Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease

KU Leuven102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

102

Conditions

Stroke Spinal Cord Injuries Chronic Disease

Interventions

Intensive rehabilitation programmeOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

AZ Herentals

Herentals, Belgium

KU Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Change in Functional Independence Measure (FIM)

The Functional Independence Measure (FIM), which measures independence in daily functioning after stroke. The FIM consists of 18 items designed to assess to what extent a person needs assistance in performing activities of daily living safely and efficiently. The activities consist of a number of basic skills related to self-care, pelvic floor function, transfers, gait, communication and social abilities. The FIM has acceptable reliability and has been found valid in people with stroke. Min: 13; Max: 91; Higher = better

Time frame: Baseline - 3weeks - 9months

Change in Spinal Cord Independence Measure (SCIM)

Spinal Cord Independence Measure (SCIM), an assessment of achievements of daily function of patients with spinal cord lesions. The scale consists of 19 tasks organized in 3 subscales: self-care, respiration and sphincter management, and mobility. The SCIM is valid and reliable. Min: 0; Max: 100; Higher = better

Time frame: Baseline - 3weeks - 9months

Secondary Outcomes

Change in The Canadian Occupational Performance Measure (COPM)

The Canadian Occupational Performance Measure (COPM), is an evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living, over time. This outcome can be used in both study populations. Min: 1; Max: 10; Higher = better

Time frame: Baseline - 3weeks - 9months

Change in EQ-5D-5L

EQ-5D-5L, measures quality of life at five levels of health (mobility, self-care, daily activities, pain/discomfort and anxiety/depression). From this, a weighted health index can be calculated for an individual or population. This scale can also be used for both populations. Min: 1; Max: 100; Higher = better

Time frame: Baseline - 3weeks - every month during follow-up - 9 months

Change in Goal Attainment Scaling (GAS)

Data from ClinicalTrials.gov

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