tDCS and Lower Limb Performance in Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463795
• Other study ID #: REC01898 Saira Muzaffar Shah
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Saira Muzaffar Shah, DPT
• Phone: 00923035708980
• Email: sayeda.saira110[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• tDCS
active anodal tDCS
• Sham tDCS
sham anodal tDCS

Locations

Country	Name	City	State
Pakistan	Pakistan Railway General Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Bai X, Guo Z, He L, Ren L, McClure MA, Mu Q. Different Therapeutic Effects of Transcranial Direct Current Stimulation on Upper and Lower Limb Recovery of Stroke Patients with Motor Dysfunction: A Meta-Analysis. Neural Plast. 2019 Nov 16;2019:1372138. doi: 10.1155/2019/1372138. eCollection 2019. — View Citation

Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2. — View Citation

Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FMA-lower extremity	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	8 week
Primary	Six Minute walk Test	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	8 week
Secondary	Stroke Specific Quality of Life	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%	8 week