Trial · NCT07912320
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change 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 |
| Primary | Change 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 |
| Primary | Change 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 |
| Secondary | Change 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 |
| Secondary | Change 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 |
| Secondary | Change 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 |
| Secondary | Change 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 |
| Secondary | Change 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 |
| Other | Determinants 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). |
| Other | Health economic evaluation | Long-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. |
| Other | Process evaluation | 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 participants, therapists, hospital management, and other relevant stakeholders will explore the feasibility, acceptability, perceived benefits, barriers and facilitators to implementation, and opportunities for future implementation of the programme. 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, totalling 6-7 hours per participant per week. Observations will help interpret outcome variations across settings. This outcome represents a mixed-methods process evaluation. The above mentioned complementary sources will be triangulated. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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