the current study is a Blinded Randomised Controlled Trial investing the effectiveness of Combining Transcutaneous Vagus Nerve Stimulation with Peripheral Nerve Stimulation on Upper Limb Motor Function in People with Stroke
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
The left cymba conchae was selected as taVNS stimulation side. The taVNS was delivered by earphone-shaped stimulators for 30 minutes with the stimulation parameters as follows: 0.3-ms square pulses at 20 Hz for 30 seconds with a duty cycle of 1:1; and the intensity of the stimulation was individually adjusted according to the tolerance of participants
The sham stimulation will be delivered with a shame model of the same device that used in the taVNS intervention. The interference of the device will display that the device is working normally while no electrical current output.
The Hong Kong Polytechnic University
Kowloon, Hong Kong
RECRUITINGFugl-Meyer assessment of upper extremity (FMA-UE)
The FMA-UE was used to assess motor impairment. It includes 33 items assessing movement, coordination, and reflex actions of the shoulder, elbow, forearm, wrist, and hand joints of the paretic arm. Each item consists of a 3-point scale (0, 1, and 2), with a total maximum score of 66.
Time frame: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).
Chinese version of brief memory and executive test (BMET)
The Chinese version of BMET will be used to assess cognitive function. It incorporates tests divided into two main categories: i) executive functioning and processing speed; and ii) orientation and memory. The initial performance of each item is converted to item score (0-2) and the total score (0-16) was used for statistical analysis, where a higher score indicates better general cognitive function.
Time frame: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).
Jacket test
The jacket test will be used to assess the upper limb proficiency in putting on and removing a long-sleeved jacket. The participants will be required to put on a long-sleeved coat completely, so that it was straight on their shoulders, and then to remove it completely, while maintaining a standing position. The time taken to complete the task was recorded.
Time frame: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).
Motor Activity Log (MAL)
The motor activity log (MAL) will be used to assess the ADLs. The MAL has 30 items including object manipulation and upper limb gross activities. Each item is in both quality of movement and amount of movement on a 6-point Likert scale (0-5). The total scale ranges from 0 to 150 with higher score indicate better ADL.
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TENS will be delivered with commercial TENS machine. The stimulation parameters were as follows: continuous 0.2-ms square pulses at 100 Hz with the intensity adjusted according to the tolerance of each patient. Disposable surface electrodes of 5X5 cm2 were applied to stimulate the median nerve and the superficial radial nerve of both the affected and non-affected upper limbs. The placebo stimulation was delivered with a device that looked identical but had its internal electrical circuit disconnected.
The sham stimulation will be administered using a device that looks identical to the TENS device used in the TENS intervention. However, the internal electrical circuit of this device will be disconnected.
A physiotherapist supervised the intervention and monitored individual progress. The task-oriented training aims to improve the motor recovery of the upper limbs through the systematic and repetitive movement of shoulder, elbow, forearm, wrist and fingers. The task-oriented training will be conducted in seating position with a table in front. Each training task will be repeated for 10 repetitions per set with 1 minute of rest between sets.The progressions are repositioning from gravity eliminate to against position, improve movement quality, increasing number of sets and shortening rest period.
Time frame: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).
Capabilities of upper extremity test (CUE-T)
The CUE-T will be used to assess the upper limb function capacity. It consists of 19 unilateral and bilateral upper limb tasks. Depending on the item, scoring is based on performance of the task, the number of repetitions of the task, or time to complete the task. Raw scores are converted to a 5-point scale (0-4). Total score ranges from 0 to 120 with higher score indicate greater functional capacity. Affected side or unaffected side scores can be obtained by adding the score of the unilateral items on each side
Time frame: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).
Hand grip strength
The K-Grip hand-hold dynamometer (K-Grip, kinvent biomecanique, Montpellier, France) will be used for hand grip measurement. The participants will be seated in a comfortable chair with arm support and elbow in 90° flexion. Participants will be asked to make a maximal effort for at least 5 s with verbal encouragement. There were three trials for both side and the average value will be used for statistical analysis.
Time frame: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).
Pinch grip strength
The electronic Jamar pinch gauge will be used to measure the later pinch grip strength. The participants will be seated in a comfortable chair with arm support and elbow in 90° flexion. Participants will be asked to make a maximal effort for at least 5 s with verbal encouragement. There will be three trials for both side and the average value will be used for statistical analysis.
Time frame: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).
Capabilities of upper extremity-questionnaire (CUE-Q)
The CUE-Q will be used to assess the self-prospective functional limitation. It consists of 32 for unilateral and bilateral upper limb use, addressing areas of reaching and lifting, pulling, and pushing, wrist actions, and hand and finger actions. The responses are given on a 5-point Likert scale representing self-perceived difficulty in performing the action. Total score ranges from 0 to 160 with higher score indicate lesser functional limitation.
Time frame: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).
Stroke impact scale (SIS)
The SIS will be used to assess the quality of life. The SIS comprises 59 items covers eight domains of quality of life and an extra question on stroke recovery. Each item is rated on a 5-point Likert scale in terms of the difficulty in completing each item. The summative scores are generated for each domain, ranging from 0 to 100.
Time frame: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).
Community integration measure(CIM)
The Chinese version of CIM will be used to assess individuals' perceptions of community integration. It is a 10-item questionnaire with each item rated on a 5-point Likert scale, yielding a total score that ranges from 10 to 50. Higher scores indicate a better degree of perceived community integration.
Time frame: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).