| OUTCOMES |
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Type of outcome
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Outcome
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Timepoint(s) at which outcome measured
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| Primary Outcome |
The American Spinal Injury Association: International Standards for Neurological Classification of Spinal Cord Injury. This instrument is used to establish the neurological level of injury, as well as the severity of the lesion or impairment and rectal examination for voluntary anal contraction and anal sensation, in patients with SCI, using the following categories:
A = Complete: No sensory or motor function is preserved in sacral segments S4-S5
B = Incomplete: Sensory, but not motor function is preserved below the neurologic level and extends through sacral segments S4-S5.
C = Incomplete: Motor function is preserved below the neurologic level, and most key muscles below the neurologic level have a muscle grade of less than 3.
D = Incomplete: Motor function is preserved below the neurologic level, and most key muscles below the neurologic level have a muscle grade that is greater than or equal to 3.
E = Normal: Sensory and motor functions are normal.
Use of the ASIA scale will assure uniformity in the patient population |
At point of initial assessment, at 6 weeks, 12 weeks, 18 weeks and 24 weeks. |
| Primary Outcome |
The Walking Index for Spinal Cord Injury II. The purpose of this scale is for use in clinical trials to measure improvements in walking in persons with spinal cord injury. The following outline describes subjects for whom the scale is most commonly utilized.
1. Spinal cord injury subjects who are capable of standing and walking in the parallel bars will be eligible for assessment. Only a reciprocal gait is to be considered in scoring the WISCI scale. Additional inclusion/exclusion criteria may be necessary.
2. Most often ASIA A below T10 and ASIA B, C, and D subjects may qualify.
3. Individuals with tetraplegia would require motor strength in triceps of at least grade 3 or be able to support their body weight.
Standardized Physical Environment and Distance
This is a functional limitation scale, not a disability scale. It must be used in a standardized environment with standardized equipment and definitions, which are observed and recorded by professional staffs that are trained. The subject is observed by the trained personnel and the WISCI level is recorded on the scale of 0 to 20 at baseline (Baseline WISCI). The subject is observed again at the defined interval (Interval WISCI). The change in score is calculated by subtracting the baseline WISCI from the Interval WISCI, which equals the change in WISCI (Changed WISCI). If a group of subjects are enrolled, medians and means may be calculated. |
At the point of first assessment, at 6 weeks, 12 weeks, 18 weeks and 24 weeks. |
| Primary Outcome |
Spinal Cord Independence Measure (SCIM)
The SCIM was developed to address three specific areas of function in patients with spinal cord injuries (SCI). It looks at self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and a patient’s mobility abilities (bed and transfers and indoors/outdoors). Additionally, the SCIM is also used to help guide clinicians in determining treatment goals and objectives for patients with an SCI.
It is used by clinicians through direct observation of the activities listed or through patient report or interview information. The SCIM takes approximately 30-45 minutes to administer and score and is user friendly. Its scoring system is self-explanatory. Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence. Each subscale score is evaluated within the 100-point scale (self-care: 0-20; respiration and sphincter management: 0-40; mobility: 0-40).
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At point of first assessment, at 6 weeks, at 12 weeks, at 18 weeks and at 24 weeks. |
| Primary Outcome |
The Neuromuscular Recovery Scale (NRS) is a new and unique measure of the degree a person who has sustained a spinal cord injury (SCI) has recovered the ability to perform functional tasks relative to how the individual performed these tasks prior to injury (i.e. the same movement pattern and without compensation such as assistive device or substitution by another muscle).
NRS is more effective than other measures (of balance, walking, or sensorimotor impairments) to classify SCI patients into functionally similar groups.
The NRS may thus be a more sensitive instrument for assessing the therapeutic effect of an intervention tested in clinical trials and studies with the aim of achieving recovery after SCI.
The NRS can provide the therapist and patient an effective means to quantify recovery, set goals, and assess progress.
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At point of first assessment, at 12 weeks and at 24 weeks. |
| Secondary Outcome |
Thigh Girth and Calf Girth is measured with the use of a measuring tape. The thigh girth is taken at 25 centimeters from the anterior superior iliac crest while the calf girth is taken at a point 25 centimeters from the lateral malleolus. This is to assess any changes in muscle bulk during the period of the study. |
At the point of first assessment, at 6 weeks, at 12 weeks, at 18 weeks and at 24 weeks. |