- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05476302
Effect of Remote Cognitive Intervention in Patients With Parkinson's Disease During the COVID-19 Pandemic (TELEPARK)
26 juli 2022 uppdaterad av: Istituto Nazionale di Ricovero e Cura per Anziani
Retrospective study to evaluate the effect of a remote cognitive-rehabilitative intervention during the Covid outbreak in subjects with Parkinson's disease.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
Mild cognitive impairment is frequent among people with Parkinson's disease.
Cognitive training seems effective on cognitive status and for mitigating anxiety and depression.
With COVID-19 outbreak, such therapeutic interventions were delivered online.
This retrospective study was aimed at evaluating the effectiveness of an online cognitive treatment, carried out in COVID times and based on the Parkinson's-Adapted Cognitive Stimulation Therapy, on cognitive domains and mood in 18 older people with Parkinson's disease.
Studietyp
Observationell
Inskrivning (Faktisk)
18
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Ancona, Italien, 60127
- IRCCS INRCA Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Patients with Parkinson's disease that, after eight months of COVID-19 lockdown when all interventions were suspended, received an intensive digital cognitive rehabilitation treatment.
Beskrivning
Inclusion Criteria:
- Parkinson disease: Hoehn & Yahr's scale: 1-3 based on the UK PD Society Brain Bank
- mild cognitive impairment
- no cognitive training between March and October 2020
- presence of a family caregiver to access and use the online platform
Exclusion Criteria:
- other neurological diseases
- deep brain stimulation
- schizophrenia
- depression
- sensory deprivations that could interfere with the treatment
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Cognitive digital treatment
Cognitive digital treatment in patients with Parkinson's disease
|
The remote cognitive-rehabilitation treatment was based on Parkinson's adapted cognitive stimulation therapy (CST).
Fourteen twice-weekly sessions were planned, followed by one session per week for a duration of six months for maintenance therapy.
The treatment took place in groups of 4 patients in remote mode through the Microsoft-Teams platform.
All subjects maintained the prescribed drug therapy and regular physiotherapy activity during the intervention.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
changes in cognitive status
Tidsram: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
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The Mini Mental State Examination (MMSE) was used to evaluate the cognitive status.The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function.
|
This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
changes in cognitive domains
Tidsram: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
The Addembrooke's Cognitive Examination Battery (ACE-R) was used to evaluate the cognitive domains.
The ACE-R consists of six components evaluating separate cognitive domains.
A maximum score of 100 is weighted as follows: orientation (10), attention (8), memory(35), verbal fluency (14), language (28), and visuospatialability (5).
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This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
|
changes in thymic state
Tidsram: This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
The Geriatric Depression Scale-15 items (GDS-15 items) was used to evaluate the tymic state.This instrument evaluated depressive symptoms using yes/no answers.
Scores range between 0 and 15 points.
Higher scores indicate more severe depressive symptoms.
|
This evaluation was performed in the pre-COVID-19 period, at the beginning of the remote treatment (8 months from the pre-COVID evaluation), and at the end of the remote treatment (7 weeks from the start of the treatment)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2020
Primärt slutförande (Faktisk)
31 oktober 2020
Avslutad studie (Faktisk)
31 oktober 2020
Studieregistreringsdatum
Först inskickad
22 juli 2022
Först inskickad som uppfyllde QC-kriterierna
26 juli 2022
Första postat (Faktisk)
27 juli 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 juli 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juli 2022
Senast verifierad
1 juli 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Coronavirusinfektioner
- Coronaviridae-infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Luftvägsinfektioner
- Luftvägssjukdomar
- Lunginflammation, Viral
- Lunginflammation
- Lungsjukdomar
- Neurokognitiva störningar
- Parkinsons sjukdom
- Basala ganglia sjukdomar
- Rörelsestörningar
- Synukleinopatier
- Neurodegenerativa sjukdomar
- Kognitionsstörningar
- Covid-19
- Parkinsons sjukdom
- Kognitiv dysfunktion
Andra studie-ID-nummer
- INRCA_004_2022
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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