Efficacy of Cerebello-spinal Direct Current Stimulation (csDCS) on Functional Mobility in Chronic Stroke Patients

Not Applicable

Recruiting

• Conditions: Stroke Rehabilitation; Gait Disorders, Neurologic; tDCS

• Registration Number: NCT07073287
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-01
• Study First Submitted: 2025-06-18
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Primary Completion: 2026-01-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Confirmation of Stroke by digital or physical imaging or medical report
• Gait impairment
• Stroke with at least 6 months after ictus

Exclusion Criteria

• Metallic implants in spinal cord
• Major orthopedic/rheumatological disorders
• Inability of verbal or non-verbal communication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Mobility	Baseline, post-treatment (2 weeks) and follow up after 30 days	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.

Secondary Outcome Measures

Name	Time	Method
Independency level	Baseline, post-treatment (2 weeks) and follow up after 30 days	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).
Lower limb motor function	Baseline, post-treatment (2 weeks) and follow up after 30 days	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).
Balance	Baseline, post-treatment (2 weeks) and follow up after 30 days	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.
Perceived change in treatment	Upon completion of the two-week intervention	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.
Spasticity	Baseline, post-treatment (2 weeks) and follow up after 30 days	Muscle tone disorders will be assessed using the Modified Ashworth Scale, which measures spasticity by grading muscle resistance during passive stretching. The scale ranges from 0 to 4, where 0 indicates no increase in muscle tone, and 4 represents a limb that is rigid in flexion or extension.

Trial Locations

Locations (3)

Federal University of Paraiba; 🇧🇷 João Pessoa, Paraíba, Brazil

Federal University of Pernambuco; 🇧🇷 Recife, PE, Brazil

Federal University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil