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StrokeINTeRAcTNCT05970367

Intensive Motor Rehabilitation With Technology for Patients With Central Neurological Disease

A study testing Intensive rehabilitation programme in people with Stroke and Spinal Cord Injuries, run by KU Leuven at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Spinal Cord Injuries, Chronic Disease
What is being tested?
Intensive rehabilitation programme
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
2 sitesBelgium
Study dates
10 Jul 2023to 9 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
Show all 11Show fewer
  • 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;.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • AZ Herentals

    Herentals, 2200

  • KU Leuven

    Leuven, 3000

Other trials in Belgium

About this study

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

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.

Being tested
Intensive rehabilitation programme
Keywords
rehabilitation, intensive, technology
Medical subject headings
Stroke, Spinal Cord Injuries, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05970367
Study groupRoleWhat they receive
Intensive rehabilitation programExperimental3 weeks of intensive rehabilitation --> follow-up 9 months standard care
Receives: Other: Intensive rehabilitation programme
Standard careNo interventionFollow-up 9 months standard care --> 3 weeks of intensive rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline - 3weeks - 9months

  2. 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

    Measured: Baseline - 3weeks - 9months

Secondary outcomes (11)

  1. 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

    Measured: Baseline - 3weeks - 9months

  2. 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

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

  3. Change in Goal Attainment Scaling (GAS)

    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

    Measured: Baseline - 3weeks - 9months

  4. Change in The fatigue severity scale (FSS)

    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

    Measured: Baseline - 3weeks - 9months

  5. Borg Rating of Perceived Exertion Scale

    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

    Measured: During intervention (up to 9 months)

  6. Change in the 6-minute Walk-Test (6MWT)

    The 6-minute Walk-Test (6MWT) is used to measure functional capacity. The maximum distance the patient can cover within 6 minutes is measured.

    Measured: Baseline - 3weeks - 9months (stroke only)

  7. Change in the action research Arm Test (ARAT)

    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

    Measured: Baseline - 3weeks - 9months (stroke only)

  8. Change in rhe Fugl-Meyer Assessment (FMA)

    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

    Measured: Baseline - 3weeks - 9months (stroke only)

  9. Change in the functional Ambulation Classification (FAC)

    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

    Measured: Baseline - 3weeks - 9months (stroke only)

  10. Change in the 10 Meter Walk Test (10MWT)

    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.

    Measured: Baseline - 3weeks - 9months (stroke only)

  11. Change in the Stroke Self-efficacy Questionnaire

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

    Min: 0; Max: 60; Higher = better

    Measured: Baseline - 3weeks - 9months (stroke only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start10 Jul 2023
  3. Primary completion9 Jul 2025
  4. Study completion9 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised controlled trial (RCT)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05970367
Sponsor's protocol ID
S67164
Acronym
INTeRAcT
Status last verified
Jan 2026
First submitted
23 Jun 2023
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Coremans M, Allewijn I, Bataillie F, De Bruyn L, Fobelets M, Jacobs F, Janssens S, Pattyn L, Putman K, Schiltz A, Tedesco Triccas L, Van Thienen F, Verheyden G. Impact of a Personalized, High-Dose, Intensive Motor Rehabilitation Program, Integrating Advanced Technology for Adults With Central Neurological Conditions (INTeRAcT): Protocol for a Single-Blind Randomized Controlled Trial With a Clinical, Health Economic, and Process Evaluation. JMIR Res Protoc. 2026 May 4;15:e93234. doi: 10.2196/93234.

    PubMed 42095779

Questions about this trial

What is this clinical trial studying?

A study testing Intensive rehabilitation programme in people with Stroke and Spinal Cord Injuries, run by KU Leuven at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Functional Independence Measure (FIM) (time frame: Baseline - 3weeks - 9months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05970367, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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