tDCS Combined With Constraint-Induced Therapy in Post-Stroke Upper Limb Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversidade do Estado do Pará
About this trial
The objective of this clinical trial is to evaluate the effects of transcranial direct current stimulation (tDCS) combined with constraint-induced therapy (CIT) on upper limb motor recovery in individuals after stroke.
The main questions it aims to answer are:
Does the combination of tDCS and CIT improve upper limb motor function compared to CIT alone?
Does the combined intervention promote changes in muscle morphology and electromyographic activity?
Researchers will compare the group receiving tDCS combined with constraint-induced therapy to the group receiving constraint-induced therapy alone to determine whether the addition of cortical neuromodulation enhances motor recovery outcomes.
This is a randomized, controlled, and blinded clinical trial in which participants will be divided into two groups: one group will receive tDCS combined with CIMT, and the other will undergo only CIMT. The protocol will include 18 sessions over six weeks, three times a week.
Clinical and instrumental assessments will be performed before, during, and after the intervention, including the Fugl-Meyer scale for the upper limb, musculoskeletal ultrasound for morphological analysis, and surface electromyography for muscle activity assessment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
present a clinical diagnosis of stroke confirmed by imaging examination and/or report issued by a neurologist; - are in the chronic phase of the lesion with an occurrence time greater than six months; - hemiparesis with brachial predominance, mild to moderate motor deficit in the affected upper limb defined by a score between 19 and 55 points on the FMA-UE; - have minimum joint integrity to perform the movements required in the protocol with an active range of motion of at least 20° of wrist extension, 10° of extension of the metacarpophalangeal and interphalangeal joints and 20° of elbow extension considering the standard position of 90° elbow flexion, measured with a Carci® goniometer; - demonstrate the ability to understand and follow simple commands on the Mini Mental State Examination (MMSE) (ANNEX II) with a score higher than 23 points for literate persons and lower than 15 points for illiterate persons.
Disqualifiers
diagnosis of epilepsy; - intracranial metallic implants or implantable electronic devices; - contraindications to transcranial direct current stimulation (tDCS), including skin lesions on the scalp; - severe musculoskeletal limitations that prevent the execution of tasks; - history of recurrent stroke; - associated disabling musculoskeletal and neurological pathologies; (7) use of botulinum toxin in the previous three months; - uncontrolled systemic arterial hypertension or diabetes mellitus; - clinically relevant heart disease; - apraxia and aphasia of comprehension; - fracture and pain during movement or displacement of the affected limb, or pain related to shoulder subluxation. Those who feel uncomfortable, drop out of the research, do not respect the rules established in the Informed Consent Form (APPENDIX C), or do not attend the stages of the study will also be excluded.
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial direct current stimulation (tDCS)
DeviceFor tDCS application, the Microestim tDCS model stimulator (NKL Electronic Products Ltd., Brazil) will be used, with a pair of 5 cm x 7 cm (35 cm2) sponge electrodes, which will be soaked in saline solution providing a current density of 0.04 mA/cm2 that will be within safety limits (Russo et al 2017). Regarding electrode placement, the anodic electrode will be fixed over the primary motor cortex (M1) of the affected hemisphere, corresponding to point C3 or C4, according to the international 10-20 electroencephalography system. The cathodic electrode will be positioned over the primary motor cortex of the unaffected hemisphere, at point C4 or C3, respectively, according to the same system. This choice was based on a study by Sun Ho et al (2021) that studied the effects of tDCS and ICT to improve upper limb function after stroke. Volunteers in the a-ETCC group will undergo anodal stimulation at M1 with constant direct current at an intensity of 2 mA, for 20 minutes per session.
Constraint-induced movement therapy
BehavioralAt the time of applying CIMT, a sling will be used positioned on the healthy upper limb (UL), then the affected or paretic UL will be stimulated to perform tasks involving activities of daily living and/or everyday life, with the volunteers seated, in an ergonomic way and with the material used for the activities positioned on a table. The healthy UL will be restrained by the sling, while the paretic UL will perform the activities. The CIMT protocol will involve three main components: repetitive task-oriented training of the affected upper limb; the transfer package, developed to facilitate the generalization of therapeutic gains obtained in the clinical setting to the participant's daily activities; and the restriction of the unaffected upper limb, with the aim of inducing functional use of the affected limb, as described in the classic study by Taub et al. (2006). It is worth noting that the restraint of the unaffected limb will occur exclusively during the intervention period
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Transcranial direct current stimulation + Constraint-induced movement therapyExperimental treatment 2 interventions
Group B: Constraint-induced movement therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in upper limb motor function
Change in motor function measured by the Fugl-Meyer Assessment - Upper Extremity (FMA-UE). The FMA-UE assesses motor impairment of the upper extremity, with total scores ranging from 0 to 66 points. Higher scores indicate better upper extremity motor function, whereas lower scores indicate greater motor impairment.
Time frame
Baseline and 15 days after completion of the 18-session intervention protocol.Secondary outcomes
1
Secondary Outcome Measure: Muscle architecture assessed by musculoskeletal ultrasound
Changes in muscle architecture assessed by musculoskeletal ultrasound, including muscle thickness (cm), pennation angle (degrees), and echogenicity (arbitrary grayscale units). Higher muscle thickness values indicate greater muscle size. The pennation angle represents the angle between the muscle fascicles and the deep aponeurosis. Higher echogenicity values indicate greater intramuscular fat and/or connective tissue infiltration.
Time frame
Initial assessment and 15 days after completion of the 18-session intervention protocol.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov