StrokeINTeRAcT-bisNCT07912320
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
A study testing Intensive rehabilitation programme in people with Stroke and Spinal Cord Injuries (SCI), run by KU Leuven at 2 sites in Belgium.
Trial summary
Rehabilitation remains important in the chronic phase after stroke or spinal cord injury, as meaningful improvements may still be achieved through intensive, goal-directed, and personalized training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Spinal Cord Injuries (SCI), Chronic Disease
- What is being tested?
- Intensive rehabilitation programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- 26 Aug 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures;
- A diagnosis of central neurological disease, made by a specialist. Conditions may include stroke or spinal cord injury:
- Stroke:
- Participants must have received a diagnosis of stroke and have been diagnosed at least 3 months ago.
- Participants who are diagnosed for the second time, but returned to normal functioning after the first stroke diagnosis (Barthel Index > 85/100), and the affected side is the same as the first stroke.
- SCI: Participants have a rating A, B, C or D on the American Spinal Injury Association (ASIA) measurement scale, which refers to patients with complete or incomplete impairment. All levels of SCI can be included, if there is a clear patient need linked to the upper and/or lower extremities.
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- At least 3 months post-discharge from hospital/rehabilitation center, living at home;
- Had a normal functional state prior to the pathology: a pre-pathology Barthel Index > 85/100;
- Unilateral or bilateral weakness of the affected upper or lower limbs (No maximum score in all affected limbs = motricity index: score 5 on 3/3 segments)
- Having the clinical opportunity to engage in exercise therapy with available technology, assessed by a specialist (under supervision of an MD);
- Age of > 18 years;
- Sufficient cognitive ability to understand the therapy exercises and give informed consent, assessed by a specialist (under supervision of an MD);
- Having participated in the first INTeRAcT study.
Who cannot join
- Having other neurological or musculoskeletal conditions that may affect the protocol, assessed by a specialist (under supervision of an MD);
- No ability to initiate movements against gravity in the upper and lower limbs;
- Severe visual impairment, communication, cognitive, and language formation problems that would prevent the intervention and measurement process, assessed by a specialist (under supervision of an MD);
- Any disorder, which in the investigator's opinion might compromise the participant's safety or compliance with the CIP;
- A female who is pregnant or breastfeeding.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Rehabilitation remains important in the chronic phase after stroke or spinal cord injury, as meaningful improvements may still be achieved through intensive, goal-directed, and personalized training. INTeRAcT-bis is a follow-up study of the original INTeRAcT program, which consisted of a 3-week intensive rehabilitation intervention (90 therapy hours) combining conventional therapy, goal-directed training, self-management, and advanced rehabilitation technologies. The study has two main objectives: (1) to evaluate the long-term clinical and health economic effects of the original INTeRAcT program, and (2) to assess the clinical effects and implementation of a second intensive rehabilitation period ("boost"). Participants receive a personalized 3-week rehabilitation program targeting upper and/or lower limb impairments based on their individual goals. In addition to clinical and health economic outcomes, the study examines participant experiences and implementation factors to support a broader implementation of intensive rehabilitation in the future.
Read the detailed description
Stroke and spinal cord injury (SCI) frequently result in long-term disability, reduced health-related quality of life, and considerable societal and economic burden. While rehabilitation efforts have historically concentrated on the acute and subacute phases, the chronic phase is increasingly recognized as a period in which clinically meaningful improvements remain possible. Emerging evidence suggests that targeted rehabilitation can improve functional outcomes even years after injury. Yet, although improvement in functional capacity remains possible in the chronic phase after SCI and stroke, standard ambulatory care may not always provide the intensity, specialization, or participation- focused approach needed to address ongoing rehabilitation needs.
The INTeRAcT project, a phase 3 randomized controlled trial, was designed to address this gap by investigating whether a high-dose, technology-integrated rehabilitation programme, delivering 90 hours of personalised motor therapy over three weeks, could improve functional independence in daily living in patients with chronic stroke and SCI, and whether this improvement would translate into health-economic benefits as compared to usual care. The trial enrolled 100 participants, and its results are promising. Specifically, although functional performance in activities of daily living (ADL) did not differ significantly between groups immediately post- intervention, the intervention group showed superior outcomes at nine months compared to usual care. Secondary outcomes relating to personalized goals and health-related quality of life improved already after three weeks and were maintained at the nine-month follow-up. Despite these encouraging clinical results, the intervention was not cost-effective at the population level within the nine-month time horizon, with intervention delivery costs being identified as the main driver of this result.
Several important questions remain unanswered. First, the durability of clinical benefits beyond the original follow-up period is unknown. Second, it remains unclear whether a second intensive rehabilitation period ("boost") can produce additional clinically meaningful improvements. Third, further research is needed to evaluate the longer-term health-economic consequences of intensive rehabilitation and to identify factors influencing future implementation in routine clinical practice.
