Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change from baseline: ASIA impairment scale |
The American spinal injury association is a universal classification tool for spinal cord injuries based on a standardized sensory and motor assessment, to determine the Sensory Level and Motor Level for each side of the body (Right and Left), the single Neurological Level of Injury (NLI) and whether the injury is Complete or Incomplete. For the Key Sensory point that related to the dermatomes C2 - S5. They are tested bilaterally using Light Touch (LT) (tested by cotton tip) and Pin-Prick (PP) [sharp-dull discrimination]. For motor examination, key motor function of the myotomes C5 - T1 and L2 - S1 are tested bilaterally. |
Baseline, post-intervention day 30, and 1-month after post-intervention |
|
Secondary |
Change from baseline: the soleus H-reflex |
The soleus H-reflex is a monosynaptic response that is reliably elicited in the lower limb by stimulating the posterior tibial nerve (PTN) in the popliteal fossa. The H-reflex is evoked in the soleus muscle by percutaneous PTN stimulation with a 1 ms duration stimulus delivered at 0.33 Hz. Surface electrodes are used to record the H-reflex and motor (M) response from the soleus muscle. The M response represents direct motor activation, while the H-reflex appears later. The latency of the M response is 5-10 msec, while the H-reflex latency is 25-35 msec. Expressing the H-reflex as a percentage of the maximum M response (Mmax) allows for comparisons between individuals. The H-reflex response (Hmax) and Mmax will be recorded to calculate the H-reflex latency and H/M amplitude ratio. |
Baseline, post-intervention day 30, and 1-month after post-intervention |
|
Secondary |
Change from baseline: Modified Ashworth scale |
A clinical tool used to measure the increase of muscle tone. |
Baseline, post-intervention day 30, and 1-month after post-intervention |
|
Secondary |
Change from baseline: Deep tendon reflex score |
A clinical tool used to measure muscle stretch reflex response |
Baseline, post-intervention day 30, and 1-month after post-intervention |
|
Secondary |
Change from baseline: Upper limb muscle strength |
This test will be used for assessing the improvement of upper limb muscle strength including shoulder flexor, shoulder abductor, shoulder extensor shoulder adductor, elbow flexor, wrist extensor, elbow extensor, and wrist flexor on both sides. The muscle strength will be assessed by using hand-held dynamometer (Lafayette Electronic Hand-held Dynamometer). This test had good reliability for testing in SCI. The participants will be asked to exert force against the dynamometer over a period second while the assessor will hold the dynamometer steady against their effort. The peak force (Newton) will be chosen for an outcome. |
Baseline, post-intervention day 30, 1-month after post-intervention |
|
Secondary |
Change from baseline: Spinal cord independence measure III (SCIM III) |
The Spinal Cord Independence Measure (SCIM) is a scale for the assessment of achievements of daily function of patients with spinal cord lesions (SCLs). The third version (SCIM III) contains 19 tasks organized in 3 subscales: self-care, respiration and sphincter management, and mobility. This study will assess only 2 subscales of self-care and mobility. |
Baseline, post-intervention day 30, 1-month after post-intervention |
|
Secondary |
Change from baseline: Transfer assessment instrument (TAI) |
The TAI evaluates wheelchair preparation, body setup, and flight phases of the transfer. It has good face, content, and construct validity for community-dwelling mobility device users. Each of the items in the TAI is scored "yes" (1 point), "no" (0 points), or "not applicable" (item not included in scoring), resulting in a minimum score of 0 and a maximum score of 10. |
Baseline, post-intervention day 30, 1-month after post-intervention |
|
Secondary |
Change from baseline: Quality of life measure |
The participants' QOL will also be evaluated by using the WHOQOL-BREF-Thai questionnaire that can be assessed by self-report. In situations that the participants cannot read, the assessor will read for them, and they will have to choose the answer by themselves. The WHOQOL-BREF questionnaire has two types of questions: perceived objective and self-report subjective, and it includes four components of well-being: physical, psychological, social, and environmental. Each item is scored from 1-5. This Thai version has a good internal consistency with Cronbach's alpha 0.84. The higher score indicates better QOL. |
Baseline, post-intervention day 30, 1-month after intervention |
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