Online occupational therapy to help stroke survivors improve everyday activities
| ISRCTN | ISRCTN11508911 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11508911 |
| Sponsor | Cyprus University of Technology |
| Funder | Investigator initiated and funded |
- Submission date
- 25/02/2026
- Registration date
- 25/02/2026
- Last edited
- 24/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Many people experience ongoing difficulties with everyday activities after stroke. This study aims to examine whether an online occupational therapy program for Greek-speaking individuals with chronic stroke is feasible and acceptable and to explore its potential effects on daily activities.
Who can participate?
Adults aged 18 years or older who had a stroke more than 6 months ago, speak Greek, and have access to the internet can take part.
What does the study involve?
Participants are randomly allocated to receive an online occupational therapy program or to a waitlist group. The program is delivered online over approximately 10 weeks. Assessments are completed online at the start, after the intervention period, and one month later.
What are the possible benefits and risks of participating?
Participants may experience improvements in everyday activities. No serious risks are expected. Participation may involve mild fatigue or inconvenience related to online sessions.
Where is the study run from?
Cyprus University of Technology
When is the study starting, and how long is it expected to run for?
February 2025 to July 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Nefeli Efstathia Papasalourou, np.papasalourou@edu.cut.ac.cy
Contact information
Public, Scientific, Principal investigator
30 Arch. Kyprianos Str.
Limassol
3036
Cyprus
 ORCID ID |
0009-0004-6059-5023 |
|---|---|
| Phone | +30 (0)6977202259 |
| np.papasalourou@edu.cut.ac.cy |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Uncontrolled |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | A pilot randomized waitlist-controlled trial comparing tele-CO-OP with a waitlist control to assess feasibility, acceptability, and preliminary efficacy in Greek-speaking individuals with chronic stroke |
| Study acronym | Tele-CO-OP Pilot RCT |
| Study objectives | |
| Ethics approval(s) |
Approved 07/10/2024, Cyprus National Bioethics Committee (Ploutonos & 22 Laertou Str., Nicosia, 2365, Cyprus; +357 (0)22819101 / 22819122 / 22-809039 / 22-809038; cnbc@bioethics.gov.cy), ref: ЕЕВК/ЕП /2024/59 |
| Health condition(s) or problem(s) studied | Chronic stroke |
| Intervention | Method of randomisation Participants are randomly allocated to the intervention or waitlist control group using a computer-generated stratified randomization scheme with a 1:1 allocation ratio. Randomization is conducted by an independent statistician, with stratification by age (≤55 years, >55 years) and location (Cyprus, Greece). Allocation concealment is ensured using sealed opaque envelopes that are opened only after completion of baseline assessments. Intervention group: Participants receive tele-delivered Cognitive Orientation to daily Occupational Performance (tele-CO-OP), consisting of 16 individual sessions (up to 1 hour each) delivered over a maximum period of 10 weeks (1–2 sessions per week) by a trained occupational therapist via videoconferencing. Control group: Participants allocated to the waitlist control group receive no active rehabilitation for 10 weeks and are subsequently offered the tele-CO-OP intervention if they wish. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 27/07/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 18 |
| Total final enrolment | 18 |
| Key inclusion criteria | 1. Adults aged ≥18 years with ischemic or hemorrhagic stroke ≥6 months post-stroke 2. Greek-speaking (native or fluent) 3. Ability to self-identify 5 specific areas of everyday life difficulties 4. Access to internet-enabled device suitable for videoconferencing 5. Ability to provide informed consent |
| Key exclusion criteria | 1. Other neurological or severe psychiatric conditions that required hospitalization 2. Dementia diagnosis or cognitive impairment (≤21 on the Montreal Cognitive Assessment [MoCA]) 3. Severe aphasia (the “Cookie Theft” picture from the Boston Diagnostic Aphasia Examination [BDAE]) 4. Concurrent participation in other occupational therapy |
| Date of first enrolment | 17/02/2025 |
| Date of final enrolment | 19/05/2026 |
Locations
Countries of recruitment
- Cyprus
- Greece
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
24/08/2026: The following changes were made to the study record:
1. The date of final enrolment was changed from 31/05/2026 to 19/05/2026.
2. The completion date was changed from 31/08/2026 to 27/07/2026.
3. Final enrolment number added.
25/02/2026: Study's existence confirmed by the Cyprus National Bioethics Committee.
