Effectiveness Study on a Virtual Reality Based Training System for Stroke Patients (YouGrabber)
Primary Purpose
Cerebrovascular Accident, Hemorrhagic Stroke, Stroke
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
YouGrabber training device from YouRehab Ltd.
Therapy (PT, OT)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring ischemic stroke, hemorrhagic stroke, upper limb, virtual reality, physiotherapy, occupational therapy
Eligibility 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.
Sites / Locations
- Reha Rheinfelden
- Inselspital Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
YouGrabber training device from YouRehab Ltd.
Conventional therapy
Arm Description
Patients in the experimental group (EG) will receive 16 training sessions lasting for 45 minutes each.
Patients in the control group (CG) will receive 16 therapy sessions (physiotherapy or occupational therapy) lasting for 45 minutes each.
Outcomes
Primary Outcome Measures
Box and Block Test (BBT)
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)
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)
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)
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).
Full Information
NCT ID
NCT01774669
First Posted
January 15, 2013
Last Updated
April 6, 2016
Sponsor
Reha Rheinfelden
Collaborators
YouRehab Inc., Swiss Commission for Technology and Innovation
1. Study Identification
Unique Protocol Identification Number
NCT01774669
Brief Title
Effectiveness Study on a Virtual Reality Based Training System for Stroke Patients
Acronym
YouGrabber
Official Title
Effectiveness of the YouGrabber System Using Virtual Reality in Stroke Rehabilitation: a Single Blinded, Randomised Controlled Multi-centre Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Reha Rheinfelden
Collaborators
YouRehab Inc., Swiss Commission for Technology and Innovation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Hemorrhagic Stroke, Stroke
Keywords
ischemic stroke, hemorrhagic stroke, upper limb, virtual reality, physiotherapy, occupational therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
YouGrabber training device from YouRehab Ltd.
Arm Type
Experimental
Arm Description
Patients in the experimental group (EG) will receive 16 training sessions lasting for 45 minutes each.
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
Patients in the control group (CG) will receive 16 therapy sessions (physiotherapy or occupational therapy) lasting for 45 minutes each.
Intervention Type
Device
Intervention Name(s)
YouGrabber training device from YouRehab Ltd.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Therapy (PT, OT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Box and Block Test (BBT)
Description
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).
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Chedoke-McMaster Stroke Assessment (CMSA)
Description
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).
Time Frame
15 months
Title
Chedoke Arm and Hand Activity Inventory (CAHAI)
Description
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).
Time Frame
15 months
Title
Stroke Impact Scale (SIS)
Description
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).
Time Frame
15 months
Other Pre-specified Outcome Measures:
Title
active range of motion (ROM)
Description
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).
Time Frame
15 months
Title
Extended Barthel Index (EBI)
Time Frame
15 months
Title
Mini Mental State Examination (MMSE)
Time Frame
15 months
Title
Edinburgh Handedness Inventory (EHI)
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Kiper, PD PhD
Organizational Affiliation
University and ETH Zurich, Institute for Neuroinformatics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reha Rheinfelden
City
Rheinfelden
State/Province
Aargau
ZIP/Postal Code
4310
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
30356229
Citation
Schuster-Amft C, Eng K, Suica Z, Thaler I, Signer S, Lehmann I, Schmid L, McCaskey MA, Hawkins M, Verra ML, Kiper D. Effect of a four-week virtual reality-based training versus conventional therapy on upper limb motor function after stroke: A multicenter parallel group randomized trial. PLoS One. 2018 Oct 24;13(10):e0204455. doi: 10.1371/journal.pone.0204455. eCollection 2018.
Results Reference
derived
PubMed Identifier
25194928
Citation
Schuster-Amft C, Eng K, Lehmann I, Schmid L, Kobashi N, Thaler I, Verra ML, Henneke A, Signer S, McCaskey M, Kiper D. Using mixed methods to evaluate efficacy and user expectations of a virtual reality-based training system for upper-limb recovery in patients after stroke: a study protocol for a randomised controlled trial. Trials. 2014 Sep 6;15:350. doi: 10.1186/1745-6215-15-350.
Results Reference
derived
Links:
URL
http://www.reha-rheinfelden.ch/
Description
Home page of participating cite.
Learn more about this trial
Effectiveness Study on a Virtual Reality Based Training System for Stroke Patients
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