Mobile App as a Guide to Exercises for Patients With Chronic Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mobile App as a Guide to Lumbopelvic Stability Exercises in Patients With Chronic Stroke: a Pilot Study of a Randomized Clinical Trial

Conditions
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Telerehabilitation, Stroke Sequelae, Therapeutic Adherence and Compliance, Mobile Phone Use, Physical Disability, Neurologic Disorder

Intervention / Treatment
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* Device: App-core
* Other: Conventional physiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App group<br>Use of the Mobile App for the daily performance (Monday to Friday) of lumbopelvic stability exercises apart from the usual physiotherapy treatment for 3 months. | Device: App-core<br>* 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.<br>|
| Active Comparator: conventional physiotherapy<br>usual physiotherapy treatment for 3 months | Other: Conventional physiotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence: Scale of System Uses | 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) | week 12 | 
| Adherence: Administration panel of the App | 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. | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Neurorehabilitation, Mobile Applications, Telerehabilitation, Therapeutics, Functional recovery