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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))

1 giugno 2026 aggiornato da: ARLETTE PATRICIA DOUSSOULIN SANHUEZA, Universidad de La Frontera

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.

General Objective To determine the 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. Methodology An experimental design consisting of a single-blind randomized controlled clinical trial is proposed. The study will include two independent groups of women diagnosed with stroke, who will participate in five assessment time points (pre-treatment, intermediate, post-treatment, and two follow-ups). Motor function (Motor Activity Log-30 and ARAT), quality of life (ECVI-38), and therapeutic alliance (CAF-P) will be evaluated. The intervention includes 10 sessions (120 minutes each), delivered daily over a two-week period. The experimental group (EG) will receive CIMT combined with C-tDCS, while the control group (CG) will receive CIMT plus sham C-tDCS (using the standard safety sham protocol commonly known as "FISSFO" [Fade In of Stimulation, Brief Real Stimulation, Fade Out]). In both groups, C-tDCS will be applied during the first 20 minutes of the session simultaneously with the practice of specific upper-limb motor tasks, followed by 100 minutes of CIMT. The CG will receive the same intervention but with sham stimulation, applying current for one minute to generate the initial sensation without producing a physiological effect. Sessions will be conducted in mixed subgroups (two participants from the EG and two from the CG) sharing the same therapeutic space. A proposed sample size of N = 26 (13 patients per group) was calculated considering a statistical power of 80%, assuming a medium effect size of f = 0.25, an error probability α = 0.05, a power (1 - error probability β) = 0.95, and correlations among repeated measures = 0.50. An additional 10% was included to compensate for potential losses during follow-up. Simple random allocation of the sample will be performed using SPSS Statistics 27. Proposed Analysis Plan SPSS Statistics 27 software will be used. Initially, descriptive statistics will be employed to analyze the sample according to sociodemographic and clinical characteristics. Subsequently, Cronbach's alpha reliability coefficient will be calculated to examine the internal consistency of the motor function and quality-of-life variables, both within and between groups and across evaluation time points. The effects of the intervention will be assessed using unifactorial intragroup and intergroup analyses of covariance (ANCOVA). In each ANCOVA, treatment will be considered the independent variable, each motor function and quality-of-life score will be considered the dependent variable, and control variables will be included as covariates. All results with p-values less than or equal to 0.05 in one-tailed tests will be considered statistically significant. Expected Results It is expected that the combination of CIMT and C-tDCS will significantly enhance motor recovery in post-stroke women. The intervention may improve upper-limb function recovery, promote better quality of life, and optimize the therapeutic alliance, resulting in greater participation in daily activities. By modulating cerebellar activity, C-tDCS may facilitate neuronal plasticity and accelerate the response to intensive training. If confirmed, the study will provide evidence for a safe, accessible, and effective neurorehabilitation strategy, opening future low-cost avenues for current rehabilitation practices.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

24

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Araucania
      • Temuco, Araucania, Chile, 4780000
        • Reclutamento
        • Universidad de La Frontera, Temuco, Chile.
        • Contatto:
        • Sub-investigatore:
          • Ornella Bahamondes, Msc
        • Sub-investigatore:
          • Mauro Obreque, Msc

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Altri nomi:
  • CIMT
Comparatore fittizio: 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.

Altri nomi:
  • CIMT

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effects of CIMTm combined with c-tDCS on paretic upper extremity function in women with stroke.
Lasso di tempo: 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.
Effects of CIMTm combined with c-tDCS on paretic upper extremity function in women with stroke.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

26 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 maggio 2026

Primo Inserito (Effettivo)

2 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • Universidad de La Frontera
  • CIMT + ctDCS (Altro identificatore: Universidad de La Frontera)
  • CIMTm + ctDCS (Altro identificatore: Red Neuroaraucanía Chile)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su tDCS

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