Actively Recruiting
Efficacy of Cerebello-spinal Direct Current Stimulation on Functional Mobility in Chronic Stroke Patients
Led by Universidade Federal de Pernambuco · Updated on 2025-07-18
30
Participants Needed
3
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
Universidade Federal de Pernambuco
Lead Sponsor
U
Universidade Federal do Rio de Janeiro
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether cerebello-spinal direct current stimulation (csDCS) can improve walking ability and overall mobility in people who have chronic stroke-related gait disorders. The study also investigates the safety of this stimulation method by comparing its effects to a sham procedure, which mimics stimulation without actual impact. The trial is a phase 2 clinical study focused on stroke rehabilitation and functional mobility enhancement. Participants will receive either active csDCS or sham csDCS combined with treadmill training daily for two weeks. The csDCS device influences spinal pathways and reflex excitability to promote lasting neuroplastic changes. The sham procedure involves stopping the current after 30 seconds to create a sensation without neuromodulation. Both groups will undergo treadmill training alongside their assigned intervention. Participants will be assessed on their functional mobility before treatment, immediately after the two-week intervention, and again at a 30-day follow-up. Researchers will also measure independence level, lower limb motor function, balance, perceived changes from treatment, and spasticity at these same time points. The study uses a randomized, double-blind design to monitor outcomes and side effects during and after treatment, with total participation lasting about one month.
CONDITIONS
Brief Title
Efficacy of Cerebello-spinal Direct Current Stimulation (csDCS) on Functional Mobility in Chronic Stroke Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmation of stroke by digital or physical imaging or medical report
- Presence of gait impairment
- Stroke occurred at least 6 months prior to enrollment
- Age between 18 and 75 years
You will not qualify if you...
- Presence of metallic implants in the spinal cord
- Major orthopedic or rheumatological disorders
- Inability to communicate verbally or non-verbally
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive cerebello-spinal direct current stimulation or sham stimulation alongside treadmill training to assess effects on functional mobility.
Daily visits during the 2-week intervention period
Duration - 30 days
Participants are monitored to assess the lasting effects of the stimulation on mobility and related functions.
1 visit (in-person) approximately 30 days after treatment completion
Trial Site Locations
Total: 3 locations
1
Federal University of Paraiba
João Pessoa, Paraíba, Brazil, 58051-900
Actively Recruiting
2
Federal University of Pernambuco
Recife, Pernambuco, Brazil, 50670-420
Actively Recruiting
3
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil, 23510-220
Actively Recruiting
Research Team
D
DANIEL MELO, Bachelor in physical therapy
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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