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

C

Clínica de Neurorehabilitación

Status

Completed

Conditions

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

Treatments

Device: App-core
Other: Conventional physiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04477252
CORE-app (Other Identifier)
FIS-2020-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

App group
Experimental group
Description:
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.
Treatment:
Device: App-core
conventional physiotherapy
Active Comparator group
Description:
usual physiotherapy treatment for 3 months
Treatment:
Other: Conventional physiotherapy

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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