Trials / Unknown
UnknownNCT03631628
Upper Limb Mirror Therapy with Bilateral Transcutaneous Electrical Nerve Stimulation to Improve Upper Limb Functions in Patients with Stroke
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- The Hong Kong Polytechnic University · Academic / Other
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| BEHAVIORAL | 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. |
| BEHAVIORAL | 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. |
| BEHAVIORAL | Conventional Rehabilitation Program | Standardized upper limb training |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2018-08-15
- Last updated
- 2024-10-03
Locations
2 sites across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT03631628. Inclusion in this directory is not an endorsement.