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Completed

NCT Number: NCT04477252

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

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.

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Key information

Conditions

Telerehabilitation Behavior Brain Diseases Cardiovascular Diseases Cell Phone Use Central Nervous System Diseases Cerebrovascular Disorders Communication Health Behavior Mobile Phone Use Nervous System Diseases Neurologic Disorder Physical Disability Social Behavior Stroke Stroke Sequelae Therapeutic Adherence and Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica de neurorehabilitacion SL

Sant Cugat del Vallès, Barcelona, 08195, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Adherence: Scale of System Uses

    Time frame: 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)

  2. Adherence: Administration panel of the App

    Time frame: 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 outcomes

  1. Quality of Life: EuroQol test

    Time frame: 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.

  2. Participation in Activity of Daily Living: Barthel Index

    Time frame: 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

  3. Functionality: Rankin scale

    Time frame: 0, 6, 12 weeks

    Functionality using Rankin Scale. Minimum Score: 0; Maximum Score: 6. Higher score means worse outcomes

  4. Sitting balance: Spanish versions of the Trunk Impairment Scale 2.0

    Time frame: 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

  5. Sitting balance: Function in Sitting Test

    Time frame: 0, 6, 12 weeks

    Sitting balance using Function in Sitting Test. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes

  6. Standing balance: Berg Balance Scale

    Time frame: 0, 6, 12 weeks

    Standing balance using Berg Balance Scale. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes

  7. Standing balance: Spanish version of the Postural Assessment Scale for stroke patients

    Time frame: 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

  8. G-Walk accelerometer system: Duration of double and individual support

    Time frame: 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.

  9. G-Walk accelerometer system: Duration of support and swing gait phases from right anda left lower limb

    Time frame: 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.

  10. G-Walk accelerometer system: Cadence of stride

    Time frame: 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.

  11. G-Walk accelerometer system: Gait speed

    Time frame: 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.

  12. G-Walk accelerometer system: Step length

    Time frame: 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.

  13. G-Walk accelerometer system

    Time frame: 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.

  14. number of falls in the last six weeks

    Time frame: 0, 6, 12 weeks

    Balance. Higher scores means worse outcomes

Sponsors and collaborators

Lead sponsor

Clínica de Neurorehabilitación

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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