Rehabilitation monitoring device to improve quality of life in stroke patients

Use of a rehabilitation monitoring device to improve quality of life in patients with recent stroke: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71683182

Enrollment

Registered

2017-07-03

Start date

2017-06-29

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke subjects Circulatory System Stroke, not specified as haemorrhage or infarction

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Peru

Contacts

Public ContactAlvaro Taype-Rondan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026