Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)

NCT07912320 · tracked via the Priya Life Science Belgium tracker

Sponsor

KU Leuven

Phase

Not applicable

Started

2026-08-26

Last updated

2026-11-03

Condition(s) studied

StrokeSpinal Cord Injuries (SCI)Chronic Disease

Investigational drug(s) / intervention(s)

Intensive rehabilitation programme

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.

Study 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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: 1. 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. 2. 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. * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Change in Functional Independence Measure (FIM) — 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) — 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) — 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

Trial sites (2)

Facility	City	Region	Status
AZ Herentals	Herentals	Belgium
KU Leuven	Leuven	Belgium

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07912320 on ClinicalTrials.gov ↗ ← All trials in Belgium