Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease

NCT ID: NCT05970367

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2025-07-09

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 full health economic evaluation combined with model-based estimation of costs and benefits; (3) process evaluation.

Conditions

Stroke; Spinal Cord Injuries; Chronic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive rehabilitation program

3 weeks of intensive rehabilitation --\> follow-up 9 months standard care

Group Type: EXPERIMENTAL

Intensive rehabilitation programme

Intervention Type: OTHER

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.

Standard care

Follow-up 9 months standard care --\> 3 weeks of intensive rehabilitation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures;

2. 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 for the first time, have been diagnosed at least 3 months ago, and live at home.

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.

3. At least 3 months post discharge from hospital/rehabilitation centre, living at home;

4. Having a maximum recovery of 85% of independence in daily functioning (FIM/SCIM);

5. Had a normal functional state prior to the pathology: a pre-pathology Barthel Index > 85/100;

6. 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)

7. Having the clinical opportunity to engage in exercise therapy with available technology, assessed by a specialist;

8. Age of > 18 years;

9. Sufficient cognitive ability to understand the games and give informed consent, assessed by a specialist;.

Exclusion Criteria

1. Having other neurological or musculoskeletal conditions that may affect the protocol, assessed by a specialist;

2. No ability to initiate movements against gravity in the upper and lower limbs;

3. Severe visual impairment, communication, cognitive and language formation problems that would prevent the intervention and measurement process, assessed by a specialist;

4. Any disorder, which in the investigator's opinion might the compromise participant's safety or compliance with the CIP;

5. Female who is pregnant, breast-feeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

AZ Herentals

UNKNOWN

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Prof Geert Verheyden

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AZ Herentals

Herentals, , Belgium

KU Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S67164

Identifier Type: -

Identifier Source: org_study_id