 15, 2013
Last Updated: January 21, 2013
Health Authority: Switzerland: local ethics committee Aarau

Keywords provided by Reha Rheinfelden:
ischemic stroke
hemorrhagic stroke
upper limb
virtual reality
physiotherapy
occupational therapy

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Intracranial Hemorrhages
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on September 11, 2014