Mobile Phone Use, Neurologic Disorder, Physical Disability, Stroke Sequelae, Telerehabilitation, Therapeutic Adherence and Compliance
Conditions
Keywords
Mobile Applications, Telerehabilitation, Stroke, Therapeutics, Functional recovery, Neurorehabilitation
Brief summary
Introduction: Stroke continues to be one of the leading causes of disability in the Spanish adult population with the presentation of impairments such as alteration of mobility and a consequent reduction in quality of life. These sequelae, generally chronic, generates a significant expense and saturation of social and health services. With the growth in the number of cases, the development of new rehabilitation approaches and updating of the social context becomes pertinent, such as the incorporation of telerehabilitation to assist individuals with stroke. Objectives: To analyze adherence to physical rehabilitation by mobile App and to evaluate the effectiveness of lumbopelvic stability exercises performed at home with the App. Material and methods: Randomized controlled single blind pilot study (n = 30). Participants with Stroke (\<6 months) will be randomized between two groups (App for carrying out lumbopelvic stability exercises + usual treatment versus usual treatment). The study will last 3 months and App adherence, Quality Of Life, participation in Daily Life, functionality, sitting balance, standing balance and gait will be taken as variables. Expected results: It is thought that the use of an App can contribute to rehabilitation in its chronic phase, monitorization and fallow-up the clinical evolution of the patient. Even if chronicity leads us to think about the stabilization of the physical condition, It is thought that the best results will be found among the subjects who will use the App.
Detailed description
The recruitment of participants will be done in a personalized way through a verbal invitation from the responsible therapist. The therapists of the center will be informed about the inclusion criteria in this study in order to proceed with the personalized invitation. In the case that the participant meet the inclusion criteria and wishes to participate in the study, the professional evaluator is contacted to begin the process of submission in this study. The professional evaluator has the responsibility to explain to the participant what the study consists of The professional evaluator is responsible for giving the participant the study information sheet (approved by the ethics committee and the management of the center where the study will be conducted). The professional evaluator is responsible for collecting the signature of the informed consent to participate in this study (approved by the ethics committee and the management of the center where the study will be conducted). A numerical code (from 1 to 30) will be assigned to each patient according to the order of recruitment to keep their identity secret. The code attributed to each participant will appear in the individual data collection notebook The association between the participant's identity and the attributed code will be known by the professional evaluator The code attributed to each participant will be entered in the spreadsheet where the collected data and results of the assessment tests will be uploaded.
Interventions
DEVICEApp-core
Farmalarm App of the Inmovens group - Vall d´Hebrón Hospital will be used, adapted and updated by the main researcher. The App will have the rehabilitation option where the user can consult the description of the exercise and view a demonstration video so that it can be carried out correctly at home, independently or with help. The administrator therapist of the App has the permission to create users, contact them directly through chat or video-call and personalize the exercise program. The exercises that will be carried out in this study phase, are described in previous studies by the author Rosa Cabanas et al. All possible exercises will be included in the administration platform, and according to of each user, the prescription of some exercises or others will be made.
OTHERConventional physiotherapy
Conventional physiotherapy is considered neuromotor development therapy as the most frequently used therapy in the management of stroke patients and in the center where the study is performed.
Sponsors
Clínica de Neurorehabilitación
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
The therapist responsible for the conventional treatment of the patient and the therapist who performs the assessment will not have access to information about the study group the patient encounters. Since the randomization of patients, access to the intervention of the Experimental Group will be facilitated by the researcher on an occasion other than the initial assessment.
Intervention model description
In this simple blind randomized controlled pilot study, participants will be recruited from users of the rehabilitation center where the study will be carried out (Neurorehabilitation Clinic - Sant Cugat del Vallés). 30 participants will be recruited. In the recruitment process, patients will be informed about the study, they will be asked to sign an informed consent and the randomization between the experimental group and the control group will be done by computerized program and with the following interventions
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medical diagnosis of stroke with cortical or subcortical, ischemic or hemorrhagic involvement with more than 6 months of evolution * Clinical symptoms of hemiplegia or hemiparesis * Over 18 years of age * Ability to understand and execute simple instructions * Score equal to or less than 10 in the Spanish version of the Trunk Impairment Scale 2.0 * Be a frequent user of smartphone or tablet. Failing this, the direct family member / caregiver is considered.
