Combining electrical stimulation techniques to improve lower limb function in stroke patients
A Randomized Controlled Trial of Anodal Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation for Improving Lower Limb Function in Stroke Patients
This study is testing if combining two types of electrical stimulation can help stroke patients improve their leg strength and walking ability during rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06838013 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS) to enhance lower limb motor function in individuals who have experienced a stroke. Participants will undergo task-oriented training while receiving either active or sham stimulation to determine the best approach for improving ankle muscle strength, motor control, walking performance, and overall mobility. The study hypothesizes that the combination of anodal tDCS and Bi-TENS will yield superior results compared to other stimulation methods. The research aims to explore the potential synergetic effects of these interventions on rehabilitation outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 85 who have experienced a single stroke more than 6 months and less than 15 years ago and can walk independently.
Not a fit: Patients with additional medical conditions, cognitive difficulties, or those who have had recent seizures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes and improve mobility for stroke patients.
How similar studies have performed: While the combination of tDCS and TENS is a novel approach, previous studies have shown promising results with similar electrical stimulation techniques in enhancing motor function.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. are between 50 and 85 years of age; 2. have had a single stroke more than 6 months and less than 15 years; 3. have at least 5 degrees of active ankle dorsiflexion in the antigravity position; 4. are able to walk 10 m independently, with or without a walking aid; 5. are able to score 6 or higher out of 10 on the abbreviated mental test; 6. have no skin allergies (e.g. redness or itchiness after application of the electrical stimulation pads) to electrical stimulation or electrodes; 7. are able to follow instructions and give informed consent. Exclusion Criteria: 1. have any additional medical, cardiovascular or orthopedic conditions that would hinder their treatment or assessment; 2. have a cardiac pacemaker; 3. have aphasia or cognitive difficulties that may interfere with their comprehension of instructions; 4. have had one or more epileptic seizures within the year prior to the date of inclusion in the study; 5. have an intracerebral metal clip; 6. have a major somatosensory deficit 7. have any contraindication to tDCS; 8. are currently involved in drug studies or other clinical trials.
Where this trial is running
Hong Kong
- The Hong Kong Polytechnic University — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Shamay Ng, PhD — The Hong Kong Polytechnic University
- Study coordinator: Shamay NG, PhD
- Email: shamay.ng@polyu.edu.hk
- Phone: +852 27664889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.