Clinical trial NCT04477252: Mobile App as a Guide to Exercises for Patients With Chronic Stroke
Official title: Mobile App as a Guide to Lumbopelvic Stability Exercises in Patients With Chronic Stroke: a Pilot Study of a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telerehabilitation
Stroke Sequelae
Therapeutic Adherence and Compliance
Mobile Phone Use
Physical Disability
Neurologic Disorder
Keywords: Mobile Applications
Telerehabilitation
Stroke
Therapeutics
Functional recovery
Neurorehabilitation
Lead sponsor: Clínica de Neurorehabilitación
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence: Scale of System Uses
timeFrame: week 12
measure: Adherence: Administration panel of the App
timeFrame: week 12
Secondary outcomes:
Other outcomes:
measure: Quality of Life: EuroQol test
timeFrame: 0, 6, 12 weeks
measure: Participation in Activity of Daily Living: Barthel Index
timeFrame: 0, 6, 12 weeks
measure: Functionality: Rankin scale
timeFrame: 0, 6, 12 weeks
measure: Sitting balance: Spanish versions of the Trunk Impairment Scale 2.0
timeFrame: 0, 6, 12 weeks
measure: Sitting balance: Function in Sitting Test
timeFrame: 0, 6, 12 weeks
measure: Standing balance: Berg Balance Scale
timeFrame: 0, 6, 12 weeks
measure: Standing balance: Spanish version of the Postural Assessment Scale for stroke patients
timeFrame: 0, 6, 12 weeks
measure: G-Walk accelerometer system: Duration of double and individual support
timeFrame: 0, 6, 12 weeks
measure: G-Walk accelerometer system: Duration of support and swing gait phases from right anda left lower limb
timeFrame: 0, 6, 12 weeks
measure: G-Walk accelerometer system: Cadence of stride
timeFrame: 0, 6, 12 weeks
measure: G-Walk accelerometer system: Gait speed
timeFrame: 0, 6, 12 weeks
measure: G-Walk accelerometer system: Step length
timeFrame: 0, 6, 12 weeks
measure: G-Walk accelerometer system
timeFrame: 0, 6, 12 weeks
measure: number of falls in the last six weeks
timeFrame: 0, 6, 12 weeks
Locations:
city: Sant Cugat Del Valles
country: Spain
facility: Clinica de neurorehabilitacion SL
state: Barcelona
Study officials:
affiliation: Clínica de Neurorehabilitación
name: Carina F Salgueiro, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.