- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07619703
Effects of a Neurorehabilitation Program Based on CIMT and Non-invasive Neuromodulation Through C-tDCS on the Recovery of Paretic Upper Limb Function, Quality of Life, and Therapeutic Alliance in Women From the Araucanía Region Who Suffered a Stroke (CIMT + tDCS). ((CIMT - tDCS))
Effects of a Neurorehabilitation Program Based on Constraint-Induced Movement Therapy (CIMT) and Non-invasive Neuromodulation Through Cerebellar Transcranial Direct Current Stimulation (C-tDCS) on the Recovery of Paretic Upper Limb Function, Quality of Life, and Therapeutic Alliance in Women From the Araucanía Region Who Suffered a Stroke.
Studieöversikt
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Arlette Doussoulin, PhD
- Telefonnummer: +56997445912
- E-post: arlette.doussoulin@ufrontera.cl
Studieorter
-
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Araucania
-
Temuco, Araucania, Chile, 4780000
- Rekrytering
- Universidad de La Frontera, Temuco, Chile.
-
Kontakt:
- Arlette Doussoulin, Phd Human Motricity
- Telefonnummer: 997445912
- E-post: arlette.doussoulin@ufrontera.cl
-
Underutredare:
- Ornella Bahamondes, Msc
-
Underutredare:
- Mauro Obreque, Msc
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Women aged between 30 and 80 years.
- Who present hemorrhagic or ischemic stroke confirmed by CT with evolution greater than 1 month, corroborated by discharge epicrisis supporting the diagnosis of the patient.
- Who presents trunk control in sitting.
- Score greater than 14 points on the Minimental Examination scale.
- Function of the upper extremity, referring to taking and releasing a small ball with the affected hand and signing or accepting the consent written informed.
Exclusion Criteria:
- Shoulder pain greater than 4 according to the VAS scale and spasticity greater than 2 according to the Modified Ashworth Scale.
- Sensory compromise (visual-auditory).
- Presence of severe aphasia.
- Cochlear implants, aneurysm clips, brain electrodes and cardiac pacemaker.
- Epilepsy or psychiatric disorders (diagnosed in the last 3 months).
- Pregnancy, use of psychotropic medications.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: CIMTm y ctDCS
c-tDCS will be applied during the first 20 minutes of the session simultaneously with the practice of motor tasks of specific movements aimed at the upper extremity, continuing the session with 100 minutes of CIMTm.
|
Intervention: The protocol will be carried out in a total of 10 sessions, with a daily frequency over a period of 2 weeks. Experimental group: The c-tDCS will be applied for the first 20 minutes, along with the performance of the first motor tasks associated with CIMTm. To do this, a direct current of between 1.5 to 2 mA will be used in the right cerebellar hemisphere. The CIMTm will be implemented with a duration of 120 minutes and consists of 3 components: repetitive task training, use of a glove on the healthy hand and behavioral transfer package. Control group: The electrodes will be located in the same position of the EG, but simulated stimulation (sham) will be used, which will consist of the application of an initial current that will be maintained for one minute with a 30-second ramp until reaching 1.5 mA and a 30-second descending ramp, after which the device will turn off (program available on the equipment). The CIMTm session is the same as the experimental group.
Andra namn:
|
|
Sham Comparator: CIMTm y ctDCS sham
c-tDCS (sham) will be used, which will consist of the application of an initial current that will be maintained for one minute with a 30-second ramp until reaching 1.5 mA and a 30-second descending ramp, after which the device will turn off (program available on the device).
|
Intervention: The protocol will be carried out in a total of 10 sessions, with a daily frequency over a period of 2 weeks. Experimental group: The c-tDCS will be applied for the first 20 minutes, along with the performance of the first motor tasks associated with CIMTm. To do this, a direct current of between 1.5 to 2 mA will be used in the right cerebellar hemisphere. The CIMTm will be implemented with a duration of 120 minutes and consists of 3 components: repetitive task training, use of a glove on the healthy hand and behavioral transfer package. Control group: The electrodes will be located in the same position of the EG, but simulated stimulation (sham) will be used, which will consist of the application of an initial current that will be maintained for one minute with a 30-second ramp until reaching 1.5 mA and a 30-second descending ramp, after which the device will turn off (program available on the equipment). The CIMTm session is the same as the experimental group.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Effects of CIMTm combined with c-tDCS on paretic upper extremity function in women with stroke.
Tidsram: From enrollment to the end of treatment at 8 weeks.
|
Evaluated through the Action Research Arm Test (pre- and post-treatment): scale that evaluates both arms in order to obtain a total description of the function of the upper extremity, after a cortical injury.
It is made up of 19 items grouped into 4 subtests: grip, grasp, clamp, gross movement.
All items are evaluated on a 4-point scale from 0 (no movement) to 3 (normal movement).
This measure has been widely validated in Spanish-American speaking countries, thereby obtaining its degree of reliability and instrumental validity.
The reliability analysis using Cronbach's alpha obtained in the studies was 0.96, indicating high internal consistency.
|
From enrollment to the end of treatment at 8 weeks.
|
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Effects of CIMTm combined with c-tDCS on paretic upper extremity function in women with stroke.
Tidsram: From enrollment to the end of treatment at 4 weeks.
|
Evaluated through the Action Research Arm Test (pre-postreatment), a scale that evaluates both arms in order to obtain a total description of the function of the upper extremity, after a cortical injury.
It is made up of 19 items grouped into 4 subtests: grip, grasp, clamp, gross movement.
All items are evaluated on a 4-point scale from 0 (no movement) to 3 (normal movement).
This measure has been widely validated in Spanish-American speaking countries, thereby obtaining its degree of reliability and instrumental validity.
The reliability analysis using Cronbach's alpha obtained in the studies was 0.96, indicating high internal consistency.
|
From enrollment to the end of treatment at 4 weeks.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Cerebrovaskulära störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Stroke
- Terapeutik
- Beteendediscipliner och aktiviteter
- Elektrisk stimuleringsterapi
- Krampbehandling
- Psykiatriska somatiska terapier
- Elchock
- Psykologiska tekniker
- Transkraniell likströmsstimulering
Andra studie-ID-nummer
- Universidad de La Frontera
- CIMT + ctDCS (Annan identifierare: Universidad de La Frontera)
- CIMTm + ctDCS (Annan identifierare: Red Neuroaraucanía Chile)
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