Virtual Reality Task Oriented Training on Upper Limb Function in Stroke Patients

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQilu Hospital of Shandong University

About this trial

Stroke rank second among the top causes of death, affecting millions of people in the worldwide. It has been reported that hemiplegia is the most common sequelae after stroke, accounting for about 50%-70% of all sequelae of the disease. About 75% of stroke patients are accompanied by different degrees of upper limb dysfunction, which seriously affects the activities of daily life and cause serious physical and mental burden to patients and their families. Early recovery of upper limb motor function is a great significance for the overall recovery of stroke patients. Task-oriented training (TOT) is reported to improve the motor coordination and ADL. However, lack varies of tasks limited the treatment ability for patients with stroke hemiplegia during hospital admission. Virtual reality (VR) offers advantages of providing virtual scenes that is difficult in the real world, such as the scene of garden, camara, and plaza etc. And the familiar circumstances for patients may have the potential to increase the motivation of rehabilitation training, and improve the efficacy of occupational therapy (OT).

The goal of this study is to observe the effectiveness of real home settings via virtual reality assisted TOT on upper limb function in patients with stroke. Functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG) were used to observe the changes in brain function under VR-TOT training.

We intended to recruit 120 participants, and allocate to three groups: VR-TOT, TOT, and traditional OT. Each of them completed the Fugl-Meyer-UE, Wolf motor function test (WMFT), hand gripping power, modified Ashworth、Purdue Pegboard test (PPT)、modified Barthel index (MBI)、mini mental state examination (MMSE)、NIH stroke scale (NIHSS)、Virtual reality sickness questionnaire (VRSQ), Intrinsic Motivation Inventory Inventory (IMI), satisfaction VAS, body representation, sense of ownership, Proprioceptive Drift scale before and after the treatment. Additionally, we conducted fNIRS and EEG at baseline and during the follow up to understand the changes in brain function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

1. Previous history of stroke, traumatic or non-vascular encephalopathy; 2. MOCA ≤ 17, and no sensory aphasia. 3. Skull defect or allogeneic repair; 4. combined with other neurological and mental diseases; 5. Previous diseases that may cause upper limb motor/sensory dysfunction, such as neck tumor or radiotherapy and chemotherapy history, cervical spondylosis, cervical spine or upper limb fracture history, traumatic brachial plexus injury history, arthritis, diabetes mellitus, myasthenia gravis, multiple sclerosis, etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • virtual reality (VR) head mounted display

    Device

    The participants' in this group were given VR-TOT training under real home scenes created in the platform of Unity. There were 6 VR-TOT tasks, and the task choice was according to the performance of participants' upper limb function. The experienced therapist will guide and monitor the participants and adjust the task if necessary.

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: VR+TOT (task oriented training combined with occupational training)Experimental treatment 1 intervention
Group B: Traditional OTNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Fugl-Meyer Assessment Upper Extremity Scale (FAM-UE)

Time frame
There were 4 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks,1 month after the intervention

Secondary outcomes

1

The grip strength of the hand

Time frame
There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
2

the Modified Ashworth scale

Time frame
There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
3

Montreal Cognitive Assessment(MoCA)

Time frame
There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks
4

Box and Block Test(BBT)

Time frame
There were 3 time points for evaluation:after screening for enrollment but before study initiation,the intervention of 2 weeks, the intervention of 4 weeks

Other outcomes

1

National Institute of Health Stroke Scale(NIHSS)

Time frame
after screening for enrollment but before study initiation
2

the Virtual Reality Symptom Questionnaire(VRSQ)

Time frame
There were 3 time points for evaluation: after the first day of treatment, the intervention of 2 weeks, the intervention of 4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Hospital of Shandong University

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Collaborator

Shanghai Sunshine Rehabilitation Center

Collaborator

Beihang University

Collaborator

Huashan Hospital

Collaborator

Jinan Hospital

Collaborator

Jinan Seventh People's Hospital

Collaborator