Stroke
Conditions
Keywords
Stroke rehabilitation, chronic stroke rehabilitation, tele-rehabilitation, telestroke, telehealth, home rehabilitation
Brief summary
Stroke is the leading cause of disability in adults worldwide. Rehabilitation after a stroke is crucial, even after the acute phase: initially, it aims to recover the deficits caused by the stroke, but in the subacute/chronic phases the objective is to maintain the functional abilities already acquired. After the acute phase, traditional rehabilitation methods usually include exercises prescribed by a therapist that the patient performs on their own. However, their effectiveness is limited due to the lack of supervision, adherence, and insufficient information provided to the patient about their progress, which would require regular in-person contact with the patient. To date, public health systems have been unable to provide this kind of access to rehabilitation for post-stroke patients, with the risk of worsening deficits and a decline in quality of life. We plan to develop an individualized home-based monitoring program enhanced by telerehabilitation based on non-immersive virtual reality (without the need for VR goggles or other gadgets) (MUVITY) for patients who suffered a stroke in the subacute/chronic phase. Patients seen during an outpatient consultation who require rehabilitation will be randomly assigned either the usual treatment (they will receive a document describing the exercises to perform and a suggested schedule, togheter with an app for communication and health-education, Nora) or the MUVITY treatment: patients will be provided with the telerehabilitation system using a computer and camera where they will perform the rehabilitation exercises, which will be individually adapted according to their progress by a physiotherapist, together with Nora. We believe that MUVITY will lead to improved motor function, emotional well-being, and quality of life, increasing adherence to rehabilitation treatment compared with usual care, and that it can be used in terms of patient satisfaction and pain levels. Our findings could confirm that telerehabilitation improves motor function and quality of life after stroke. Furthermore, since it is a home-based system, its use would considerably increase the number of patients who can receive treatment compared with in-person therapies, eliminating geographic barriers related to distance from rehabilitation centers and offering cost-effective access to effective treatment for all patients. Additionally, our system allows continuous interaction between patients and healthcare professionals, and provides information about their progress, which helps reduce stress related to uncertainty about the future and supports key aspects of monitoring patients in the subacute/chronic phase of stroke such as risk factor control and early detection of complications.
Interventions
DEVICENon- immersive virtual reality (niVR)-based telerehabilitation home program
Muvity (software of non-immersive virtual reality (niVR) through a depth camera installed in a personal computer (PC)) will be provided with a personalized treatment plan to be carried out 3times/week along 12w in the patient's home. The user will see exercises and serious games as daily quests, in a gamified environment with alerts to remind the scheduled treatment. The potential exercises include following a virtual avatar to perform individual movements (shoulder flexion-extension, shoulder vertical or horizontal abduction-adduction, elbow flexion-extension, hip flexion-extension or hip abduction-adduction), squats or medio-lateral movements of the pelvis to control the body weight transfer. The serious games are oriented toward performing movements in activities of daily living, such as cooking, cleaning a mirror, or acting as a goalkeeper, or collecting apples.
Sponsors
Nora Therapeutics, Inc.
Muvity
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Prospective, randomized, open trial with blind evaluation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years-old * Ischemic or hemorrhagic stroke within 3 to 12 months before inclusion * Inclusion modified Rankin scale 1 to 3 * Motor rehabilitation requirements defined by the stroke neurologist/physiatrist in the out-patient clinic * Bipedal standing: capable of keeping on two feet for two minutes without using hand supports.
Exclusion criteria
* Technological abilities: patient and caregiver do not manage smartphone and computer * Severe aphasia/ language barrier with patient/caregiver that impairs communication * Severe cognitive impairment (dementia) that affects short- and medium-term memory. * End-of-life- or life-threatening pathology with an estimated survival \<1 year. * Receiving intense physical therapy (rehabilitation with at least one face-to-face physical treatment/week).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median change in the Motor Fugl-Meyer and Berg Balance Scales | From baseline to the end of treatment period (12 weeks) | Description: Comparison of the median change between treatment arms in the Fugl-Meyer and Berg Balance Scales evaluated before and after treatment. The measurement will be performed in the first visit to establish a baseline in both Muvity and control arms. At the end of the treatment, a face-to-face visit by a researcher (trained occupational therapist) blinded to the treatment group will be performed, and a new evaluation of the scales will be performed. The outcome will be evaluated by the Mann-Whitney U test and Rank Transformation ANCOVA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence levels to prescribed rehabilitation protocols | At the end of the treatment period (12 weeks from baseline) | Comparison of the adherence to the prescribed rehabilitation protocols in both the Muvity and control arms. For the evaluation, automatic system data will be collected in the Muvity software for the intervention group (descriptive, no comparison). To compare the adherence between arms, a specific questionnaire has been developed and will be administered to all patients. In addition, patients in the control group will be able to register their rehabilitation sessions in a new functionality created in the Nora app. |
| Improvement in the self-perceived health status and quality of life | Baseline (before treatment initiation) and end-visit (after 12 weeks) | Comparison of the self-perceived health status and quality of life, together with pain perception during the rehabilitation treatment, in both the Muvity and control arms. In both arms, evaluation will be performed by the HRQoL(Health-Related Quality of Life), PROMIS-10 (Patient-Reported Outcomes Measurement Information System 10-Item), HADs (Hospital Anxiety and Depression Scale) and Pain-VAS (Visual Analog Scale) patient-reported outcome measurements. A baseline evaluation will be performed before treatment initiation, and a second one at the end of the treatment period. A comparison of the median scores in the different groups at the end of the study, adjusted by baseline, and a comparison of the change in the scores of each individual patient will be performed. The outcome will be evaluated by the Mann-Whitney U test and Rank Transformation ANCOVA. |
| User performance evaluation | After weeks 2 and 12 (end of study) from treatment initiation | Tracking of user performance progression through in-game metrics (e.g., level scores, duration at week 2 and 12 of treatment) in the Muvity treatment arm. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient's satisfaction and usability evaluation | End of the treatment period (after 12 weeks) | Test of patients' satisfaction and usability of the Muvity program will be performed through a Picker test-like PREM (patient-reported experience measurement) administered to patients in the interventional group |
Countries
Spain
Contacts
Primary ContactMarta Rubiera, MD PhD
Backup ContactMarián Muchada, MD PhD
Outcome results
None listed