NCT07200661

Transcranial Direct Current Stimulation, Functional Activity, Stroke, RCT

The Effects of Transcranial Direct Current Stimulation on Improving Impairment and Functional Activity in Individuals With Stroke: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Phayao · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

Stroke patients often experience impaired balance and weight-bearing due to muscle weakness and neurological deficits. Motor rehabilitation is a crucial goal in their recovery, and transcranial direct current stimulation (tDCS) has emerged as a promising therapeutic approach. When combined with motor training, tDCS can enhance walking and balance abilities. However, there is a lack of research exploring the combination of unstable surfaces training, cognitive function, and tDCS for stroke rehabilitation

Detailed description

Stroke is a leading cause of long-term disability worldwide, often resulting in impaired motor function, reduced walking ability, decreased muscle strength, and cognitive deficits. These limitations contribute to difficulties in activities of daily living, impaired balance, and reduced quality of life. Effective rehabilitation strategies are essential to promote functional recovery and reduce the risk of long-term dependence. Transcranial direct current stimulation (tDCS) has emerged as a promising non-invasive neuromodulation technique to facilitate cortical excitability and enhance neuroplasticity in individuals with stroke. Anodal stimulation over the lesioned hemisphere has been shown to improve motor performance and cognitive processing, while sham stimulation does not induce comparable effects. Recent studies suggest that combining tDCS with task-specific rehabilitation programs may provide synergistic benefits by simultaneously enhancing neural activation and functional task performance. Dual-task training, particularly stepping exercises performed on unstable surfaces, has been demonstrated to challenge both motor and cognitive systems simultaneously. This approach targets balance, gait adaptation, and executive function by requiring patients to divide attention between locomotion and cognitive demands. When applied in combination with tDCS, dual-task training may enhance neuroplasticity and strengthen functional outcomes beyond those achieved by conventional training alone. The present randomized controlled trial is designed to investigate the combined effects of anodal tDCS and dual-task stepping exercise on unstable surfaces in stroke survivors. Participants will be randomized into three groups: (1) active tDCS combined with dual-task stepping, (2) dual-task stepping with sham tDCS, and (3) active tDCS alone. Interventions will be delivered three times per week for four weeks. Primary outcomes will include measures of functional ability, walking speed, walking endurance, lower limb muscle strength, and cognitive ability. Secondary outcomes will explore the effects of combined stimulation on balance and overall motor recovery. It is hypothesized that participants receiving combined anodal tDCS and dual-task training will demonstrate greater improvements in both motor and cognitive outcomes compared with either intervention alone. This study will contribute novel evidence to stroke rehabilitation research by addressing the knowledge gap regarding the integration of non-invasive brain stimulation with cognitive-motor dual-task training on unstable surfaces. The findings are expected to provide insights into effective multimodal rehabilitation strategies aimed at improving functional recovery and quality of life in stroke survivors.

Conditions

• Ischemic Stroke
• Hemorrhagic Stroke
• Stroke, Cardiovascular

Interventions

Type	Name	Description
DEVICE	Experimental A tDCS: Transcranial direct current stimulation.	Group 1: Active tDCS combined with dual-task stepping (Experimental A) Participants in this group will receive anodal tDCS applied over the ipsilesional primary motor cortex (M1) at C3 or C4 (based on the 10-20 EEG system), with the reference electrode positioned over the contralesional supraorbital area. Stimulation will be delivered at an intensity of 2 mA for 20 minutes, During the stimulation period, participants will perform dual-task stepping exercises on unstable surfaces. The stepping program stepping on a foam pad (5 cm thick, 20 cm wide, 12 cm long). Each stepping session lasts 10 minutes and is immediately followed by overground walking at a comfortable speed for 10 meters, while simultaneously performing a cognitive task of counting backwards from 99 to 0. Participants are instructed not to pause or stop while performing the dual task. If they stop for more than 5 seconds, it is considered an error, which will be recorded.
DEVICE	Experimental B tDCS: Transcranial direct current stimulation.	Group 2:This group follows the same stepping and dual-task walking program as Group 1 (stepping on foam pad for 10 minutes, followed by overground walking with backward counting for 10 minutes). However, instead of active stimulation, participants receive sham tDCS.
DEVICE	Experimental C tDCS: Transcranial direct current stimulation.	Group 3:Participants in this group will receive anodal tDCS only, without any dual-task or stepping training.

Timeline

• Start date: 2024-04-20
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2025-10-01
• Last updated: 2025-10-01

Locations

3 sites across 1 country: Thailand