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Table 2 Description of study interventions based on the TIDieR template a

From: 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

Item

Experimental group

Control group

1

Brief name

VR training system

Conventional therapy

2

Why

Both interventions will be compared directly in chronic stroke patients for two reasons:

1.One-to-one therapy sessions in an adequate amount are limited by health insurance company restrictions.

2.If VR technology is used, and YG in particular, patients and therapists will want to know if the treatment effect is the same. If yes, YG could be used to increase the amount of training time with the technology, or it could be recommended as group- or home-based VR training, which would not be the case if YG performed worse.

3

What: materials

EG patients will sit in front of the VR system (see Figure 2). They will wear hand gloves with attached sensors to measure finger movements of the thumb, index finger, middle finger, wrist (bending, extending) and lower upper limb (pronation, supination). Movements will be displayed on the screen in real time.

No restrictions will be placed on the material used (for example, ADL material, reaching and grasping material). Use of additional electrical or mechanical therapy devices (for example, help arm systems, splints) should be avoided.

4

What: procedures

The VR system has a variety of training applications for different movements and at different levels of difficulty. Therapists can select one of three modes to control the on-screen finger and arm movements: (1) use of the real arm and/or hand movements, (2) mirroring of the real movements of one arm and/or hand and (3) following the movements of one arm and/or hand. The distribution and speed of the appearing objects can be attuned. Furthermore, patients’ movements can be amplified or modulated in the virtual environment to force decreases or increases in training difficulty [9]. After the second VR training session, patients should have tested all training applications and all three modes of finger and/or hand movements. In the remaining 14 sessions, therapists will be asked to select at least 3 training applications for each training session and 2 different movement modes with settings adapted to each patient’s needs.

The therapy content will focus on a task-related upper-limb treatment in a sitting or lying position. Several manual techniques, therapy materials and objects of ADL will be allowed for treatment [10, 11].

5

Who provides

Both study interventions will be provided by experienced physiotherapists or occupational therapists, who will have at least 2 years of professional experience in the field of neurorehabilitation.

6

How

Both study interventions will be conducted individually in one-to-one sessions.

7

Where

Both study interventions will take place in the physiotherapy or occupational therapy department of each participating centre.

8

When and how much

During the 4-week intervention program, patients in both study groups (EG, CG) will receive the same amount of 16 sessions lasting 45 minutes each.

9

Tailoring

Training and therapy content will be tailored to each patients preferences, the agreed movement aims and the motor function level of each patient.

  1. aADL, Activities of daily living; CG, Control group; EG, Experimental group; TIDieR, Template for Intervention Description and Replication checklist and guide; VR, Virtual reality; YG, YouGrabber. Items 10, 11 and 12 of the TIDieR template do not apply to this study.