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

NCT01774669 | Completed Phase 3

• 2 other identifiers: 2012/065220/12
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebrovascular Accident; Hemorrhagic Stroke; Stroke

Keywords

ischemic stroke; hemorrhagic stroke; upper limb; virtual reality; physiotherapy; occupational therapy

Outcome Measures

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).

  15 months

Secondary Outcomes (3)

• Chedoke-McMaster Stroke Assessment (CMSA)

  15 months

• Chedoke Arm and Hand Activity Inventory (CAHAI)

  15 months

• Stroke Impact Scale (SIS)

  15 months

Other Outcomes (4)

• active range of motion (ROM)

  15 months

• Extended Barthel Index (EBI)

  15 months

• Mini Mental State Examination (MMSE)

  15 months

Study Arms (2)

YouGrabber training device from YouRehab Ltd.

EXPERIMENTAL

Patients in the experimental group (EG) will receive 16 training sessions lasting for 45 minutes each.

Device: YouGrabber training device from YouRehab Ltd.

Conventional therapy

ACTIVE COMPARATOR

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

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.

YouGrabber training device from YouRehab Ltd.

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.

Conventional therapy

Eligibility Criteria

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

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reha Rheinfelden: lead
• YouRehab Inc.: collaborator
• Swiss Commission for Technology and Innovation: collaborator

Study Sites (2)

Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

Location

Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 30356229 DERIVED

• 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.

  PMID: 25194928 DERIVED

Related Links

• Home page of participating cite.

MeSH Terms

Conditions

Stroke; Hemorrhagic Stroke; Ischemic Stroke

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Kiper, PD PhD

  University and ETH Zurich, Institute for Neuroinformatics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 24, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 7, 2016

Record last verified: 2015-11

Locations

CH (2)