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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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21 August 2017 |
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Main ID: |
ISRCTN71683182 |
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Date of registration:
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03/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rehabilitation monitoring device to improve quality of life in stroke patients
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Scientific title:
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Use of a rehabilitation monitoring device to improve quality of life in patients with recent stroke: a randomised controlled trial |
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Date of first enrolment:
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29/06/2017 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN71683182 |
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Study type:
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Interventional |
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Study design:
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Evaluator-blinded 1-month randomised pilot clinical trial with two parallel groups and a 1:1 allocation (Quality of life)
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Phase:
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Countries of recruitment
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Peru
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Alvaro
Taype-Rondan |
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Address:
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Avenida Armendáriz 497
Miraflores
51
Lima
Peru |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients:
1. Have suffered an ischemic stroke at least 6 months ago/in the last 6 months, according to their clinical record
2. Be over 18 years of age
3. Dependency level from A to D according to the Katz Index
4. Have verbal permission from their rehabilitation physician to use the device
5. Have access to an Android phone during their rehabilitation
6. Have a caregiver or a person responsible for attending their basic care
7. Give written informed consent to participate in the study
Caregivers:
1. Be responsible for assisting the post-stroke patient
2. Be over 18 years of age
3. Give written informed consent to participate in the study
4. Be able to use mobile phone applications and understand instructions
5. Do not have/suffer from moderate or severe cognitive, visual or auditory impairment
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Post-stroke subjects
Circulatory System
Stroke, not specified as haemorrhage or infarction
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Intervention(s)
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Simple randomization will be performed using the tool in http://www.randomization.com/. Subjects will be randomized to one of the two arms (control or intervention) via opaque, sealed envelopes, each bearing on the outside only the code (from 1 to 20).
Both groups receive the usual care rehabilitation two or three times a week. The intervention group also receive the HealthRecover device, which is a non-invasive device that consists of two straps that fit around the arm and the wrist, along with a mobile phone application. This device monitors the home rehabilitation exercises that the therapist has assigned to each patient (the therapist is able to assign a series of exercise routines ). This device collects information from the movement of the participant and the app counts the number of repetitions performed in each rehabilitation exercise, and evaluates how well these exercises have been performed.
An evaluation to collect data on adequate use, frequency of use, and usability, is performed at three time points: immediately after enrollment, at 15 days after enrolling the patient in the study, and at 30 days after the patient has been enrolled in the study. Additionally, an evaluation is carried out in order to collect data on quality of life, depression, functionality, upper limb motor function, and dependency. This is performed immediately after enrollment and at 30 days after enrolling the patient to study.
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Primary Outcome(s)
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Quality of life, evaluated with the Short Form-36 (SF-36) immediately after enrollment and at 30 days
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Secondary Outcome(s)
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1. Depression, evaluated using the PHQ-9 immediately after enrollment and at 30 days
2. Functionality, evaluated through the Barthel Index immediately after enrollment and at 30 days
3. Upper limb motor function, assessed through the Wolf Motor Function Test immediately after enrollment and at 30 days
4. Dependency, evaluated using the Katz Index immediately after enrollment and at 30 days
Intervention group only:
1. Adequate use: patients’ use of the device, evaluated with direct observation and a checklist immediately after enrollment, at 15 days and at 30 days
2. Usability: defined as the opinion of the participant regarding the use (usefulness?) of the device immediately after enrollment, at 15 days and at 30 days
3. Frequency of use: number of times the participants used the device, as registered in the device software immediately after enrollment, at 15 days and at 30 days
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Secondary ID(s)
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HealthRecover
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Source(s) of Monetary Support
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CONCYTEC: Fondo Nacional de Desarrollo Científico y Tecnológico, Fondecyt (Project number: 259-2015).
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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