Brain Injury, VascularTELERENCT06016374
Development and Validation of a Structured Tele-rehabilitation Programme of Brain Injured Patients
A study testing telerehabilitation in people with Brain Injury, Vascular and Hemorrhagic Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The goal of this research project is to develop a tele-rehabilitation programme, which will constitute an original care pathway for brain damaged patients. It will aim to improve their impairments, activities and social participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Vascular, Hemorrhagic Stroke, Ischemic Stroke
- What is being tested?
- telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present with an acute, subacute or chronic ischemic or hemorrhagic stroke,
- Be at least 18 years old,
- To be hospitalised in the neurorehabilitation unit.
Who cannot join
- Other neurological or musculoskeletal disease limiting their functional capacities,
- Pain in the upper limb making it impossible to mobilise.
- Inadaptability of the device to the patient's physiological position, especially in cases of contracture or severe spasticity.
- Severe cognitive disorders preventing the understanding of instructions.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Clinique Universitaires Saint-Luc
Brussels, Woluwé-Saint-Lambert, 1200
Thierry Lejeune, MD, PhD, +3227641648, thierry.lejeune@saintluc.uclouvain.be
Mathilde Van Durme, +3227641675, mathilde.vandurme@saintluc.uclouvain.be
About this study
Official title: Development and Validation of a Structured Tele-rehabilitation Programme to Improve the Treatment of Brain Injured Patients
The goal of this research project is to develop a tele-rehabilitation programme, which will constitute an original care pathway for brain damaged patients. It will aim to improve their impairments, activities and social participation. The programme will deliver a therapeutic education and self-education programme targeting the upper and lower limbs, and will assess the patients by means of a diary and self-evaluation questionnaires.
Read the detailed description
According to WHO (1997), telemedicine is defined as "the part of medicine that uses the transmission of medical information (images, reports, recordings, etc.) by telecommunication, with a view to obtaining at a distance a diagnosis, a specialised opinioń, continuous monitoring of a patient, a therapeutic decision". More specifically, tele-rehabilitation is defined as "a set of interventions carried out at a distance and using communication technologies and information services, with the aim of improving the health or well-being of the persons involved". In other words, tele-rehabilitation is a form of health care practice that uses information and communication technologies to exchange information between rehabilitation providers and patients.
Tele-rehabilitation programmes typically include self-rehabilitation. Self-rehabilitation consists of a personalised therapeutic programme during which the patient performs rehabilitation exercises independently. The patient is supervised by a clinician (e.g. physiotherapist or occupational therapist) throughout the programme. Initially to explain the programme and teach the patient how to use the technology. Then, to coach them regularly. Tele-rehabilitation programmes can be delivered in hospitals, rehabilitation centres or at home.
Stroke affects 19,000 people per year in Belgium and is the leading cause of acquired disability in adults in industrialised countries. After a stroke, patients recover some of their functional abilities through spontaneous recovery. Rehabilitation improves this functional recovery, in terms of impairments, but especially in terms of activities and social participation, according to the International Classification of Functioning, Disability and Health. This rehabilitation must be intense, early and interdisciplinary, to promote cerebral neuroplasticity. However, more than half of these patients retain sequelae in terms of locomotion or function of the paretic upper limb.
Current literature indicates that functional rehabilitation after stroke can be further optimised. On the one hand, current recommendations show that rehabilitation should be intensive and task-oriented to promote brain neuroplasticity and motor relearning. Currently, the intensity of treatment is generally insufficient in both the acute and chronic phases and may vary depending on the management setting. In Belgium, patients typically receive 2 hours of rehabilitation per working day in the acute and subacute phasë, and 30 minutes in the chronic phase. These patients are therefore globally not active enough.
On the other hand, complementary treatments to classical rehabilitation have shown their effectiveness in recent years. Thus, several scientific publications have shown that tele-rehabilitation, which mainly includes remotely supervised self-rehabilitation programmes, is effective in improving impairments and activities in people who have had a stroke, either as a complement or a substitute for conventional rehabilitation. In 2018, Tchéro et al. showed that tele-rehabilitation was comparable in effectiveness to conventional treatments. A recent Cochrane review also showed that tele-rehabilitation was as effective as standard care, with a low to moderate level of evidence, on independence in daily activities, balance or quality of life. In addition to being able to intensify treatment, tele-rehabilitation is inexpensive and can also facilitate access to care for patients who do not have a physiotherapy practice or rehabilitation centre in their immediate vicinity.
A structured telemedicine programme for stroke rehabilitation should include different elements.
- Therapeutic education: Texts or videos that allow the patient and his or her relatives to better understand the condition and to know what they can do to improve it, for example, in terms of lifestyle, secondary prevention or rehabilitation.
- Self-education exercise programmes: physical exercises adapted to the patient's health problem are presented in the form of commented videos.
- Assessment: patients' functional abilities are assessed using PROMS-type questionnaires.
- A space for instant communication between the patient and the rehabilitation team.
This programme should be configured, personalised and regularly updated for each patient by a health professional.
Telemedicine has recently been developed in Belgium in the context of the COVID19 crisis. It has made it possible to ensure the continuity of rehabilitation care. Different technical solutions are available to implement telemedicine. They must comply with different regulations to ensure the security and confidentiality of health data.
A new tele-rehabilitation programme for post-stroke patients could meet the clinical needs to intensify treatment and improve accessibility to health care. Over the past few months, our team has been developing a tele-rehabilitation programme for stroke patients. This programme, called TeleRe, is a novel care pathway for stroke patients. It will aim to improve their impairments, activities and social participation, and ultimately their quality of life.
After a stroke, neurorehabilitation varies from one patient to another, and over time for the same patient. The rehabilitation plan is established for each patient, with his or her agreement, at the beginning of his or her treatment and then regularly updated. Typically, the personalised treatment plan includes physiotherapy, occupational therapy, speech therapy and neuropsychology. Our TeleRé programme would be in addition to these standard treatments.
- Conditions
- Brain Injury, Vascular, Hemorrhagic Stroke, Ischemic Stroke
- Being tested
- telerehabilitation
- Medical subject headings
- Cerebrovascular Trauma, Hemorrhagic Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telerehabilitationOther
During this study, the patient will be asked to use the "TeleRé" programme at least 5 times a week for 30 minutes for one month. Through the programme, they will have access to exercises in video format and thus self-rehabilitation as well as serious therapeutic games. The self-education games and videos target the functional and motor recovery of the upper limb. In addition, cognitive functions (attention, memory, etc.) will also be stimulated via the programme. Therapeutic education modules and PROMS assessments will also be available.
| Study group | Role | What they receive |
|---|---|---|
| telerehabilitation for post stroke patient | Experimental | During the study, the patient will be asked to use the TeleRé programme on the devices on a regular, daily basis, either in a hospital room or at home. They will also be asked to evaluate the programme via various questionnaires and assessments. Receives: Other: telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
usability
At the end of the trial, subjects will complete the System Usability Scale (SUS), a ten-item questionnaire evaluated on a Likert scale. This questionnaire is used to assess the usability of the TéléRé program.
The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.
Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking.
It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Measured: The test will be administered only once at the end of the intervention. So, 4 weeks after the start of the experiment, during the last session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start21 Feb 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Injury, VascularStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Lejeune, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016374
- Sponsor's protocol ID
- 2022 474
- Acronym
- TELERE
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Durme M, Lejeune T, Stoquart G, Dehem S. Developing an mHealth App-based Telerehabilitation Programme for Stroke Survivors: A Feasibility and Usability Study. NeuroRehabilitation. 2025 Aug;57(1):103-110. doi: 10.1177/10538135251344925. Epub 2025 May 28.
PubMed 40432510
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Structured Tele-rehabilitation Programme to Improve the Treatment of Brain Injured Patients
- ClinicalTrials.gov ID
- NCT06016374
- Acronym / sponsor ID
- TELERE / 2022 474
- Conditions
- Brain Injury, Vascular, Hemorrhagic Stroke, Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research project is to develop a tele-rehabilitation programme, which will constitute an original care pathway for brain damaged patients. It will aim to improve their impairments, activities and social participation. The programme will deliver a therapeutic education and self-education programme targeting the upper and lower limbs, and will assess the patients by means of a diary and self-evaluation questionnaires.
Detailed description
According to WHO (1997), telemedicine is defined as "the part of medicine that uses the transmission of medical information (images, reports, recordings, etc.) by telecommunication, with a view to obtaining at a distance a diagnosis, a specialised opinioń, continuous monitoring of a patient, a therapeutic decision". More specifically, tele-rehabilitation is defined as "a set of interventions carried out at a distance and using communication technologies and information services, with the aim of improving the health or well-being of the persons involved". In other words, tele-rehabilitation is a form of health care practice that uses information and communication technologies to exchange information between rehabilitation providers and patients.
Tele-rehabilitation programmes typically include self-rehabilitation. Self-rehabilitation consists of a personalised therapeutic programme during which the patient performs rehabilitation exercises independently. The patient is supervised by a clinician (e.g. physiotherapist or occupational therapist) throughout the programme. Initially to explain the programme and teach the patient how to use the technology. Then, to coach them regularly. Tele-rehabilitation programmes can be delivered in hospitals, rehabilitation centres or at home.
Stroke affects 19,000 people per year in Belgium and is the leading cause of acquired disability in adults in industrialised countries. After a stroke, patients recover some of their functional abilities through spontaneous recovery. Rehabilitation improves this functional recovery, in terms of impairments, but especially in terms of activities and social participation, according to the International Classification of Functioning, Disability and Health. This rehabilitation must be intense, early and interdisciplinary, to promote cerebral neuroplasticity. However, more than half of these patients retain sequelae in terms of locomotion or function of the paretic upper limb.
