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).

NCT07619703 | Recruiting DMC

• 3 other identifiers: Universidad de La FronteraCIMT + ctDCSCIMTm + ctDCS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

upper limb; Stroke; CIMT; tDCS

Outcome Measures

Primary Outcomes (2)

• Effects of CIMTm combined with c-tDCS on paretic upper extremity function in women with stroke.

  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.

  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.

Study Arms (2)

CIMTm y ctDCS

EXPERIMENTAL

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.

Other: tDCS

CIMTm y ctDCS sham

SHAM COMPARATOR

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).

Other: tDCS

Interventions

tDCS OTHER

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.

Also known as: CIMT

CIMTm y ctDCS; CIMTm y ctDCS sham

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Universidad de La Frontera, Temuco, Chile.

Temuco, Araucania, 4780000, Chile

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Arlette Doussoulin, PhD

CONTACT

+56997445912; arlette.doussoulin@ufrontera.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor

Model Details: The intervention considers 10 sessions (duration of 120 minutes), with a daily frequency for 2 weeks. The experimental group (EG) will be exposed to CIMT combined with c-tDCS and the control group (CG) will receive CIMT + c-tDCS placebo (or sham modality using the standard safety protocol, commonly known as "FISSFO" (Fade In of Stimulation, Brief Real Stimulation, Fade Out)). In both groups, the 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 CIMT. The CG will receive the same intervention, but with simulated stimulation (sham), applying current for one minute to generate the initial sensation without physiological effect. The sessions will be held in mixed subgroups (two participants per EG and two per CG) sharing the same therapeutic space.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)