Upper Limb Mirror Therapy with Bilateral Transcutaneous Electrical Nerve Stimulation to Improve Upper Limb Functions in Patients with Stroke
NCT ID: NCT03631628
Last Updated: 2024-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
90 participants
INTERVENTIONAL
2021-01-01
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Mirror Therapy with Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in Stroke
NCT03622879
Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke
NCT03112473
Effects of Mirror Therapy and Bilateral Arm Training on Hemiparetic Upper Extremity in Patients With Chronic Stroke
NCT04242316
Robot-assisted Therapy Combined With Mirror Priming in Upper Limb Training in Stroke
NCT04326140
Neural Mechanisms and Efficacy of Dual Neurotechnology-aided Mirror Therapy in Chronic Stroke: Neural and Motor Plasticity, Movement Performance, Daily Function, and Quality of Life
NCT04326205
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The null hypothesis will be that MT with Bi-TENS is not significantly different from sham-MT with Bi-TENS in improving upper limb motor functions, activities of daily living, community integration, and quality of life in patients with stroke.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MT+ Bilateral TENS
All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of MT+bilateral TENS and 1 hour conventional training of standardized upper limb training.
Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS)
The stimulator is a 120z Dual-Channel TENS Unit (ITO Physiotherapy \& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching, to provide sensory stimulation to both paretic and intact arms. Two pairs of disposable surface electrodes will be applied over the median nerve from the carpal tunnel to the flexor digitorum superficialis and the superficial radial nerve from the extensor pollicis longus to the extensor digitorum communis, with the cathode on the proximal site, and the anode on the distal site.
Mirror Therapy (MT)
A customised angle-adjustable frame with a mirror board will be used. All subjects are instructed to perform
1. Elbow flexion and extension exercise
2. Forearm pronation and supination exercise
3. Wrist flexion and extension exercise
4. Wrist radial and ulnar deviation exercise
5. Fingers opposition exercise
6. Gripping exercise
The subject will complete bilaterally upper limb exercises during the 30 minutes period.
Intact arm will be placed in front of mirror, and paretic arm will be placed behind the mirror.
Joints involved will be flexed and extended in full available range in sitting positon, in order to improve the active control of elbow joint, wrist joint and all fingers joint respectively.
Participants will be encouraged to focus on the image of intact arm when performing upper limb exercises bilaterally.
Conventional Rehabilitation Program
Standardized upper limb training
sham-MT+ Bilateral TENS
All subjects will undergo 16 sessions of treatment (2 times per week, for 8 weeks). Subjects will receive 1.5 hours rehabilitation program: 30 minutes of sham-MT+bilateral TENS and 1 hour conventional training of standardized upper limb training.
Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS)
The stimulator is a 120z Dual-Channel TENS Unit (ITO Physiotherapy \& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching, to provide sensory stimulation to both paretic and intact arms. Two pairs of disposable surface electrodes will be applied over the median nerve from the carpal tunnel to the flexor digitorum superficialis and the superficial radial nerve from the extensor pollicis longus to the extensor digitorum communis, with the cathode on the proximal site, and the anode on the distal site.
sham-Mirror Therapy (sham-MT)
A customised angle-adjustable frame with a mirror board will be used while the reflecting surface of the mirror was covered with paper. All subjects are instructed to perform
1. Elbow flexion and extension exercise
2. Forearm pronation and supination exercise
3. Wrist flexion and extension exercise
4. Wrist radial and ulnar deviation exercise
5. Fingers opposition exercise
6. Gripping exercise
The subject will complete bilaterally upper limb exercises during the 30 minutes period.
Intact arm will be placed in front of covered mirror, and paretic arm will be placed behind the covered mirror.
Joints involved will be flexed and extended in full available range in sitting positon, in order to improve the active control of elbow joint, wrist joint and all fingers joint respectively.
Conventional Rehabilitation Program
Standardized upper limb training
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS)
The stimulator is a 120z Dual-Channel TENS Unit (ITO Physiotherapy \& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching, to provide sensory stimulation to both paretic and intact arms. Two pairs of disposable surface electrodes will be applied over the median nerve from the carpal tunnel to the flexor digitorum superficialis and the superficial radial nerve from the extensor pollicis longus to the extensor digitorum communis, with the cathode on the proximal site, and the anode on the distal site.
Mirror Therapy (MT)
A customised angle-adjustable frame with a mirror board will be used. All subjects are instructed to perform
1. Elbow flexion and extension exercise
2. Forearm pronation and supination exercise
3. Wrist flexion and extension exercise
4. Wrist radial and ulnar deviation exercise
5. Fingers opposition exercise
6. Gripping exercise
The subject will complete bilaterally upper limb exercises during the 30 minutes period.
Intact arm will be placed in front of mirror, and paretic arm will be placed behind the mirror.
Joints involved will be flexed and extended in full available range in sitting positon, in order to improve the active control of elbow joint, wrist joint and all fingers joint respectively.
Participants will be encouraged to focus on the image of intact arm when performing upper limb exercises bilaterally.
sham-Mirror Therapy (sham-MT)
A customised angle-adjustable frame with a mirror board will be used while the reflecting surface of the mirror was covered with paper. All subjects are instructed to perform
1. Elbow flexion and extension exercise
2. Forearm pronation and supination exercise
3. Wrist flexion and extension exercise
4. Wrist radial and ulnar deviation exercise
5. Fingers opposition exercise
6. Gripping exercise
The subject will complete bilaterally upper limb exercises during the 30 minutes period.
Intact arm will be placed in front of covered mirror, and paretic arm will be placed behind the covered mirror.
Joints involved will be flexed and extended in full available range in sitting positon, in order to improve the active control of elbow joint, wrist joint and all fingers joint respectively.
Conventional Rehabilitation Program
Standardized upper limb training
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. have volitional control of the non-paretic arm, and at least minimal antigravity movement in the shoulder of the paretic arm;
3. have at least 5 degrees in wrist extension of the paretic arm in the antigravity position
4. are able to score \> 6 of 10 of abbreviated Mental Test;
5. are able to follow instruction and give informed consent of the study.
Exclusion Criteria
2. Use cardiac pacemakers;
3. Have receptive dysphasia;
4. Have a significant upper limb peripheral neuropathy (e.g., diabetic polyneuropathy);
5. Have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm;
6. Have skin allergy that would prevent electrical stimulation;
7. Are involved in drug studies or other clinical trials.
50 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Hong Kong Polytechnic University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shamay Ng
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shamay Ng, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Hong Kong Polytechnic University
Hong Kong, Hong Kong, Hong Kong
Shatin Hospital
Hong Kong, Hong Kong, Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Shamay SM Ng, PhD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019_MT_TENS_UL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.