Research questions:
- What are the long-term clinical effects of the original INTeRAcT program in patients in the chronic phase after stroke or spinal cord injury?
- What is the long-term health economic impact and cost-effectiveness of the original INTeRAcT program?
- Does a second intensive, personalized 90-hour rehabilitation program lead to additional clinically meaningful improvements?
- How is this second boost program experienced and delivered in practice, and which factors are important for its future implementation?
Study Design
INTeRAcT-bis is a longitudinal follow-up study with an embedded rehabilitation boost intervention, health-economic evaluation, and process evaluation. The study includes participants who previously participated in the original INTeRAcT trial and completed the intensive rehabilitation program. Since all eligible participants have already received the original intervention, the present study does not include randomization and uses a longitudinal within-subject design.
Participants undergo a baseline assessment (T3), conducted approximately two years after the original intervention, followed by a three-week intensive rehabilitation boost program. Clinical assessments are repeated immediately after completion of the boost intervention (T4). In parallel, health-economic data and implementation-related data are collected.
Boost rehabilitation program
The intervention consists of 90 hours of intensive rehabilitation delivered over three consecutive weeks (30 hours per week; approximately 6 hours per weekday). During these three weeks, participants will engage in intensive, individualized, and task-specific rehabilitation with a strong focus on functional goals and activities relevant to daily life. The content of the therapy was developed for the INTeRAcT intervention and is described in detail in Coremans et al., 2026. The program will include the use of advanced rehabilitation technology where appropriate and will build on the same principles as the original INTeRAcT intervention, namely high-dose, personalized rehabilitation based on the goals and needs of the participant, combined with self-management support.
- Conditions
- Stroke, Spinal Cord Injuries (SCI), Chronic Disease
- Being tested
- Intensive rehabilitation programme
- Keywords
- Stroke, personalized rehabilitation, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases, Spinal Cord Diseases, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injuries, Disease Attributes, Pathologic Processes, Pathological Conditions, Signs and Symptoms, Chronic Disease, Rehabilitation, Neurological Rehabilitation, Intensive, technology
- Medical subject headings
- Stroke, Spinal Cord Injuries, Chronic Disease, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive rehabilitation programmeOther
Intensive rehabilitation using advanced technology, based on the patient's goals.
Including cardiovascular fitness training, goal-oriented training, physiotherapy with and without advanced technology and self-management.
| Study group | Role | What they receive |
|---|---|---|
| Intensive rehabilitation program | Experimental | 3 weeks of intensive rehabilitation Receives: Other: Intensive rehabilitation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Independence Measure (FIM)
The Functional Independence Measure (FIM), which measures independence in daily functioning after stroke. The FIM consists of 18 items designed to assess to what extent a person needs assistance in performing activities of daily living safely and efficiently. The activities consist of a number of basic skills related to self-care, pelvic floor function, transfers, gait, communication and social abilities. The FIM has acceptable reliability and has been found valid in people with stroke.
Min: 13; Max: 91; Higher = better
Measured: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Change in Spinal Cord Independence Measure (SCIM)
Spinal Cord Independence Measure (SCIM), an assessment of achievements of daily function of patients with spinal cord lesions. The scale consists of 19 tasks organized in 3 subscales: self-care, respiration and sphincter management, and mobility. The SCIM is valid and reliable.
Min: 0; Max: 100; Higher = better
Measured: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Change in Goal Attainment Scaling (GAS)
Goal Attainment Scaling (GAS), is an individualised evaluation method. It is scored on an ordinal 5-point scale, which captures a person's individual treatment goal and is scored afterwards on the achievement of that treatment goal. The GAS can and will be used for both stroke and spinal cord injury.
Min: -2; Max: +2; Higher = better
Measured: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Secondary outcomes (5)
Change in The Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure (COPM), is an evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living, over time. This outcome can be used in both study populations.
Min: 1; Max: 10; Higher = better
Measured: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Change in EQ-5D-5L
EQ-5D-5L, measures quality of life at five levels of health (mobility, self-care, daily activities, pain/discomfort and anxiety/depression). From this, a weighted health index can be calculated for an individual or population. This scale can also be used for both populations.
Min: 1; Max: 100; Higher = better
Measured: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Change in General Self-Efficacy Scale (GSES)
Assesses one's overall confidence in one's own ability to cope with stressful or challenging situations.
Min: 10; Max: 40; Higher = better
Measured: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Change in Function In Sitting Test (FIST)
Evaluation of sitting balance that evaluates sensory, motor, proactive, reactive, and steady state balance factors.
