An interventional study of Intensive rehabilitation programme in Stroke, Spinal Cord Injuries (SCI) and Chronic Disease, sponsored by KU Leuven. Enrolling by invitation at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by KU Leuven · Not applicable, Interventional, and Treatment
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.
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:
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.
7,476 studies on the registry are indexed under Stroke; 2,024 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 5,506 interventional studies indexed under Stroke.
Browse Stroke studies →KU Leuven is the lead sponsor of 373 studies on the registry; 65 are open to participants now.
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A diagnosis of central neurological disease, made by a specialist. Conditions may include stroke or spinal cord injury:
Stroke:
Exclusion Criteria:
3 weeks of intensive rehabilitation
Other: Intensive rehabilitation programme
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.
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
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 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
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 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
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 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
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
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
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)
Assesses one's overall confidence in one's own ability to cope with stressful or challenging situations. Min: 10; Max: 40; Higher = better
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)
Evaluation of sitting balance that evaluates sensory, motor, proactive, reactive, and steady state balance factors. Min: 0; Max: 54; Higher = better
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)
Muscle strength is measured using a handheld dynamometer for the following movements: * Shoulder flexion * Elbow extension * Wrist dorsiflexion * Knee extension * Ankle dorsiflexion
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).
Determinants of therapy success
An exploratory analysis will be conducted to investigate determinants of therapy success. Candidate predictors include age, disease severity, cognition (measured using the Oxford Cognitive Screen (OCS) and the Edinburgh Cognitive and Behavioural ALS Screen (ECAS), for the stroke and SCI population, respectively), motivation (measured using the Intrinsic Motivation Inventory (IMI) \& VAS-scale per goal), disease insight (Self-Awareness in Daily Life; SADL-3), and self-efficacy (General self-efficacy questionnaire).
Time frame: Long-term follow-up / pre-boost assessment (+/- 3 years after the original INTeRAcT intervention): OCS, ECAS, VAS scales, SADL and General self-efficacy questionnaire Post-boost assessment: Intrinsic Motivation Inventory (IMI)
Health economic evaluation
Health economic data are collected to estimate direct medical, direct non-medical, and indirect costs associated with participants' condition during the period between completion of the original INTeRAcT study and the start of INTeRAcT-bis. The following types of resource use will be assessed: healthcare utilisation (including emergency visits, hospitalisations, outpatient care, medication use, and rehabilitation-related care), transport costs, home care support, use of assistive devices, informal care, productivity losses (e.g., days away from work), and other relevant health-related events.
Time frame: Long-term follow-up, approximately 3 years after completion of the original INTeRAcT intervention
Process evaluation
Structured therapy diaries will document how the intervention is delivered, including session duration and the content of the of exercises. Semi-structured interviews with participants, therapists, hospital management, and other relevant stakeholders will explore the feasibility, acceptability, perceived benefits, barriers and facilitators to implementation, and opportunities for future implementation of the programme. Observations will deepen understanding of content and delivery: 14 participants will be observed during sessions using a structured scheme. Each therapy type (upper/lower limb, with/without technology, cardiovascular fitness, goal-oriented training, self-management) will be observed weekly over 3 weeks, totalling 6-7 hours per participant per week. Observations will help interpret outcome variations across settings. This outcome represents a mixed-methods process evaluation. The above mentioned complementary sources will be triangulated.
Time frame: Structured therapy diaries: during intervention; Semi-structured interviews: 2-4 weeks post intervention; Observations: during intervention
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Plan to share: No
Started Aug 2026 (actual). Primary completion is estimated for Sep 2028, 25 months after the start.
Of 2,877 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 25 months is close to that.
Counting every sponsor, half of 3,006 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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