search
Back to results

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

Primary Purpose

Telerehabilitation, Stroke Sequelae, Therapeutic Adherence and Compliance

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
App-core
Conventional physiotherapy
Sponsored by
Clínica de Neurorehabilitación
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telerehabilitation focused on measuring Mobile Applications, Telerehabilitation, Stroke, Therapeutics, Functional recovery, Neurorehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinica de neurorehabilitacion SL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

App group

conventional physiotherapy

Arm 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.

usual physiotherapy treatment for 3 months

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2020
Last Updated
July 27, 2021
Sponsor
Clínica de Neurorehabilitación
search

1. Study Identification

Unique Protocol Identification Number
NCT04477252
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clínica de Neurorehabilitación

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telerehabilitation, Stroke Sequelae, Therapeutic Adherence and Compliance, Mobile Phone Use, Physical Disability, Neurologic Disorder
Keywords
Mobile Applications, Telerehabilitation, Stroke, Therapeutics, Functional recovery, Neurorehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Care ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
App group
Arm Type
Experimental
Arm 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.
Arm Title
conventional physiotherapy
Arm Type
Active Comparator
Arm Description
usual physiotherapy treatment for 3 months
Intervention Type
Device
Intervention Name(s)
App-core
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
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 Outcome Measure Information:
Title
Adherence: Scale of System Uses
Description
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)
Time Frame
week 12
Title
Adherence: Administration panel of the App
Description
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.
Time Frame
week 12
Other Pre-specified Outcome Measures:
Title
Quality of Life: EuroQol test
Description
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.
Time Frame
0, 6, 12 weeks
Title
Participation in Activity of Daily Living: Barthel Index
Description
Participation in Activity of Daily Living using Barthel Index Scale. Minimum Score: 0; Maximum Score: 100. Higher score means better outcomes
Time Frame
0, 6, 12 weeks
Title
Functionality: Rankin scale
Description
Functionality using Rankin Scale. Minimum Score: 0; Maximum Score: 6. Higher score means worse outcomes
Time Frame
0, 6, 12 weeks
Title
Sitting balance: Spanish versions of the Trunk Impairment Scale 2.0
Description
Sitting balance using Spanish versions of the Trunk Impairment Scale 2.0. Minimum Score: 0; Maximum Score: 26. Higher score means better outcomes
Time Frame
0, 6, 12 weeks
Title
Sitting balance: Function in Sitting Test
Description
Sitting balance using Function in Sitting Test. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes
Time Frame
0, 6, 12 weeks
Title
Standing balance: Berg Balance Scale
Description
Standing balance using Berg Balance Scale. Minimum Score: 0; Maximum Score: 56. Higher score means better outcomes
Time Frame
0, 6, 12 weeks
Title
Standing balance: Spanish version of the Postural Assessment Scale for stroke patients
Description
Standing balance using Spanish version of the Postural Assessment Scale for Stroke patients. Minimum Score: 0; Maximum Score: 36. Higher score means better outcomes
Time Frame
0, 6, 12 weeks
Title
G-Walk accelerometer system: Duration of double and individual support
Description
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.
Time Frame
0, 6, 12 weeks
Title
G-Walk accelerometer system: Duration of support and swing gait phases from right anda left lower limb
Description
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.
Time Frame
0, 6, 12 weeks
Title
G-Walk accelerometer system: Cadence of stride
Description
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.
Time Frame
0, 6, 12 weeks
Title
G-Walk accelerometer system: Gait speed
Description
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.
Time Frame
0, 6, 12 weeks
Title
G-Walk accelerometer system: Step length
Description
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.
Time Frame
0, 6, 12 weeks
Title
G-Walk accelerometer system
Description
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.
Time Frame
0, 6, 12 weeks
Title
number of falls in the last six weeks
Description
Balance. Higher scores means worse outcomes
Time Frame
0, 6, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carina F Salgueiro, MSc
Organizational Affiliation
Clínica de Neurorehabilitación
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica de neurorehabilitacion SL
City
Sant Cugat Del Valles
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is intended to share the data with other researchers such as the statistical team through encrypted e-mail.
Citations:
PubMed Identifier
23652265
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. Erratum In: Stroke. 2019 Aug;50(8):e239.
Results Reference
background
PubMed Identifier
23019591
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.
Results Reference
background
PubMed Identifier
23893833
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.
Results Reference
background
PubMed Identifier
27004638
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.
Results Reference
background
PubMed Identifier
26451007
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.
Results Reference
background
PubMed Identifier
28351168
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.
Results Reference
background
PubMed Identifier
24018373
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.
Results Reference
background
PubMed Identifier
30654899
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.
Results Reference
background
PubMed Identifier
30209991
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.
Results Reference
background
PubMed Identifier
26703120
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs