Efficacy of Cerebello-spinal Direct Current Stimulation (csDCS) on Functional Mobility in Chronic Stroke Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversidade Federal de Pernambuco
About this trial
The aim of this clinical trial is to determine if cerebello-spinal direct current stimulation (csDCS) is effective in treating gait disorders in individuals with chronic stroke. Additionally, the trial seeks to evaluate the safety of this technique.
The primary objectives include:
Investigating whether cerebello-spinal direct current stimulation improves gait and functional mobility in participants with chronic stroke.
Assessing any potential side effects associated with the method.
Researchers will conduct a comparative analysis between cerebello-spinal direct current stimulation and a sham procedure (which mimics the stimulation without any actual effect) to assess its effectiveness in addressing gait disorders and enhancing mobility.
Participants in the trial will:
Undergo cerebello-spinal direct current stimulation combined with treadmill training or a sham procedure with treadmill training daily over a two-week period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmation of Stroke by digital or physical imaging or medical report
Gait impairment
Stroke with at least 6 months after ictus
Disqualifiers
Metallic implants in spinal cord
Major orthopedic/rheumatological disorders
Inability of verbal or non-verbal communication
Trial design
Design model
Parallel
Treatments tested in this trial
Cerebello-spinal direct current stimulation
DevicecsDCS influences both ascending and descending spinal pathways and reflex excitability, promoting prolonged functional neuroplastic changes.
Sham Comparator
DeviceMasking for cerebello-spinal direct current stimulation involves the electric current stopping after 30 seconds, providing a sensation without producing neuromodulation.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Active cerebello-spinal direct current stimulationExperimental treatment 1 intervention
Group B: Sham cerebello-spinal direct current stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Functional Mobility
The Timed-Up and Go (TUG) test is used to evaluate an individual´s capacity to stand up, walk, and sit down. During the test, the participants are timed from the moment they begin to stand up until they are seated again.
Time frame
Baseline, post-treatment (2 weeks) and follow up after 30 daysSecondary outcomes
1
Independency level
Self-reported independence is assessed using the Functional Ambulation Categories (FAC). Scores range from 0 (inability to walk even with external help) to 5 (normal ambulation).
Time frame
Baseline, post-treatment (2 weeks) and follow up after 30 days2
Lower limb motor function
Motor function of the lower limbs is assessed using the Fugl-Meyer Assessment, where scores range from 0 (indicating the worst motor function) to 28 (indicating normal motor function).
Time frame
Baseline, post-treatment (2 weeks) and follow up after 30 days3
Balance
Capacity to maintain balance during various tasks is assessed using the Mini Balance Evaluation System (MiniBEST-test). Its scores range from 0 to 28 points. Lower scores indicate poor balance, while higher scores reflect better balance.
Time frame
Baseline, post-treatment (2 weeks) and follow up after 30 days4
Perceived change in treatment
Evaluation of how the participant describe the perceived change in their condition since the treatment started, using the Patient Global Impression of Change (PGM). This scale assesses the change in activity limitations, symptoms, emotions, and overall quality of life since the beginning of treatment, ranging from no change or worsening to significant improvement that made a considerable difference. A score of one indicates no change, while a score of seven represents a substantial improvement.
Time frame
Upon completion of the two-week interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidade Federal de Pernambuco
Lead sponsor
Universidade Federal do Rio de Janeiro
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Source ClinicalTrials.gov