Min: 0; Max: 54; Higher = better
Measured: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Change in strength (Handheld dynamometer key movements)
Muscle strength is measured using a handheld dynamometer for the following movements:
- Shoulder flexion
- Elbow extension
- Wrist dorsiflexion
- Knee extension
- Ankle dorsiflexion
Measured: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start26 Aug 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (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 StrokeStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal follow-up study with an embedded boost intervention and health economic and process evaluation
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, AZ Herentals, To Walk Again REVAlution Center
- Responsible party
- Principal investigator, Prof Geert Verheyden, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912320
- Sponsor's protocol ID
- 3M260001
- Acronym
- INTeRAcT-bis
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coremans M, Allewijn I, Bataillie F, De Bruyn L, Fobelets M, Jacobs F, Janssens S, Pattyn L, Putman K, Schiltz A, Tedesco Triccas L, Van Thienen F, Verheyden G. Impact of a Personalized, High-Dose, Intensive Motor Rehabilitation Program, Integrating Advanced Technology for Adults With Central Neurological Conditions (INTeRAcT): Protocol for a Single-Blind Randomized Controlled Trial With a Clinical, Health Economic, and Process Evaluation. JMIR Res Protoc. 2026 May 4;15:e93234. doi: 10.2196/93234.
PubMed 42095779
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
- ClinicalTrials.gov ID
- NCT07912320
- Acronym / sponsor ID
- INTeRAcT-bis / 3M260001
- Conditions
- Stroke, Spinal Cord Injuries (SCI), Chronic Disease
- Keywords
- Stroke, personalized rehabilitation, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, AZ Herentals, To Walk Again REVAlution Center
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 3 Nov 2026 (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.
Rehabilitation remains important in the chronic phase after stroke or spinal cord injury, as meaningful improvements may still be achieved through intensive, goal-directed, and personalized training. INTeRAcT-bis is a follow-up study of the original INTeRAcT program, which consisted of a 3-week intensive rehabilitation intervention (90 therapy hours) combining conventional therapy, goal-directed training, self-management, and advanced rehabilitation technologies. The study has two main objectives: (1) to evaluate the long-term clinical and health economic effects of the original INTeRAcT program, and (2) to assess the clinical effects and implementation of a second intensive rehabilitation period ("boost"). Participants receive a personalized 3-week rehabilitation program targeting upper and/or lower limb impairments based on their individual goals. In addition to clinical and health economic outcomes, the study examines participant experiences and implementation factors to support a broader implementation of intensive rehabilitation in the future.
Detailed description
Stroke and spinal cord injury (SCI) frequently result in long-term disability, reduced health-related quality of life, and considerable societal and economic burden. While rehabilitation efforts have historically concentrated on the acute and subacute phases, the chronic phase is increasingly recognized as a period in which clinically meaningful improvements remain possible. Emerging evidence suggests that targeted rehabilitation can improve functional outcomes even years after injury. Yet, although improvement in functional capacity remains possible in the chronic phase after SCI and stroke, standard ambulatory care may not always provide the intensity, specialization, or participation- focused approach needed to address ongoing rehabilitation needs.
The INTeRAcT project, a phase 3 randomized controlled trial, was designed to address this gap by investigating whether a high-dose, technology-integrated rehabilitation programme, delivering 90 hours of personalised motor therapy over three weeks, could improve functional independence in daily living in patients with chronic stroke and SCI, and whether this improvement would translate into health-economic benefits as compared to usual care. The trial enrolled 100 participants, and its results are promising. Specifically, although functional performance in activities of daily living (ADL) did not differ significantly between groups immediately post- intervention, the intervention group showed superior outcomes at nine months compared to usual care. Secondary outcomes relating to personalized goals and health-related quality of life improved already after three weeks and were maintained at the nine-month follow-up. Despite these encouraging clinical results, the intervention was not cost-effective at the population level within the nine-month time horizon, with intervention delivery costs being identified as the main driver of this result.
Several important questions remain unanswered. First, the durability of clinical benefits beyond the original follow-up period is unknown. Second, it remains unclear whether a second intensive rehabilitation period ("boost") can produce additional clinically meaningful improvements. Third, further research is needed to evaluate the longer-term health-economic consequences of intensive rehabilitation and to identify factors influencing future implementation in routine clinical practice.
Research questions:
- What are the long-term clinical effects of the original INTeRAcT program in patients in the chronic phase after stroke or spinal cord injury?
- What is the long-term health economic impact and cost-effectiveness of the original INTeRAcT program?
- Does a second intensive, personalized 90-hour rehabilitation program lead to additional clinically meaningful improvements?
- How is this second boost program experienced and delivered in practice, and which factors are important for its future implementation?
Study Design
INTeRAcT-bis is a longitudinal follow-up study with an embedded rehabilitation boost intervention, health-economic evaluation, and process evaluation. The study includes participants who previously participated in the original INTeRAcT trial and completed the intensive rehabilitation program. Since all eligible participants have already received the original intervention, the present study does not include randomization and uses a longitudinal within-subject design.
Participants undergo a baseline assessment (T3), conducted approximately two years after the original intervention, followed by a three-week intensive rehabilitation boost program. Clinical assessments are repeated immediately after completion of the boost intervention (T4). In parallel, health-economic data and implementation-related data are collected.
Boost rehabilitation program
The intervention consists of 90 hours of intensive rehabilitation delivered over three consecutive weeks (30 hours per week; approximately 6 hours per weekday). During these three weeks, participants will engage in intensive, individualized, and task-specific rehabilitation with a strong focus on functional goals and activities relevant to daily life. The content of the therapy was developed for the INTeRAcT intervention and is described in detail in Coremans et al., 2026. The program will include the use of advanced rehabilitation technology where appropriate and will build on the same principles as the original INTeRAcT intervention, namely high-dose, personalized rehabilitation based on the goals and needs of the participant, combined with self-management support.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal follow-up study with an embedded boost intervention and health economic and process evaluation
| Arm | Type | Receives |
|---|---|---|
| Intensive rehabilitation program | Experimental | Other: Intensive rehabilitation programme3 weeks of intensive rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures;
- A diagnosis of central neurological disease, made by a specialist. Conditions may include stroke or spinal cord injury:
- At least 3 months post-discharge from hospital/rehabilitation center, living at home;
- Had a normal functional state prior to the pathology: a pre-pathology Barthel Index > 85/100;
- Unilateral or bilateral weakness of the affected upper or lower limbs (No maximum score in all affected limbs = motricity index: score 5 on 3/3 segments)
Key exclusion criteria (5 listed)
- Having other neurological or musculoskeletal conditions that may affect the protocol, assessed by a specialist (under supervision of an MD);
- No ability to initiate movements against gravity in the upper and lower limbs;
- Severe visual impairment, communication, cognitive, and language formation problems that would prevent the intervention and measurement process, assessed by a specialist (under supervision of an MD);
- Any disorder, which in the investigator's opinion might compromise the participant's safety or compliance with the CIP;
- A female who is pregnant or breastfeeding.
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 |
|---|---|---|
| Intensive rehabilitation programmeIntensive rehabilitation using advanced technology, based on the patient's goals. Including cardiovascular fitness training, goal-oriented training, physiotherapy with and without advanced technology and self-management. | Other | Intensive rehabilitation program |
Primary outcome
Change in Functional Independence Measure (FIM)
Time frame: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
The Functional Independence Measure (FIM), which measures independence in daily functioning after stroke. The FIM consists of 18 items designed to assess to what extent a person needs assistance in performing activities of daily living safely and efficiently. The activities consist of a number of basic skills related to self-care, pelvic floor function, transfers, gait, communication and social abilities. The FIM has acceptable reliability and has been found valid in people with stroke. Min: 13; Max: 91; Higher = better
Change in Spinal Cord Independence Measure (SCIM)
Time frame: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Spinal Cord Independence Measure (SCIM), an assessment of achievements of daily function of patients with spinal cord lesions. The scale consists of 19 tasks organized in 3 subscales: self-care, respiration and sphincter management, and mobility. The SCIM is valid and reliable. Min: 0; Max: 100; Higher = better
Change in Goal Attainment Scaling (GAS)
Time frame: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Goal Attainment Scaling (GAS), is an individualised evaluation method. It is scored on an ordinal 5-point scale, which captures a person's individual treatment goal and is scored afterwards on the achievement of that treatment goal. The GAS can and will be used for both stroke and spinal cord injury. Min: -2; Max: +2; Higher = better
5 secondary outcomes
Change in The Canadian Occupational Performance Measure (COPM)
Time frame: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Change in EQ-5D-5L
Time frame: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Change in General Self-Efficacy Scale (GSES)
Time frame: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Change in Function In Sitting Test (FIST)
Time frame: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Change in strength (Handheld dynamometer key movements)
Time frame: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 42095779Coremans M, Allewijn I, Bataillie F, De Bruyn L, Fobelets M, Jacobs F, Janssens S, Pattyn L, Putman K, Schiltz A, Tedesco Triccas L, Van Thienen F, Verheyden G. Impact of a Personalized, High-Dose, Intensive Motor Rehabilitation Program, Integrating Advanced Technology for Adults With Central Neurological Conditions (INTeRAcT): Protocol for a Single-Blind Randomized Controlled Trial With a Clinical, Health Economic, and Process Evaluation. JMIR Res Protoc. 2026 May 4;15:e93234. doi: 10.2196/93234.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive rehabilitation programme in people with Stroke and Spinal Cord Injuries (SCI), run by KU Leuven at 2 sites 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 13 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Independence Measure (FIM) (time frame: Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).). The study lists 3 primary outcomes in all. 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 NCT07912320, 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 3 Nov 2026.