Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease

Phase 2

Recruiting

• Conditions: Stroke; Spinal Cord Injuries; Chronic Disease

• Registration Number: NCT05970367
• Lead Sponsor: KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-6-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Voluntary written informed consent of the participant or their legally authorized<br> representative has been obtained prior to any screening procedures;<br><br> 2. A diagnosis of central neurological disease, made by a specialist. Conditions may<br> include stroke or spinal cord injury:<br><br> 1. Stroke: Participants must have received a diagnosis of stroke for the first<br> time, have been diagnosed at least 3 months ago, and live at home.<br><br> 2. SCI: Participants have a rating A, B, C or D on the American Spinal Injury<br> Association (ASIA) measurement scale, which refers to patients with complete or<br> incomplete impairment. All levels of SCI can be included, if there is a clear<br> patient need linked to the upper and/or lower extremities.<br><br> 3. At least 3 months post discharge from hospital/rehabilitation centre, living at<br> home;<br><br> 4. Having a maximum recovery of 85% of independence in daily functioning (FIM/SCIM);<br><br> 5. Had a normal functional state prior to the pathology: a pre-pathology Barthel Index<br> > 85/100;<br><br> 6. Unilateral or bilateral weakness of the affected upper or lower limbs (No maximum<br> score in all affected limbs = motricity index: score 5 on 3/3 segments)<br><br> 7. Having the clinical opportunity to engage in exercise therapy with available<br> technology, assessed by a specialist;<br><br> 8. Age of > 18 years;<br><br> 9. Sufficient cognitive ability to understand the games and give informed consent,<br> assessed by a specialist;.<br><br>Exclusion Criteria:<br><br> 1. Having other neurological or musculoskeletal conditions that may affect the<br> protocol, assessed by a specialist;<br><br> 2. No ability to initiate movements against gravity in the upper and lower limbs;<br><br> 3. Severe visual impairment, communication, cognitive and language formation problems<br> that would prevent the intervention and measurement process, assessed by a<br> specialist;<br><br> 4. Any disorder, which in the investigator's opinion might the compromise participant's<br> safety or compliance with the CIP;<br><br> 5. Female who is pregnant, breast-feeding.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Functional Independence Measure (FIM);Change in Spinal Cord Independence Measure (SCIM)

Secondary Outcome Measures

Name	Time	Method
Change in The Canadian Occupational Performance Measure (COPM);Change in EQ-5D-5L;Change in Goal Attainment Scaling (GAS);Change in The fatigue severity scale (FSS);Borg Rating of Perceived Exertion Scale;Change in the 6-minute Walk-Test (6MWT);Change in the action research Arm Test (ARAT);Change in rhe Fugl-Meyer Assessment (FMA);Change in the functional Ambulation Classification (FAC);Change in the 10 Meter Walk Test (10MWT);Change in the Stroke Self-efficacy Questionnaire