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| Name | Class |
|---|---|
| Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud | OTHER |
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The goal of this pilot study is to evaluate if a semi-inmersive virtual reality device works in the recovery of the function of the upper limb affected in hospitalized patients who have suffered a stroke.
Reseachers will compare the virtual reality device plus the usual treatment to usual treatment to see if virtual reality device works to recovery upper limb function.
Participants will be able to receive conventional treatment or virtual therapy plus conventional treatment 5 days a week for 4 weeks.
When they are discharged, they will come to the hospital 2 times to be reviewed, 3 months and 1 year after receiving treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | This arm receives the virtual therapy plus the usual treatment |
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| Control Group | Other | This arm receives the usual treatment at the same dose and time than experimental group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual therapy | Device | Virtual therapy has been applied for four weeks, three times a week. We administered a total of twelve sessions with a duration of 30 minutes each. Prior to virtual therapy experimental group have received kinesitherapy for 15 minutes to improve and prevent muscle spasticity and joint contractures. Therapists recorded the order of the session and they have providen the same external aid to all patients. Two days a week the experimental group have received the conventional treatment for 45 minutes (kinesitherapy, strengthening exercises muscle, trunk control, transfers, standing and walking). In addition to physiotherapy treatment, participants have done occupational therapy 5 days a week (training to perform ADLs, tracking techniques and search, manipulation, reach and grasping of different utensils, etc.), for 30 minutes each session. |
| Measure | Description | Time Frame |
|---|---|---|
| Upper limb motor function as assessed by Fugl-Meyer Upper-Limb scale (FM-UL) | The maximum value of the motor function in the FM-UL scale is 66 points. A higher score corresponds to a better state of operation of the patient. | at baseline, 4 weeks, 3 months and a year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Daily-life activities as assessed as Barthel Index (BI) | BI evaluates 10 daily-life activities: eating, wash, dress, groom, defecate, urinate, go to the toilet, move, chair-bed, ambulation, going up and down stairs. The total score ranges from 0 to 100. The global results are grouped into four categories of dependency: total, severe, moderate or mild. Lower score means subject has more dependence ant higher score means more independence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Regional de Malaga | Málaga | Spain |
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| Usual treatment | Other | Patients assigned to the control group have received the conventional treatment five days a week. They have done physiotherapy session and occupational therapy for 45 and 30 minutes a day each one. |
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| at baseline, 4 weeks, 3 months and a year after treatment |
| Trunk control as assessed as Control Trunk Test (TCT) | TCT is a simple test that explores four movements. Each of the sections are scored as follows: 0 points if the patient is unable to perform the movement without assistance, 12 points if able to perform the movement abnormally and 25 points if the patient is able to complete the movement normally. The total score is the sum of the results of the four tests and its value can range from 0 to 100. | at baseline, 4 weeks, 3 months and a year after treatment |
| Daily-life activities as assessed as Self-Assessment of Role Performance and Activities of Daily Living (SARA-TM) | SARA-TM is a questionnaire that users fill out with the orientation of the therapists. It is based on their perceptions of various daily-life activities. We have asked about items related to self-care, food, maintenance of postures, movement, manipulation and pain. Each one of the domains consists of different items that correspond to different activities. Each item is scored from 0 to 4 depending on the degree of difficulty in performing the activities. Lower values represent better function | at baseline, 4 weeks, 3 months and a year after treatment |