NCT05769972Befejeződött
Efficacy of Cognitive Rehabilitation Using Virtual Reality and Computer-based Cognitive Stimulation on Cognitive Impairment Associated to Movement Disorders
Randomized, Single-blind Clinical Trial to Evaluate the Efficacy of Cognitive Rehabilitation Using Inmersive Virtual Reality and Computer-based Cognitive Stimulation Versus Music Therapy on Cognitive Impairment Associated With Movement Disorders
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. nov. 18.
Rövid összefoglaló (regiszter, angolul)
Mild cognitive impairment associated with movement disorders occurs in up to one third of patients in early stages of the disease, and confers an increased risk of developing dementia. Non-pharmacological interventions to improve cognition have so far been based on computer-based cognitive stimulation and rehabilitation programs. These interventions base their mechanism of action on neuroplasticity and how improvements in cognitive function will generalize to functional improvement. Despite having shown certain indicators of efficacy in previous exploratory studies and clinical trials, cognitive rehabilitation continues to show insufficient evidence and requires further study. To date, there are no previous studies using immersive virtual reality (IVR) to improve cognition. Both IVR and cognitive stimulation are based on the premise that they allow the simulation of ecological environments for rehabilitation than conventional rehabilitation, as well as being more efficient by allowing control of extraneous variables and providing safe spaces for patients. The only PD rehabilitation studies that have been conducted using IVR aimed to improve gait and balance disturbances compared to conventional physiotherapy treatment or non-immersive virtual reality (NIVR). We hypothesize that a cognitive rehabilitation program using IVR or computer-mediated cognitive stimulation could have a greater beneficial effect on the cognitive status of patients with cognitive impairment associated with movement disorders compared to other modalities such as music therapy, delaying the worsening of cognitive functions.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 64 (tényleges)
- Első benyújtás
- 2023. márc. 3.
- Kezdés
- 2021. okt. 13.
- Elsődleges befejezés
- 2022. szept. 21.
- Fő szponzor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Betegségek
- Huntington-kór, Parkinson-kór
- NCT-szám
- NCT05769972
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 64
- 2021. okt. 13. és az elsődleges befejezés (2022. szept. 21.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Patients who were under experimental treatment in the 2 months prior to the selection period.
Más betegség
- Patients with severe vision or hearing impairment.
- History of deep brain stimulation surgery.
- Patients diagnosed with severe dementia (possible or probable) associated with Parkinson's disease, according to the Clinical Diagnostic Criteria for Dementia Associated with PD with a score of >2 on the CRD or with Huntington's disease.
- Patients with any of the following conditions:
- Any severe or uncontrolled medical condition.
- Patients with a history of poor treatment compliance or drug/alcohol abuse that may interfere with the patient's ability to comply with the study protocol or give informed consent.
- Contraindications for MRI*.
- Except for patients with Parkinson's disease (PD), since MRI is optional for these patients. Therefore, if there are contraindications for MRI, they can still participate without undergoing MRI.
Egyéb
- Illiterate patients.
- Patients with active psychosis in the form of incapacitating delusional ideation.
- Life expectancy of less than 6 months.
- Pregnancy or breastfeeding.
Kiket keres a vizsgálat
- Patient capable of understanding, signing and dating the written informed consent at baseline visit prior to randomization.
- Patient diagnosed with Parkinson's disease (Movement Disorder Society PD Criteria) or Huntington's disease.
- Patient with Hoehn and Yahr stage I-III for PD, and Shoulson and Fahn stage I-II for HD.
- Patient with a score on the Parkinson's Disease Cognitive Rating Scale (PD-CRS) >83, who present subjective memory complaints will be included in "group I: subjective memory complaints".
- Patient with a score on the Parkinson's Disease Cognitive Rating Scale (PD-CRS) between 64 and 83, both inclusive, will be included in "group II: mild cognitive impairment".
- Patient diagnosed with Parkinson's disease with stable dopaminergic treatment in the last 4 weeks.
- Patient capable and willing to comply with study visits as detailed in the protocol.
Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Barcelona | Spanyolország | Ismeretlen állapot |
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