Upper Limb Mirror Therapy with Bilateral Transcutaneous Electrical Nerve Stimulation to Improve Upper Limb Functions in Patients with Stroke

NCT03631628 | Recruiting

• 1 other identifier: 2019_MT_TENS_UL
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

This study compare the effectiveness of 2 rehabilitation programmes that use (1) MT with Bilateral TENS (Bi-TENS), (2) sham-MT with Bi-TENS (Bi-TENS), respectively, in addition to conventional rehabilitation of standardized upper limb training, in improving upper limb motor functions, activities of daily living, community integration, and quality of life in patients with stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (8)

• Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - baseline

  The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.

  Baseline (0 week)

• Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - midterm

  The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.

  4 weeks

• Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - post-training

  The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.

  8 weeks

• Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - followup

  The FMA-UE will be used to evaluate the severity of motor impairment in the paretic upper extremity. The performance of 33 tasks will be assessed using a three-point ordinal scale (0 to 2), with a maximum score of 66. The FMA-UE will assess voluntary movement, reflex activity, grasp, and coordination of the upper extremity, and has a high inter-rater reliability (r=0.99) in patients with stroke. A higher scale score indicates a less severe motor impairment.

  12 weeks

• Wolf Motor Function Test (WMFT) - baseline

  Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.

  Baseline (0 week)

• Wolf Motor Function Test (WMFT) - midterm

  Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.

  4 weeks

• Wolf Motor Function Test (WMFT) - post-training

  Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.

  8 weeks

• Wolf Motor Function Test (WMFT) - followup

  Upper limb function will be assessed by the WMFT, which comprises two items of strength-based tasks, and 15 items of function-based tasks. The two strength-based tasks will be measured by weight lift and grip strength. The 15 function-based tasks will be assessed by the time taken to complete each task (in seconds), and the quality rating of the use of the paretic hand in attempting each task (graded 0 to 5). The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score. The WMFT has a high inter-rater reliability (ICC=0.97) and test-retest reliability for time scores (ICC=0.95). A higher score indicates a better hand function.

  12 weeks

Secondary Outcomes (28)

• Grip Strength - baseline

  Baseline (0 week)

• Grip Strength - midterm

  4 weeks

• Grip Strength - post-training

  8 weeks

• Grip Strength - followup

  12 weeks

• Jacket Test - baseline

  Baseline (0 week)

Study Arms (2)

MT+ Bilateral TENS

EXPERIMENTAL

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.

Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS); Behavioral: Mirror Therapy (MT); Behavioral: Conventional Rehabilitation Program

sham-MT+ Bilateral TENS

PLACEBO COMPARATOR

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.

Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS); Behavioral: sham-Mirror Therapy (sham-MT); Behavioral: Conventional Rehabilitation Program

Interventions

Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS) DEVICE

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.

MT+ Bilateral TENS; sham-MT+ Bilateral TENS

Mirror Therapy (MT) BEHAVIORAL

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.

MT+ Bilateral TENS

sham-Mirror Therapy (sham-MT) BEHAVIORAL

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.

sham-MT+ Bilateral TENS

Conventional Rehabilitation Program BEHAVIORAL

Standardized upper limb training

MT+ Bilateral TENS; sham-MT+ Bilateral TENS

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have been diagnosed with ischemic brain injury or intracerebral hemorrhage by MRI or computed tomography within three weeks to 10 years after the first onset of stroke;
• have volitional control of the non-paretic arm, and at least minimal antigravity movement in the shoulder of the paretic arm;
• have at least 5 degrees in wrist extension of the paretic arm in the antigravity position
• are able to score \> 6 of 10 of abbreviated Mental Test;
• are able to follow instruction and give informed consent of the study.

You may not qualify if:

• Have any additional medical, cardiovascular and orthopedic condition that would hinder the proper assessment and treatment;
• Use cardiac pacemakers;
• Have receptive dysphasia;
• Have a significant upper limb peripheral neuropathy (e.g., diabetic polyneuropathy);
• Have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm;
• Have skin allergy that would prevent electrical stimulation;
• Are involved in drug studies or other clinical trials.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong, Hong Kong

RECRUITING

Shatin Hospital

Hong Kong, Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Shamay Ng, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shamay NG, PhD

CONTACT

+852 2766-4889; shamay.ng@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)