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

July 27, 2021 updated by: Carina Francisco Salgueiro, Clínica de Neurorehabilitación

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sant Cugat Del Valles, Barcelona, Spain, 08195
        • Clinica de neurorehabilitacion SL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: App group
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

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.
Active Comparator: conventional physiotherapy
usual physiotherapy treatment for 3 months
Other: Conventional physiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
week 12
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.
week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 6, 12 weeks
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
0, 6, 12 weeks
Functionality: Rankin scale
Time Frame: 0, 6, 12 weeks
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
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
0, 6, 12 weeks
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
0, 6, 12 weeks
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
0, 6, 12 weeks
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
0, 6, 12 weeks
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.
0, 6, 12 weeks
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.
0, 6, 12 weeks
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.
0, 6, 12 weeks
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.
0, 6, 12 weeks
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.
0, 6, 12 weeks
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.
0, 6, 12 weeks
number of falls in the last six weeks
Time Frame: 0, 6, 12 weeks
Balance. Higher scores means worse outcomes
0, 6, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clínica de Neurorehabilitación

Investigators

  • Principal Investigator: Carina F Salgueiro, MSc, Clínica de Neurorehabilitación

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS-2020-02
  • CORE-app (Other Identifier: Clinica de Neurorehabilitación)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

It is intended to share the data with other researchers such as the statistical team through encrypted e-mail.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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