Exclusion criteria
* Appearance of any disease or aggravation of any of the comorbidities that the patient presents that prevents rehabilitation (example: dialysis) * Suffer a second episode of Stroke. * Fractures in any of the lower extremities or important structural alterations in the trunk. * Death
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence: Scale of System Uses | week 12 | Adherence to the use of the mobile App using Scale of System Uses. Minimum Score:0 Maximum Score: 100 (higher scores mean a better result) |
| Adherence: Administration panel of the App | week 12 | Adherence to the use of the mobile App using the data extracted by the administration panel of the App. Consider 5 days / week the optimal use (100%) and a total use of 0 to 20 days in 12 weeks will be considered low adherence (0-33%), 21 to 41 days (33-66%) regular adherence and 42 to 60 days (66-100% :) good adherence. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functionality: Rankin scale | 0, 6, 12 weeks | Functionality using Rankin Scale. Minimum Score: 0; Maximum Score: 6. Higher score means worse outcomes |
| Sitting balance: Spanish versions of the Trunk Impairment Scale 2.0 | 0, 6, 12 weeks | Sitting balance using Spanish versions of the Trunk Impairment Scale 2.0. Minimum Score: 0; Maximum Score: 26. Higher score means better outcomes |
| Sitting balance: Function in Sitting Test | 0, 6, 12 weeks | Sitting balance using Function in Sitting Test. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes |
| Standing balance: Berg Balance Scale | 0, 6, 12 weeks | Standing balance using Berg Balance Scale. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes |
| Standing balance: Spanish version of the Postural Assessment Scale for stroke patients | 0, 6, 12 weeks | Standing balance using Spanish version of the Postural Assessment Scale for Stroke patients. Minimum Score: 0; Maximum Score: 36. Higher score means better outcomes |
| G-Walk accelerometer system: Duration of double and individual support | 0, 6, 12 weeks | Duration of double and individual support (%). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results. |
| Quality of Life: EuroQol test | 0, 6, 12 weeks | Quality of Life using EuroQol 5d5l. This questionnaire is made up of two parts. Part I: One part with 5 questions scored from 1 to 5 (1 represents absence of problem and 5 the absolute limitation). The total score ranges from 5 to 25 in which higher results represent a worse outcome. Part II: Consisting of a numerical scale from 0 to 100 on the general state of health, in which 0 represents the worst level of health and 100 the best level of health that individuals can perceive. |
| G-Walk accelerometer system: Cadence of stride | 0, 6, 12 weeks | Cadence of stride (steps/minutes). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results. |
| G-Walk accelerometer system: Gait speed | 0, 6, 12 weeks | Gait speed (metres/second).The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results. |
| G-Walk accelerometer system: Step length | 0, 6, 12 weeks | Step length (%). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results. |
| G-Walk accelerometer system | 0, 6, 12 weeks | Stride length (meters). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results. |
| number of falls in the last six weeks | 0, 6, 12 weeks | Balance. Higher scores means worse outcomes |
| G-Walk accelerometer system: Duration of support and swing gait phases from right anda left lower limb | 0, 6, 12 weeks | Duration of support and swing gait phases from right anda left lower limb(%). The software provides the values from subjects and the mean values of the population. It will be take into account the difference between the subject values and the mean in the population without pathology. Higher scores means worse results. |
| Participation in Activity of Daily Living: Barthel Index | 0, 6, 12 weeks | Participation in Activity of Daily Living using Barthel Index Scale. Minimum Score: 0; Maximum Score: 100. Higher score means better outcomes |
Countries
Spain
Outcome results
None listed