Rehabilitation monitoring device to improve quality of life in stroke patients

Completed

• Conditions: Post-stroke subjects; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN71683182
• Lead Sponsor: nidad de Conocimiento y Evidencia, Universidad Peruana Cayetano Heredia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-03
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life, evaluated with the Short Form-36 (SF-36) immediately after enrollment and at 30 days

Secondary Outcome Measures

Name	Time	Method
1. Depression, evaluated using the PHQ-9 immediately after enrollment and at 30 days<br>2. Functionality, evaluated through the Barthel Index immediately after enrollment and at 30 days<br>3. Upper limb motor function, assessed through the Wolf Motor Function Test immediately after enrollment and at 30 days<br>4. Dependency, evaluated using the Katz Index immediately after enrollment and at 30 days<br><br>Intervention group only:<br>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<br>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<br>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<br>