ClinicalTrials.gg
CompletedNCT01774669YouGrabberUpdated Apr 7, 2016

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

A Phase 3 interventional study of YouGrabber training device from YouRehab Ltd. and Therapy (PT, OT) in Cerebrovascular Accident, Hemorrhagic Stroke and Stroke, sponsored by Reha Rheinfelden. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-07.

Primary conditionHemorrhagic StrokeRegistry: StrokeReclassifiedWhy we changed it
Registry
Stroke — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hemorrhagic Stroke
Why
  1. The study's listed conditions name Hemorrhagic Stroke, a narrower term within Stroke.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Reha Rheinfelden · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Hemorrhagic Stroke with a site in Switzerland — 3 open to participants now, 4 under way, none of them phase 3. Hemorrhagic Stroke · Switzerland.

Started
2013
the only one that year
Phase 3
2 of 12
none open now
Registered
2nd of 12
by date
Lead sponsor
1 of 12
Reha Rheinfelden

Among the 12 studies in Hemorrhagic Stroke with a site in Switzerland, this one is the only one that started in 2013, is one of 2 in phase 3, and was the 2nd registered.

Hemorrhagic Stroke

233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.

Browse Hemorrhagic Stroke studies →

Open to participants now

3 of the 12 studies in Hemorrhagic Stroke with a site in Switzerland are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 62 Hemorrhagic Stroke studies recruiting now, 36 (58%) set no upper age limit and 7 (11%) stop at 75 or younger; 5 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Hemorrhagic Stroke with a site in Switzerland, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Cerebrovascular Accident
  • Hemorrhagic Stroke
  • Stroke

Browse trials for

Keywords

  • ischemic stroke
  • hemorrhagic stroke
  • upper limb
  • virtual reality
  • physiotherapy
  • occupational therapy
04

In context

Hemorrhagic Stroke Reclassified

233 studies on the registry are indexed under Hemorrhagic Stroke; 93 are open to participants now.

This study's enrollment of 54 is close to the median of 58 across 156 interventional studies indexed under Hemorrhagic Stroke.

Browse Hemorrhagic Stroke studies →

Lead sponsor

Reha Rheinfelden is the lead sponsor of 5 studies on the registry; none are open to participants now.

Compared within Hemorrhagic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Previous or current other functional deficits of arm and hand motor function not due to stroke.
  • Severe cognitive deficits ≤ 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

06

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • 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.

  • 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)

Interventions

  • DeviceYouGrabber 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.

  • OtherTherapy (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.

07

What researchers measure

Primary outcomes

  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).

    Time frame: 15 months

Secondary outcomes

  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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 15 months

Other outcomes

  1. active range of motion (ROM)

    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

  2. Extended Barthel Index (EBI)

    Time frame: 15 months

  3. Mini Mental State Examination (MMSE)

    Time frame: 15 months

  4. Edinburgh Handedness Inventory (EHI)

    Time frame: 15 months

08

Study locations

2 sites
  • Reha Rheinfelden
    Rheinfelden, Aargau 4310, Switzerland
  • Inselspital Bern
    Bern, 3010, Switzerland
09

References and documents

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 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2013, a primary completion of Apr 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2013
First posted
Jan 24, 2013
Start
Jan 2013
Primary completionActual
Apr 2016
CompletionActual
Apr 2016
Last update
Apr 7, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01774669
Lead sponsor
Reha Rheinfelden
Collaborators
YouRehab Inc., Swiss Commission for Technology and Innovation
Responsible party
PD Dr. Daniel Kiper (Principal Investigator, University of Zurich) — Principal investigator
First posted
Jan 24, 2013
Start date
Jan 2013
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Apr 7, 2016

Study contacts

Daniel Kiper, PD PhD
principal investigator · University and ETH Zurich, Institute for Neuroinformatics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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