NCT03507894

Brief Summary

The aim of this study is to determine the impact of an m-health based intervention on long term adherence to a rehabilitation program for stroke survivors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

April 16, 2018

Last Update Submit

August 30, 2023

Conditions

Keywords

rehabilitationexercisestrokeadherence

Outcome Measures

Primary Outcomes (1)

  • Adherence

    Adherence will be monitored with an app that will record activity time (walking time and distance)

    8 weeks

Secondary Outcomes (1)

  • Gait speed

    8 weeks

Study Arms (1)

m-health stroke rehabilitation

8-week multimodal exercise rehabilitation program (MERP) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology

Behavioral: Multimodal Exercise Rehabilitation Program

Interventions

Rehabilitation program based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology

m-health stroke rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be stroke survivors who have completed a conventional rehabilitation program. They will be recruited from Hospital-Consorci Sanitari de Terrassa (Barcelona, Spain) over a period of six months.

You may qualify if:

  • Diagnosis of ischemic or hemorrhagic stroke
  • age ≥18;
  • Functional Ambulation Classification (FAC) ≥3
  • Barthel Index ≥45

You may not qualify if:

  • Cognitive impairment (Mini Mental State Examination ≤24)
  • Unstable cardiovascular disease (acute heart failure, recent myocardial infarction, unstable angina and uncontrolled arrhythmias)
  • Alcohol or other toxic substances abuse
  • Decompensated psychiatric disorders that prevented from following a group session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08232, Spain

Location

Related Publications (1)

  • Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Montserrat Grau-Pellicer, PhD

    Consorci Sanitari de Terrassa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 25, 2018

Study Start

April 3, 2018

Primary Completion

December 28, 2018

Study Completion

January 31, 2019

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations