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ENROLLING BY INVITATION

NCT07912320

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

Sponsor: KU Leuven

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-08-26

Completion Date

2028-09

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Stroke Spinal Cord Injuries (SCI)Chronic Disease

Interventions

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.

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.

Locations (2)

AZ Herentals

Herentals, Belgium

KU Leuven

Leuven, Belgium