Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease (INTeRAcT)

January 8, 2026 updated by: Prof Geert Verheyden, KU Leuven

Impact of an Intensive Motor Rehabilitation Programme Integrating Technology for Adults With Central Neurological Disease: A Randomised Controlled Rehabilitation Study in the Chronic Phase

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Herentals, Belgium, 2200
        • AZ Herentals
      • Leuven, Belgium, 3000
        • KU Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intensive rehabilitation program
3 weeks of intensive rehabilitation --> follow-up 9 months standard care
Other: Intensive rehabilitation programme

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.
No Intervention: Standard care
Follow-up 9 months standard care --> 3 weeks of intensive rehabilitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Functional Independence Measure (FIM)
Time Frame: Baseline - 3weeks - 9months

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)
Time Frame: Baseline - 3weeks - 9months

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in The Canadian Occupational Performance Measure (COPM)
Time Frame: Baseline - 3weeks - 9months

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
Baseline - 3weeks - 9months
Change in EQ-5D-5L
Time Frame: Baseline - 3weeks - every month during follow-up - 9 months

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
Baseline - 3weeks - every month during follow-up - 9 months
Change in Goal Attainment Scaling (GAS)
Time Frame: Baseline - 3weeks - 9months

Goal Attainment Scaling (GAS), is an individualised evaluation method. It is scored on an ordinal 5-point scale, which captures a person's individual treatment goal and is scored afterwards on the achievement of that treatment goal. The GAS can and will be used for both stroke and spinal cord injury.

Min: -2; Max: +2; Higher = better
Baseline - 3weeks - 9months
Change in The fatigue severity scale (FSS)
Time Frame: Baseline - 3weeks - 9months

The fatigue severity scale (FSS) contains 9 questions assessing the perceived severity of fatigue symptoms in the past week in various daily situations. The patient indicates the extent to which fatigue determines functioning. Again, this will be used for both stroke and spinal cord injury.

Min: 9; Max: 63; Higher = worse
Baseline - 3weeks - 9months
Borg Rating of Perceived Exertion Scale
Time Frame: During intervention (up to 9 months)

During the intervention the Borg Rating of Perceived Exertion Scale will be completed to after every therapy block to assess subjective experiences of the patients during physical load.

Min: 6; Max: 20; Higher = worse
During intervention (up to 9 months)
Change in the 6-minute Walk-Test (6MWT)
Time Frame: Baseline - 3weeks - 9months (stroke only)
The 6-minute Walk-Test (6MWT) is used to measure functional capacity. The maximum distance the patient can cover within 6 minutes is measured.
Baseline - 3weeks - 9months (stroke only)
Change in the action research Arm Test (ARAT)
Time Frame: Baseline - 3weeks - 9months (stroke only)

The action research Arm Test (ARAT) is an observational measure to assess upper extremity performance (coordination, dexterity and functioning), including 19 items. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally).

Min: 0; Max: 57; Higher = better
Baseline - 3weeks - 9months (stroke only)
Change in rhe Fugl-Meyer Assessment (FMA)
Time Frame: Baseline - 3weeks - 9months (stroke only)

The Fugl-Meyer Assessment (FMA) is designed to assess motor functioning in upper and lower limbs, in patients with post-stroke. Patients are assessed on 50 test items and on an ordinal 3-point scale.

Min: 0; Max: 100; Higher = better
Baseline - 3weeks - 9months (stroke only)
Change in the functional Ambulation Classification (FAC)
Time Frame: Baseline - 3weeks - 9months (stroke only)

The functional Ambulation Classification (FAC): is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient needs when walking, whether or not they use a personal assistive device.

Min: 0; Max: 5; Higher = better
Baseline - 3weeks - 9months (stroke only)
Change in the 10 Meter Walk Test (10MWT)
Time Frame: Baseline - 3weeks - 9months (stroke only)
The 10 Meter Walk Test (10MWT) measures the time needed for a person to walk 10 meters. It is used to determine functional mobility and gait.
Baseline - 3weeks - 9months (stroke only)
Change in the Stroke Self-efficacy Questionnaire
Time Frame: Baseline - 3weeks - 9months (stroke only)

The Stroke Self-efficacy Questionnaire Evaluate individuals' confidence in carrying out activities of daily living.

Min: 0; Max: 60; Higher = better
Baseline - 3weeks - 9months (stroke only)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in health economic evaluation
Time Frame: Baseline - 3weeks - every month during follow-up - 9 months

Through this questionnaire, health economic data are surveyed to estimate direct and indirect costs that participants have due to their condition.

The following types of resource use will be collected: primary care, emergency visits, inpatient stays, outpatient services, medication, transport costs, the estimation of the amount of informal care, days away from work, and social benefits (e.g. sickness leave payments).
Baseline - 3weeks - every month during follow-up - 9 months
Therapy diary
Time Frame: every month during follow-up (up to 9 months)
Using a therapy diary that the investigators ask patients to fill in every time they have been to the physical therapist/psychologist. On a monthly basis, these records are requested via mail.
every month during follow-up (up to 9 months)
Process evaluation
Time Frame: Structured therapy diaries: during intervention; Semi-structured interviews: 2-4 weeks post intervention; Observations: during intervention

Structured therapy diaries will document how the intervention is delivered, including session duration and the content of the of exercises.

Semi-structured interviews with patients and therapists will assess therapy quality, perceived benefits, relevance, satisfaction, and barriers to implementation, as well as expectations for sustainability. Therapists will reflect on adaptations made.

Observations will deepen understanding of content and delivery: 14 participants will be observed during sessions using a structured scheme. Each therapy type (upper/lower limb, with/without technology, cardiovascular fitness, goal-oriented training, self-management) will be observed weekly over 3 weeks, totaling 6-7 hours per participant per week. Observations will help interpret outcome variations across settings.
Structured therapy diaries: during intervention; Semi-structured interviews: 2-4 weeks post intervention; Observations: during intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vrije Universiteit Brussel
AZ Herentals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S67164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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