A Randomized Controlled Trial of Anodal Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation for Improving Lower Limb Function in Stroke Patients

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS) in augmenting the efficacy of the lower limb task-oriented training in people with stroke. It is hypothesize that lower limb motor function can be best improved by combining anodal tDCS with TENS, when compared with sham-tDCS with TENS, anodal tDCS with placebo-TENS, or control training at improving ankle muscle strength, motor control of lower limbs, walking performance, functional mobility and community integration in people with stroke.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• are between 50 and 85 years of age;

• have had a single stroke more than 6 months and less than 15 years;

• have at least 5 degrees of active ankle dorsiflexion in the antigravity position;

• are able to walk 10 m independently, with or without a walking aid;

• are able to score 6 or higher out of 10 on the abbreviated mental test;

• have no skin allergies (e.g. redness or itchiness after application of the electrical stimulation pads) to electrical stimulation or electrodes;

• are able to follow instructions and give informed consent.

Locations
Other Locations
Hong Kong Special Administrative Region
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Contact Information
Primary
Shamay NG, PhD
shamay.ng@polyu.edu.hk
+852 27664889
Time Frame
Start Date: 2024-06-17
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 92
Treatments
Experimental: Anodal tDCS+Bi-TENS
All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks.
Sham_comparator: Sham-tDCS+Bi-TENS
All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks.
Placebo_comparator: Anodal tDCS+placebo-TENS
All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks.
Placebo_comparator: Control training
All subjects will receive eighteen 60-minute sessions of intervention, 3 sessions per week for 6 weeks.
Related Therapeutic Areas
Sponsors
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov