Clinical trial NCT03631628: Upper Limb Mirror Therapy with Bilateral Transcutaneous Electrical Nerve Stimulation to Improve Upper Limb Functions in Patients with Stroke
Official title: A Randomized Controlled Clinical Trial of Upper Limb Training with Mirror Therapy (MT) and Bilateral Transcutaneous Electrical Nerve Stimulation (Bi-TENS) to Improve Upper Limb Motor Functions in Patients with Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - baseline
timeFrame: Baseline (0 week)
measure: Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - midterm
timeFrame: 4 weeks
measure: Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - post-training
timeFrame: 8 weeks
measure: Fugl-Meyer Assessment of Upper Extremity (FMA-UE) - followup
timeFrame: 12 weeks
measure: Wolf Motor Function Test (WMFT) - baseline
timeFrame: Baseline (0 week)
measure: Wolf Motor Function Test (WMFT) - midterm
timeFrame: 4 weeks
measure: Wolf Motor Function Test (WMFT) - post-training
timeFrame: 8 weeks
measure: Wolf Motor Function Test (WMFT) - followup
timeFrame: 12 weeks
Secondary outcomes:
measure: Grip Strength - baseline
timeFrame: Baseline (0 week)
measure: Grip Strength - midterm
timeFrame: 4 weeks
measure: Grip Strength - post-training
timeFrame: 8 weeks
measure: Grip Strength - followup
timeFrame: 12 weeks
measure: Jacket Test - baseline
timeFrame: Baseline (0 week)
measure: Jacket Test - midterm
timeFrame: 4 weeks
measure: Jacket Test - post-training
timeFrame: 8 weeks
measure: Jacket Test - followup
timeFrame: 12 weeks
measure: Upper Extremity Functional Index (UEFI) - baseline
timeFrame: Baseline (0 week)
measure: Upper Extremity Functional Index (UEFI) - midterm
timeFrame: 4 weeks
measure: Upper Extremity Functional Index (UEFI) - post-training
timeFrame: 8 weeks
measure: Upper Extremity Functional Index (UEFI) - followup
timeFrame: 12 weeks
measure: Motor Activity Log (MAL) - baseline
timeFrame: Baseline (0 week)
measure: Motor Activity Log (MAL) - midterm
timeFrame: 4 weeks
measure: Motor Activity Log (MAL) - post-training
timeFrame: 8 weeks
measure: - Motor Activity Log (MAL) - followup
timeFrame: 12 weeks
measure: Stroke Impact Scale (SIS) - baseline
timeFrame: Baseline (0 week)
measure: Stroke Impact Scale (SIS) - midterm
timeFrame: 4 weeks
measure: Stroke Impact Scale (SIS) - post-training
timeFrame: 8 weeks
measure: Stroke Impact Scale (SIS) - followup
timeFrame: 12 weeks
measure: Community Integration Questionnaire (CIM) - baseline
timeFrame: Baseline (0 week)
measure: Community Integration Questionnaire (CIM) - midterm
timeFrame: 4 weeks
measure: Community Integration Questionnaire (CIM) - post-training
timeFrame: 8 weeks
measure: Community Integration Questionnaire (CIM) - followup
timeFrame: 12 weeks
measure: SATIS-Stroke - baseline
timeFrame: Baseline (0 week)
measure: SATIS-Stroke - midterm
timeFrame: 4 weeks
measure: SATIS-Stroke- post-training
timeFrame: 8 weeks
measure: SATIS-Stroke - followup
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
city: Hong Kong
country: Hong Kong
facility: Shatin Hospital
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Shamay Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: