Stroke
Conditions
Brief summary
The purpose of this study is to investigate the clinical efficacy and neurological progress of combined training using trans-spinal electrical stimulation (tsES) and neuromuscular electrical stimulation (NMES)-driven robotics on upper limb rehabilitation after stroke
Detailed description
This study aims to explore whether a multimodal intervention that combines central neuromodulation through trans-spinal electrical stimulation (tsES), peripheral activation via neuromuscular electrical stimulation (NMES), and task-specific robotic training can enhance upper limb recovery. Specific objectives: 1. To evaluate the clinical efficacy of combining tsES and NMES robotic training for enhancing upper limb motor function in post-stroke patients. 2. To quantify the neurological progress of the tsES and NMES robot combined interventions in the rehabilitation process using electrophysiological tracers (electroencephalogram, electromyogram) and kinesiological recorder (Inertial Measurement Unit) 3. To investigate the central-to-peripheral neuroplasticity by corticomuscular coherence evaluation in poststroke rehabilitation
Interventions
The recruited subjects will receive 20 sessions of robot-assisted upper limb training combined with central-to-peripheral electrical stimulation, delivered at a frequency of 3 to 5 sessions per week, which will be completed within 4 to 7 consecutive weeks. Each rehabilitation session will begin with a 10-minute preparation phase, followed by 20 minutes of NMES and tsES-assisted robotic training. After a 10-minute break, the session will continue with an additional 20 minutes of robotic-assisted training combined with NMES alone, with tsES turned off during this phase. During the training, patients will perform repeated wrist and finger flexion-extension tasks. The training protocol is designed to activate wrist extension voluntarily (exceeding 10% of their initial MVC), which then triggers NMES and inflation of the robotic hand to assist finger opening.
BEHAVIORALOccupational Therapy with Electrical Stimulation
The recruited subjects will receive 20 sessions of task-oriented occupational therapy(OT) combined with trans-spinal electrical stimulation(tsES), delivered at a frequency of 3 to 5 sessions per week, which will be completed within 4 to 7 consecutive weeks. Each rehabilitation session will begin with a 10-minute preparation phase, followed by 20 minutes of OT training with tsES. After a 10-minute break, the session will continue with an additional 20 minutes of COT alone, with tsES turned off during this phase. During the OT training, the stroke participants will perform functional daily living tasks, including cylindrical grasp, disc grasp, and tip pinch.
BEHAVIORALoccupational therapy with sham electrical stimulation
The recruited subjects will receive 20 sessions of task-oriented occupational therapy(OT) combined with sham trans-spinal electrical stimulation(tsES), delivered at a frequency of 3 to 5 sessions per week, which will be completed within 4 to 7 consecutive weeks. Each rehabilitation session will begin with a 10-minute preparation phase, followed by 20 minutes of OT training with 0mA-intensity tsES. After a 10-minute break, the session will continue with an additional 20 minutes of COT alone, with tsES turned off during this phase. During the training, the stroke participants will repeatedly practice functional daily living tasks, including cylindrical grasp, disc grasp, and tip pinch.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects in the chronic stage (start from 6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic); * Sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score\>23); * Be able to sit up for 60 minutes (with or without assistance); * Muscle strength graded from 1 to 3 in biceps brachii, triceps brachii, extensor carpi radialis, flexor carpi radialis, and abductor pollicis brevis in the affected side. * The voluntary electromyographic signals of the wrist extensor and wrist flexor muscle groups can be detected.
Exclusion criteria
* Patients with secondary stroke; * Severe dysphasia (either expressive or comprehensive) with inadequate communication; * Any additional medical or psychological condition affecting their ability to comply with the study protocol; * History of other neurological disease, psychiatric disorder, including alcoholism and substance abuse; * currently pregnant; * epilepsy; * pacemaker implantation or deep brain stimulation; * involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb; * skin disease at the area of the electrodes; * High hypertension and cannot maintain normal blood pressure despite daily intake of antihypertensive medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl-Meyer Assessment Scale after training | Within 1 week before the start of training Within 1 week after the completion of training 3 months after the completion of training | The Fugl-Meyer Assessment (FMA) Scale for the upper limb measures voluntary motor function in the shoulder, wrist, and hand. The total score ranges from 0 to 66, with higher scores indicating better motor function. The scale can be further divided into two subscores: shoulder/elbow (0-42) and wrist/hand (0-24). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Ashworth Scale(MAS), Action Research Arm Test (ARAT), Wolf Motor Function Test (WMFT) after training | Within 1 week before the start of training Within 1 week after the completion of training 3 months after the completion of training | The Modified Ashworth Scale (MAS) assesses muscle spasticity by measuring resistance during passive joint movement, particularly in the flexor muscles. The MAS consists of six levels, ranging from 0 to 4 (with an additional grade of 1+), where higher scores indicate increased resistance and greater muscle spasticity. The Action Research Arm Test (ARAT) evaluates upper limb motor function by measuring the ability to perform specific tasks related to grasp, grip, pinch, and gross movement. It consists of 19 items, each scored from 0 to 3, with a total score ranging from 0 to 57. Higher scores represent better upper limb functional performance. The Wolf Motor Function Test (WMFT) assesses upper extremity motor ability through a series of timed and functional tasks. It includes 15 function-based items and 2 strength-based items. Each task is timed and rated on a 6-point functional ability scale, where higher scores and faster completion times reflect better motor performance. |
| Change in Cortico-Muscular Coherence (CMC) after training | Within 1 week before the start of training Within 1 week after the completion of training 3 months after the completion of training | Cortico-Muscular Coherence (CMC) is calculated using simultaneous EEG and EMG recordings to assess the functional connectivity between the motor cortex and the target muscle. |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORXiaoling HU
The Hong Kong Polyterchnic University
Outcome results
None listed