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NCT Number: NCT06463795

tDCS and Lower Limb Performance in Stroke

Lower limb rehabilitation is especially important, as the simple act of regaining the ability to walk has subsequent effects on the ability to engage in activities of daily living .So, this study will contribute in describing the management of lower limb motor recovery along with the therapeutic intervention (MRP) with tDCS (anodal stimulation). This study aims to address some of the drawbacks observed in previous studies like allocation concealment, small sample size due to drop outs, short term effects of tDCS and experimental designs as well.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

About this study

Transcranial Direct Current Stimulation (tDCS) appears to be an intriguing adjuvant for stroke neurorehabilitation, though there are many other methods available. Depending on the polarity used, tDCS alters cortical excitability when electrodes applied over the motor cortex area (M1) to be stimulated, and the cathode above the contralateral eye (Orbital area), tDCS (thus termed anodal) increases cortical excitability. It is easy to use, safe and has minimal side effects like a sensation of itching, post-stimulation headache and sometimes mild nausea may experience. Numerous research indicates that cortical activity rises in conjunction with gait. According to a number of studies, corticospinal neuron activity either parallels or possibly even partially regulates the activity of spinal motor neurons during walking. There exist various techniques for implementing transcranial direct current stimulation in conjunction with multiple supplementary therapies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stroke for more than 6 months.
  • National Institutes of Health Stroke Scale (NIHSS) for severity level (Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)

Exclusion criteria

  • Epilepsy
  • Scalp injury/ skin lesion e.g. psoriasis or eczema etc.
  • Patient with lower limb amputation or any MSK/neurological disorder that limit the LE function
  • Implanted medical devices including intracranial electrodes, surgical clips, shrapnel or a pacemaker

Treatment and study plan

tDCS

Device

active anodal tDCS

Sham tDCS

Device

sham anodal tDCS

Primary outcomes

  1. FMA-lower extremity

    Time frame: 8 week

    FMA-LE is a method used to measure motor function, balance, and function of joints in post-stroke patients. Fugl Meyer Assessment of Lower Extremity (FMA-LE). FMA-LE is a method used to evaluate the performance of motor movement on the lower limbs (hips, knees, feet, and ankles) and predicts recovery function of motion in stroke patients. FMA-LE method consists of 17 items are organized into several sub-sections, namely reflection part, synergistic part, and coordination with Mild (˃45),Moderate (30-45),Severe (˂30) scores(12). It shows sensitivity of 0.87 and specificity of 0.81

  2. Six Minute walk Test

    Time frame: 8 week

    The Six-Minute Walk Test (6MWT) is a functional walking test in which the distance that a stroke patient can walk within six minutes is evaluated. This test has been used to assess individuals with stroke, head injury and Parkinson's disease. There are no actual items to the 6MWT.It is a simple test that requires a 100-ft, quiet, indoor, flat, straight rectangular hallway. The walking course must be 30m in length. The length of the 30m corridor must be marked by colored tape at every 3m. The turnaround must be marked with a cone. Some studies have used 20 and 50m corridors. It has excellent test-retest reliability (0.99 distance in meters) among stroke survivors

Secondary outcomes

  1. Stroke Specific Quality of Life

    Time frame: 8 week

    The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. It is a self-report scale containing 49 items in 12 domains including Energy, Mobility, Upper extremity function, Work/productivity, Mood, Self-care, Social roles, Family roles, Vision, Language, Thinking, and Personality. Score ranges from 49 to 245. Higher scores indicate better QOL(14).It has a sensitivity of 70.0% and a specificity of 75.8%

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Transcranial Direct Current Stimulation on Lower Limb Performance in Stroke Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 18, 2024
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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