Clinical trial NCT05970367: Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease
Official title: Impact of an Intensive Motor Rehabilitation Programme Integrating Technology for Adults With Central Neurological Disease: A Randomised Controlled Rehabilitation Study in the Chronic Phase
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Spinal Cord Injuries
Chronic Disease
Keywords: rehabilitation
intensive
technology
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: AZ Herentals
name: Vrije Universiteit Brussel
First posted: 2023-08-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial (RCT)
Primary purpose: TREATMENT

Brief summary: 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 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.

Primary outcomes:
measure: Change in Functional Independence Measure (FIM)
timeFrame: Baseline - 3weeks - 9months
measure: Change in Spinal Cord Independence Measure (SCIM)
timeFrame: Baseline - 3weeks - 9months
Secondary outcomes:
measure: Change in The Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline - 3weeks - 9months
measure: Change in EQ-5D-5L
timeFrame: Baseline - 3weeks - every month during follow-up - 9 months
measure: Change in Goal Attainment Scaling (GAS)
timeFrame: Baseline - 3weeks - 9months
measure: Change in The fatigue severity scale (FSS)
timeFrame: Baseline - 3weeks - 9months
measure: Borg Rating of Perceived Exertion Scale
timeFrame: During intervention (up to 9 months)
measure: Change in the 6-minute Walk-Test (6MWT)
timeFrame: Baseline - 3weeks - 9months (stroke only)
measure: Change in the action research Arm Test (ARAT)
timeFrame: Baseline - 3weeks - 9months (stroke only)
measure: Change in rhe Fugl-Meyer Assessment (FMA)
timeFrame: Baseline - 3weeks - 9months (stroke only)
measure: Change in the functional Ambulation Classification (FAC)
timeFrame: Baseline - 3weeks - 9months (stroke only)
measure: Change in the 10 Meter Walk Test (10MWT)
timeFrame: Baseline - 3weeks - 9months (stroke only)
measure: Change in the Stroke Self-efficacy Questionnaire
timeFrame: Baseline - 3weeks - 9months (stroke only)
Other outcomes:
measure: Change in health economic evaluation
timeFrame: Baseline - 3weeks - every month during follow-up - 9 months
measure: Therapy diary
timeFrame: every month during follow-up (up to 9 months)
Locations:
city: Herentals
country: Belgium
facility: AZ Herentals
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References: