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Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease

Not Recruiting
18 years of age
Both
Phase 2/3

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Overview

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.

Eligibility

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.

Study details

Stroke, Spinal Cord Injuries, Chronic Disease

NCT05970367

KU Leuven

14 February 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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