Current literature indicates that functional rehabilitation after stroke can be further optimised. On the one hand, current recommendations show that rehabilitation should be intensive and task-oriented to promote brain neuroplasticity and motor relearning. Currently, the intensity of treatment is generally insufficient in both the acute and chronic phases and may vary depending on the management setting. In Belgium, patients typically receive 2 hours of rehabilitation per working day in the acute and subacute phasë, and 30 minutes in the chronic phase. These patients are therefore globally not active enough.
On the other hand, complementary treatments to classical rehabilitation have shown their effectiveness in recent years. Thus, several scientific publications have shown that tele-rehabilitation, which mainly includes remotely supervised self-rehabilitation programmes, is effective in improving impairments and activities in people who have had a stroke, either as a complement or a substitute for conventional rehabilitation. In 2018, Tchéro et al. showed that tele-rehabilitation was comparable in effectiveness to conventional treatments. A recent Cochrane review also showed that tele-rehabilitation was as effective as standard care, with a low to moderate level of evidence, on independence in daily activities, balance or quality of life. In addition to being able to intensify treatment, tele-rehabilitation is inexpensive and can also facilitate access to care for patients who do not have a physiotherapy practice or rehabilitation centre in their immediate vicinity.
A structured telemedicine programme for stroke rehabilitation should include different elements.
- Therapeutic education: Texts or videos that allow the patient and his or her relatives to better understand the condition and to know what they can do to improve it, for example, in terms of lifestyle, secondary prevention or rehabilitation.
- Self-education exercise programmes: physical exercises adapted to the patient's health problem are presented in the form of commented videos.
- Assessment: patients' functional abilities are assessed using PROMS-type questionnaires.
- A space for instant communication between the patient and the rehabilitation team.
This programme should be configured, personalised and regularly updated for each patient by a health professional.
Telemedicine has recently been developed in Belgium in the context of the COVID19 crisis. It has made it possible to ensure the continuity of rehabilitation care. Different technical solutions are available to implement telemedicine. They must comply with different regulations to ensure the security and confidentiality of health data.
A new tele-rehabilitation programme for post-stroke patients could meet the clinical needs to intensify treatment and improve accessibility to health care. Over the past few months, our team has been developing a tele-rehabilitation programme for stroke patients. This programme, called TeleRe, is a novel care pathway for stroke patients. It will aim to improve their impairments, activities and social participation, and ultimately their quality of life.
After a stroke, neurorehabilitation varies from one patient to another, and over time for the same patient. The rehabilitation plan is established for each patient, with his or her agreement, at the beginning of his or her treatment and then regularly updated. Typically, the personalised treatment plan includes physiotherapy, occupational therapy, speech therapy and neuropsychology. Our TeleRé programme would be in addition to these standard treatments.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| telerehabilitation for post stroke patient | Experimental | Other: telerehabilitationDuring the study, the patient will be asked to use the TeleRé programme on the devices on a regular, daily basis, either in a hospital room or at home. They will also be asked to evaluate the programme via various questionnaires and assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Present with an acute, subacute or chronic ischemic or hemorrhagic stroke,
- Be at least 18 years old,
- To be hospitalised in the neurorehabilitation unit.
Key exclusion criteria (4 listed)
- Other neurological or musculoskeletal disease limiting their functional capacities,
- Pain in the upper limb making it impossible to mobilise.
- Inadaptability of the device to the patient's physiological position, especially in cases of contracture or severe spasticity.
- Severe cognitive disorders preventing the understanding of instructions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telerehabilitationDuring this study, the patient will be asked to use the "TeleRé" programme at least 5 times a week for 30 minutes for one month. Through the programme, they will have access to exercises in video format and thus self-rehabilitation as well as serious therapeutic games. The self-education games and videos target the functional and motor recovery of the upper limb. In addition, cognitive functions (attention, memory, etc.) will also be stimulated via the programme. Therapeutic education modules and PROMS assessments will also be available. | Other | telerehabilitation for post stroke patient |
Primary outcome
usability
Time frame: The test will be administered only once at the end of the intervention. So, 4 weeks after the start of the experiment, during the last session.
At the end of the trial, subjects will complete the System Usability Scale (SUS), a ten-item questionnaire evaluated on a Likert scale. This questionnaire is used to assess the usability of the TéléRé program. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 40432510Van Durme M, Lejeune T, Stoquart G, Dehem S. Developing an mHealth App-based Telerehabilitation Programme for Stroke Survivors: A Feasibility and Usability Study. NeuroRehabilitation. 2025 Aug;57(1):103-110. doi: 10.1177/10538135251344925. Epub 2025 May 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Lejeune, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telerehabilitation in people with Brain Injury, Vascular and Hemorrhagic Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thierry Lejeune, MD, PhD (+3227641648, thierry.lejeune@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
usability (time frame: The test will be administered only once at the end of the intervention. So, 4 weeks after the start of the experiment, during the last session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06016374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.