Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease (NCT05970367) | Clinical Trial Compass
CompletedNot Applicable
Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease
Belgium102 participantsStarted 2023-07-10
Plain-language summary
This project will consist of 1 large clinical trial with 3 core concepts: (1) Clinical benefits of an intensive rehabilitation programme using advanced technology, compared to the control group; (2) A full health economic evaluation combined with model-based estimation of costs and benefits; (3) process evaluation.
Who can participate
Age range18 Years
SexALL
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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:
✓. Stroke: Participants must have received a diagnosis of stroke for the first time, have been diagnosed at least 3 months ago, and live at home.
✓. 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 centre, living at home;
✓. Having a maximum recovery of 85% of independence in daily functioning (FIM/SCIM);
✓. 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)
Exclusion criteria
✕. Having other neurological or musculoskeletal conditions that may affect the protocol, assessed by a specialist;
✕. 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;
✕. Any disorder, which in the investigator's opinion might the compromise participant's safety or compliance with the CIP;