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Trial · NCT07912320

Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)

NCT07912320, Not applicable, Enrolling by invitation, KU Leuven

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis). Trials, record NCT07912320. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07912320

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
NCT number
NCT07912320
Status
Enrolling by invitation
Phases
Not applicable
Enrollment
100 participants, estimated
Lead sponsor
KU Leuven
Conditions
Stroke, Spinal Cord Injuries (SCI), Chronic Disease
Interventions
Intensive rehabilitation programme
First posted
2026-11-03
Last updated
2026-11-03

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Functional Independence Measure (FIM)
Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
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
PrimaryChange in Spinal Cord Independence Measure (SCIM)
Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
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
PrimaryChange in Goal Attainment Scaling (GAS)
Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
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
SecondaryChange in The Canadian Occupational Performance Measure (COPM)
Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
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
SecondaryChange in EQ-5D-5L
Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
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
SecondaryChange in General Self-Efficacy Scale (GSES)
Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Assesses one's overall confidence in one's own ability to cope with stressful or challenging situations. Min: 10; Max: 40; Higher = better
SecondaryChange in Function In Sitting Test (FIST)
Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Evaluation of sitting balance that evaluates sensory, motor, proactive, reactive, and steady state balance factors. Min: 0; Max: 54; Higher = better
SecondaryChange in strength (Handheld dynamometer key movements)
Long-term follow-up / pre-boost assessment (approximately 3 years after the original INTeRAcT intervention) and Post-boost assessment (i.e., immediately after completion of the 3-week rehabilitation boost programme).
Muscle strength is measured using a handheld dynamometer for the following movements: * Shoulder flexion * Elbow extension * Wrist dorsiflexion * Knee extension * Ankle dorsiflexion
OtherDeterminants of therapy success
Long-term follow-up / pre-boost assessment (+/- 3 years after the original INTeRAcT intervention): OCS, ECAS, VAS scales, SADL and General self-efficacy questionnaire Post-boost assessment: Intrinsic Motivation Inventory (IMI)
An exploratory analysis will be conducted to investigate determinants of therapy success. Candidate predictors include age, disease severity, cognition (measured using the Oxford Cognitive Screen (OCS) and the Edinburgh Cognitive and Behavioural ALS Screen (ECAS), for the stroke and SCI population, respectively), motivation (measured using the Intrinsic Motivation Inventory (IMI) \& VAS-scale per goal), disease insight (Self-Awareness in Daily Life; SADL-3), and self-efficacy (General self-efficacy questionnaire).
OtherHealth economic evaluationLong-term follow-up, approximately 3 years after completion of the original INTeRAcT intervention
Health economic data are collected to estimate direct medical, direct non-medical, and indirect costs associated with participants' condition during the period between completion of the original INTeRAcT study and the start of INTeRAcT-bis. The following types of resource use will be assessed: healthcare utilisation (including emergency visits, hospitalisations, outpatient care, medication use, and rehabilitation-related care), transport costs, home care support, use of assistive devices, informal care, productivity losses (e.g., days away from work), and other relevant health-related events.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
42095779BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07912320

GET https://conductscience.org/api/trials/v1/NCT07912320/registered