tDCS with Constraint Therapy for better arm movement after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, blinded trial, participants with chronic upper-limb weakness after stroke will receive either transcranial direct current stimulation plus constraint-induced movement therapy or constraint therapy alone over six weeks (18 sessions). The goal is to see if the combination improves motor function and also changes muscle function and muscle activity. Eligible adults aged 40–80 with mild-to-moderate impairment will be recruited from Belém, Pará, using a convenience sample of about 40 participants. Assessments include Fugl-Meyer Upper Extremity scores and other motor evaluations at multiple time points.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria: - 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.

Where it's running

• State University of Pará - Center for Biological and Health Sciences (UEPA)
  Belém, Pará, Brazil Recruiting
• UEAFTO - Unidade de Fisioterapia e Terapia Ocupacional
  Belém, Pará, Brazil Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.