Spinal cord injury Injury, Occupational Diseases, Poisoning Tetraplegia, unspecified
Conditions
Interventions
All participants receive conventional therapy, consisting of routine occupational therapy and physiotherapy (e.g. active and passive mobilisations, strengthening exercises of the upper limb (UL) and a
Sponsors
National Spinal Cord Injury Hospital - SESCAM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 and over 2. Less than 12 months from the injury 3. Motor complete spinal cord injury according to the American Spinal Injury Association (ASIA) impairment scale at the level of C5 to C8 (A-B ASIA level)
Exclusion criteria
Exclusion criteria: 1. History of traumatic or cognitive pathology that can affect UL movements 2. Technology addiction 3. Epilepsy 4. Pregnancy 5. Normal or corrected-to normal vision and hearing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in upper limb function. All participants are evaluated twice: at the beginning of the study and at the end, using a set of clinical and functional scales. The evaluation is performed the day before starting the VR treatment (pre-assessment) and the day after finishing (post-assessment). A sample from each group will be followed up and assessed 3 months after the study (follow up-assessment), to measure the stability of the changes. In this period both groups continue with conventional therapy. The functional examination uses four scales: 1. The Functional Independence Measure (FIM) consisting of 18 items organised in six categories, four corresponding to motor functions (self-care items, sphincter control, mobility items, and locomotion) and two corresponding to cognitive functions (communication, psychosocial, and cognitive). The lowest and highest scores of the total ranged from 18 to 126. 2. The Spinal Cord Injury Independence Measure (SCIM III) has 16 items divided into three functional areas: self-care, respiration and sphincter management, and mobility. Total score can vary from 0 (minimal) to 100 (maximal). Only the self-care sub-score has been considered in this study, because it has been previously shown that the self-care category of the SCIM III and several of its items correlate well with UL strength and capacity tests in persons with tetraplegia. 3. The Barthel Index (BI) consists of 10 items: eating, bathing, grooming, dressing, bowels, bladder, toilet use, transfers (bed to chair and back), mobility (on level surfaces) and stairs. Total score is from 0 to 100. 4. Motricity Index (MI) which assesses power and range of active movement rated for shoulder abduction, elbow flexion, and pinch between the thumb and index finger. Each movement is rated on a 0-100 point scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction with the virtual reality rehabilitation system. The level of satisfaction is assessed after VR training in the experimental group using the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST), an instrument specifically designed to measure satisfaction with a broad range of assistive technology devices in a structured and standardised way. The test includes 12 items, related to device characteristics (n=8) and assistive technology services (n=4). The scoring method rates from 1 (not satisfied at all) to 5 (very satisfied). Only the items related to device characteristics are used for this study, due to the lack of external assistive services. Therefore, the maximum possible score is 5 for each item, and 35 for the total scale. We also use a satisfaction survey (Likert scale) to identify the satisfaction not only with the VR systems features, but also with the rehabilitation and functional aspects related to VR systems. The Likert scale consists of 20 items rated from 0 (not satisfied at all) to 5 (very satisfied), including questions about systems features, VR activities and motivation. The maximum possible score is 5 for each item, and 100 for the total scale. | — |
Countries
Spain
Outcome results
None listed