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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03631628

2019_MT_TENS_UL

Details and patient eligibility

About

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.

Full description

The principal aim of the proposed study will be to demonstrate whether MT with Bi-TENS is more effective than 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.

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
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

1. Have any additional medical, cardiovascular and orthopedic condition that would hinder the proper assessment and treatment;
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups, including a placebo group

MT+ Bilateral TENS

Experimental group

Description:

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.

Treatment:

Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS)

Behavioral: Conventional Rehabilitation Program

Behavioral: Mirror Therapy (MT)

sham-MT+ Bilateral TENS

Placebo Comparator group

Description:

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.

Treatment:

Device: Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS)

Behavioral: Conventional Rehabilitation Program

Behavioral: sham-Mirror Therapy (sham-MT)