Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in 10-meter walking test (10MWT) |
The 10-meter walking test (10MWT) is a physical function test measuring the total time to ambulate 10 meters in order to calculate walking speed in meters per second. A shorter time indicates a better walking speed. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Primary |
Change in 6-minute walking test (6MWT) |
The 6-minute walking test (6MWT) is a physical function test measuring the total distance walked in a span of six minutes will be assessed. A longer distance indicates a better walking distance. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Change in motor and sensory scores (ASIA) |
The American Spinal Injury Association Impairment Scale (AISA) is a standardized neurological examination used to assess the sensory and motor levels which were affected by the spinal cord injury. A clinician will assess sensory and strength in both upper and lower extremities to provide both a neurologic level of injury and classification level. The five classification levels, ranging from complete loss of neural function in the affected area (Grade A) to completely normal (Grade E). A score closer to Grade E is a better outcome. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Change in balance with the Berg balance scale (BBS) |
Change in static and dynamic sitting and standing balance will be assessed using the Berg balance scale (BBS). Items are scored from zero to four. A higher score indicates better balance and decreased fall risk. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Change in walking ability with the WISCI |
The Walking Index for Spinal Cord Injury (WISCI) assesses the ability of a person to walk after spinal cord injury. It consists of a rank ordering at the impairment level from most severe (0) to least severe (20) based on the amount of physical assistance required and use of assistive devices and/or braces while walking a 10-meter distance. A higher score indicates better walking ability. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Change in Modified Ashworth Scale (MAS) |
The Modified Ashworth Scale (MAS) is a physical function test measuring spasticity on a 6-point ordinal scale. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. A lower score is a better outcome. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Change in muscle testing or strength |
Physical function test measuring strength of the muscle of interest. A muscle is isolated, and gradual external force is applied at a right angle to the muscle's long axis. Each muscle is scored on a graded scale of "weak" (score of 0) to "strong" (score of 5) based on the participant's ability to resist the external force. The test is first completed for muscles on the unimpaired side to determine normal strength before being repeated on the impaired side. Weaker participants may be tested while lying prone (gravity eliminated). A higher score value indicates higher strength and improvement. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Changes in EMG activation patterns |
Electrodes will record muscle activity from the main leg muscles (e.g., soleus (SOL), tibialis anterior (TA), quadriceps (QS), hamstrings (HS)) during walking. Features closer to that of a healthy individual is a better outcome. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Changes in interlimb (upper-lower limb) modulation |
This will be assessed by measuring changes in the magnitude and pattern of H-reflex suppression in the soleus (ankle extensor) of the leg during arm cycling. Features closer to that of a healthy individual is a better outcome. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Changes in the strength of cortico-spinal connectivity |
This will be measured using transcranial magnetic stimulation (TMS) of the motor cortex known to produce a motor evoked potential (MEP) in the main muscles of the leg, and peak-to-peak amplitude of the MEP and recruitment curves of MEP amplitude as a function of TMS strength will be calculated and constructed. Recruitment curves closer to that of a healthy individual is a better outcome. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Changes in strength of periphery and somatosensory cortex |
This will be measured using cutaneous electrodes on the arm and leg skin surface and recording the somatosensory evoked potentials (SEPs) over the primary somatosensory cortex using electroencephalography (EEG) electrodes; peak-to-peak amplitude of the SEP and recruitment curves of SEP amplitude as a function of stimulus strength will be calculated and constructed. Recruitment curves closer to that of a healthy individual is a better outcome. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Change in stride variability. |
Stride variability is the ratio between the standard-deviation and mean of stride time, expressed as percentage. Decreased variability indicates a better outcome. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Change in cadence. |
Cadence is the total number of steps taken within a given time period; often expressed per minute. Typically a higher number of steps is a better outcome. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Change in step length. |
Step length is the distance between the point of initial contact of one foot and the point of initial contact of the opposite foot. Typically a longer step length is a better outcome, ideally with equal measurements between left and right limbs. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Change in stride length. |
Stride length is the distance between successive points of initial contact of the same foot. Right and left stride lengths are normally equal. Typically a longer stride length is a better outcome, ideally with equal measurements between left and right limbs. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
| Secondary |
Change in stance time. |
Stance time is the amount of time that passes during the stance phase of one extremity in a gait cycle. It includes single support and double support. Equal stance time between limbs is a better outcome. |
Changes across baseline, after 3 weeks of training, after 6 weeks of training, after 9 weeks of training, after 12 weeks of training, and 6 months after completing training. |
|
