Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease

NCT05970367 | Completed

• 1 other identifier: S67164
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Disease; Stroke; Spinal Cord Injuries

Keywords

rehabilitation; intensive; technology

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline - 3weeks - 9months

Secondary Outcomes (11)

• Change in The Canadian Occupational Performance Measure (COPM)

  Baseline - 3weeks - 9months

• Change in EQ-5D-5L

  Baseline - 3weeks - every month during follow-up - 9 months

• Change in Goal Attainment Scaling (GAS)

  Baseline - 3weeks - 9months

• Change in The fatigue severity scale (FSS)

  Baseline - 3weeks - 9months

• Borg Rating of Perceived Exertion Scale

  During intervention (up to 9 months)

Other Outcomes (3)

• Change in health economic evaluation

  Baseline - 3weeks - every month during follow-up - 9 months

• Therapy diary

  every month during follow-up (up to 9 months)

• Process evaluation

  Structured therapy diaries: during intervention; Semi-structured interviews: 2-4 weeks post intervention; Observations: during intervention

Study Arms (2)

Intensive rehabilitation program

EXPERIMENTAL

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

Other: Intensive rehabilitation programme

Standard care

NO INTERVENTION

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

Interventions

Intensive rehabilitation programme OTHER

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.

Intensive rehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures;
• A diagnosis of central neurological disease, made by a specialist. Conditions may include stroke or spinal cord injury:
• 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.
• 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.
• At least 3 months post discharge from hospital/rehabilitation centre, living at home;
• Having a maximum recovery of 85% of independence in daily functioning (FIM/SCIM);
• Had a normal functional state prior to the pathology: a pre-pathology Barthel Index \> 85/100;
• 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)
• Having the clinical opportunity to engage in exercise therapy with available technology, assessed by a specialist;
• Age of \> 18 years;
• Sufficient cognitive ability to understand the games and give informed consent, assessed by a specialist;.

You may not qualify if:

• Having other neurological or musculoskeletal conditions that may affect the protocol, assessed by a specialist;
• No ability to initiate movements against gravity in the upper and lower limbs;
• Severe visual impairment, communication, cognitive and language formation problems that would prevent the intervention and measurement process, assessed by a specialist;
• Any disorder, which in the investigator's opinion might the compromise participant's safety or compliance with the CIP;
• Female who is pregnant, breast-feeding.

Sponsors & Collaborators

• KU Leuven: lead
• AZ Herentals: collaborator
• Vrije Universiteit Brussel: collaborator

Study Sites (2)

AZ Herentals

Herentals, 2200, Belgium

Location

KU Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries; Chronic Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Randomised controlled trial (RCT)

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: August 1, 2023
• Study Start: July 10, 2023
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)