NCT07912320Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
Rehabilitation remains important in the chronic phase after stroke or spinal cord injury, as meaningful improvements may still be achieved through intensive, goal-directed, and personalized training. INTeRAcT-bis is a follow-up study of the original INTeRAcT program, which consisted of a 3-week intensive rehabilitation intervention (90 therapy hours) combining conventional therapy, goal-directed training, self-management, and advanced rehabilitation technologies. The study has two main objectives: (1) to evaluate the long-term clinical and health economic effects of the original INTeRAcT program, and (2) to assess the clinical effects and implementation of a second intensive rehabilitation period ("boost"). Participants receive a personalized 3-week rehabilitation program targeting upper and/or lower limb impairments based on their individual goals. In addition to clinical and health economic outcomes, the study examines participant experiences and implementation factors to support a broader implementation of intensive rehabilitation in the future.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 29 Sept 2026
- Start date
- 26 Aug 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- KU Leuven
- Diseases
- Stroke
- NCT number
- NCT07912320
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 26 Aug 2026 to the primary completion date, Sept 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Having other neurological or musculoskeletal conditions that may affect the protocol, assessed by a specialist (under supervision of an MD);
- Severe visual impairment, communication, cognitive, and language formation problems that would prevent the intervention and measurement process, assessed by a specialist (under supervision of an MD);
- Any disorder, which in the investigator's opinion might compromise the participant's safety or compliance with the CIP;
Other
- No ability to initiate movements against gravity in the upper and lower limbs;
- A female who is pregnant or breastfeeding.
Who the study is looking for
- 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 and have been diagnosed at least 3 months ago.
- Participants who are diagnosed for the second time, but returned to normal functioning after the first stroke diagnosis (Barthel Index \> 85/100), and the affected side is the same as the first stroke.
- 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 center, living at home;
- 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 (under supervision of an MD);
- Age of \> 18 years;
- Sufficient cognitive ability to understand the therapy exercises and give informed consent, assessed by a specialist (under supervision of an MD);
- Having participated in the first INTeRAcT study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Herentals Coordinator of this site? Confirm its status | Herentals | Belgium | Unknown status |
| KU Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.