NCT07912320Csak meghívásos
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 3.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Csak meghívásos
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2026. szept. 29.
- Kezdés
- 2026. aug. 26.
- Elsődleges befejezés
- 2028. szept.
- Fő szponzor
- KU Leuven
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT07912320
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 100
- 2026. aug. 26. és az elsődleges befejezés (2028. szept.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Más betegség
- 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;
Egyéb
- No ability to initiate movements against gravity in the upper and lower limbs;
- A female who is pregnant or breastfeeding.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| AZ Herentals | Herentals | Belgium | Ismeretlen állapot |
| KU Leuven | Leuven | Belgium | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.