Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease (INTeRAcT)

Catholic University (KU) of Leuven

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Chronic Disease; Spinal Cord Injuries; Stroke

Treatments: Other: Intensive rehabilitation programme

Study type: Interventional

Funder types: Other

Identifiers

NCT05970367

S67164

Details and patient eligibility

About

This project will consist of 1 large clinical trial with 2 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intensive rehabilitation program

Experimental group

Description:

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

Treatment:

Other: Intensive rehabilitation programme

Standard care

No Intervention group

Description:

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