Status:
COMPLETED
Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease
Lead Sponsor:
KU Leuven
Collaborating Sponsors:
AZ Herentals
Vrije Universiteit Brussel
Conditions:
Stroke
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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)
- Having the clinical opportunity to engage in exercise therapy with available technology, assessed by a specialist;
- Age of \> 18 years;
- Sufficient cognitive ability to understand the games and give informed consent, assessed by a specialist;.
Exclusion
- 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;
- Female who is pregnant, breast-feeding.
Key Trial Info
Start Date :
July 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2025
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT05970367
Start Date
July 10 2023
End Date
July 9 2025
Last Update
January 9 2026
Active Locations (2)
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1
AZ Herentals
Herentals, Belgium, 2200
2
KU Leuven
Leuven, Belgium, 3000