AzTrials
AzTrials

Cerebrovascular AccidentPhase 3YouGrabberNCT01774669

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

A Phase 3 study testing YouGrabber training device from YouRehab Ltd. and Therapy (PT, OT) in people with Cerebrovascular Accident and Hemorrhagic Stroke, run by Reha Rheinfelden at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
YouGrabber training device from YouRehab Ltd. and Therapy (PT, OT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
2 sitesSwitzerland
Study dates
Jan 2013to Apr 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • Inselspital Bern

    Bern, Canton of Bern, 3010

  • Reha Rheinfelden

    Rheinfelden, Canton of Aargau, 4310

Other trials in Switzerland

About this study

Official title: Effectiveness of the YouGrabber System Using Virtual Reality in Stroke Rehabilitation: a Single Blinded, Randomised Controlled Multi-centre Trial

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.

Read more

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.

Being tested
YouGrabber training device from YouRehab Ltd., Therapy (PT, OT)
Keywords
ischemic stroke, hemorrhagic stroke, upper limb, virtual reality, physiotherapy, occupational therapy
Medical subject headings
Stroke, Hemorrhagic Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YouGrabber training device from YouRehab Ltd.Device

    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.

  • Therapy (PT, OT)Other

    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.

Study groups in NCT01774669
Study groupRoleWhat they receive
YouGrabber training device from YouRehab Ltd.ExperimentalPatients in the experimental group (EG) will receive 16 training sessions lasting for 45 minutes each.
Receives: Device: YouGrabber training device from YouRehab Ltd.
Conventional therapyActive comparatorPatients in the control group (CG) will receive 16 therapy sessions (physiotherapy or occupational therapy) lasting for 45 minutes each.
Receives: Other: Therapy (PT, OT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 15 months

Secondary outcomes (3)

  1. 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).

    Measured: 15 months

  2. 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).

    Measured: 15 months

  3. 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).

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01774669
Sponsor's protocol ID
2012/065
Other IDs
220/12
Acronym
YouGrabber
Status last verified
Nov 2015
First submitted
15 Jan 2013
Last updated
7 Apr 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 30356229

  • 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.

    PubMed 25194928

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing YouGrabber training device from YouRehab Ltd. and Therapy (PT, OT) in people with Cerebrovascular Accident and Hemorrhagic Stroke, run by Reha Rheinfelden at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Box and Block Test (BBT) (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01774669, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in