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| ID | Type | Description | Link |
|---|---|---|---|
| CORE-app | Other Identifier | Clinica de Neurorehabilitación |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App group | Experimental | 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. |
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| conventional physiotherapy | Active Comparator | usual physiotherapy treatment for 3 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-core | Device | 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. |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life: EuroQol test | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carina F Salgueiro, MSc | Clínica de Neurorehabilitación | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica de neurorehabilitacion SL | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23652265 | Background | Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7. | |
| 23019591 |
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It is intended to share the data with other researchers such as the statistical team through encrypted e-mail.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2020 | Jul 13, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 8, 2020 | Jul 8, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D000075782 | Cell Phone Use |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003142 | Communication |
| D012919 | Social Behavior |
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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
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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.
|
| Conventional physiotherapy | Other | 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. |
|
| 0, 6, 12 weeks |
| Participation in Activity of Daily Living: Barthel Index | Participation in Activity of Daily Living using Barthel Index Scale. Minimum Score: 0; Maximum Score: 100. Higher score means better outcomes | 0, 6, 12 weeks |
| Functionality: Rankin scale | Functionality using Rankin Scale. Minimum Score: 0; Maximum Score: 6. Higher score means worse outcomes | 0, 6, 12 weeks |
| Sitting balance: Spanish versions of the Trunk Impairment Scale 2.0 | Sitting balance using Spanish versions of the Trunk Impairment Scale 2.0. Minimum Score: 0; Maximum Score: 26. Higher score means better outcomes | 0, 6, 12 weeks |
| Sitting balance: Function in Sitting Test | Sitting balance using Function in Sitting Test. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes | 0, 6, 12 weeks |
| Standing balance: Berg Balance Scale | Standing balance using Berg Balance Scale. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes | 0, 6, 12 weeks |
| Standing balance: Spanish version of the Postural Assessment Scale for stroke patients | Standing balance using Spanish version of the Postural Assessment Scale for Stroke patients. Minimum Score: 0; Maximum Score: 36. Higher score means better outcomes | 0, 6, 12 weeks |
| G-Walk accelerometer system: Duration of double and individual support | 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. | 0, 6, 12 weeks |
| G-Walk accelerometer system: Duration of support and swing gait phases from right anda left lower limb | 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. | 0, 6, 12 weeks |
| G-Walk accelerometer system: Cadence of stride | 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. | 0, 6, 12 weeks |
| G-Walk accelerometer system: Gait speed | 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. | 0, 6, 12 weeks |
| G-Walk accelerometer system: Step length | 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. | 0, 6, 12 weeks |
| G-Walk accelerometer system | 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. | 0, 6, 12 weeks |
| number of falls in the last six weeks | Balance. Higher scores means worse outcomes | 0, 6, 12 weeks |
| Background |
| Brewer L, Horgan F, Hickey A, Williams D. Stroke rehabilitation: recent advances and future therapies. QJM. 2013 Jan;106(1):11-25. doi: 10.1093/qjmed/hcs174. Epub 2012 Sep 27. |
| 23893833 | Background | Schmid AA, Van Puymbroeck M, Altenburger PA, Miller KK, Combs SA, Page SJ. Balance is associated with quality of life in chronic stroke. Top Stroke Rehabil. 2013 Jul-Aug;20(4):340-6. doi: 10.1310/tsr2004-340. |
| 27004638 | Background | Isho T, Usuda S. Association of trunk control with mobility performance and accelerometry-based gait characteristics in hemiparetic patients with subacute stroke. Gait Posture. 2016 Feb;44:89-93. doi: 10.1016/j.gaitpost.2015.11.011. Epub 2015 Nov 26. |
| 26451007 | Background | Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, Hernandez-Valino M, Urrutia Cuchi G. The effect of additional core stability exercises on improving dynamic sitting balance and trunk control for subacute stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1024-1033. doi: 10.1177/0269215515609414. Epub 2015 Oct 8. |
| 28351168 | Background | Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, du Port de Pontcharra-Serra H, German-Romero A, Urrutia G. Long-term follow-up of a randomized controlled trial on additional core stability exercises training for improving dynamic sitting balance and trunk control in stroke patients. Clin Rehabil. 2017 Nov;31(11):1492-1499. doi: 10.1177/0269215517701804. Epub 2017 Mar 29. |
| 24018373 | Background | Cabanas-Valdes R, Cuchi GU, Bagur-Calafat C. Trunk training exercises approaches for improving trunk performance and functional sitting balance in patients with stroke: a systematic review. NeuroRehabilitation. 2013;33(4):575-92. doi: 10.3233/NRE-130996. |
| 30654899 | Background | Chen Y, Abel KT, Janecek JT, Chen Y, Zheng K, Cramer SC. Home-based technologies for stroke rehabilitation: A systematic review. Int J Med Inform. 2019 Mar;123:11-22. doi: 10.1016/j.ijmedinf.2018.12.001. Epub 2018 Dec 11. |
| 30209991 | Background | Zhou X, Du M, Zhou L. Use of mobile applications in post-stroke rehabilitation: a systematic review. Top Stroke Rehabil. 2018 Sep 13:1-11. doi: 10.1080/10749357.2018.1482446. Online ahead of print. |
| 26703120 | Background | Sanchez Rodriguez MT, Collado Vazquez S, Martin Casas P, Cano de la Cuerda R. Neurorehabilitation and apps: A systematic review of mobile applications. Neurologia (Engl Ed). 2018 Jun;33(5):313-326. doi: 10.1016/j.nrl.2015.10.005. Epub 2015 Dec 17. English, Spanish. |
| D002561 |
| Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |