Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in muscle synergies during walking |
Muscle synergies are groups of muscles that receive a common input from the brain. The researchers will assess the number of muscle synergies and the similarity of muscle synergies to those of healthy individuals. The researchers will calculate from the electromyographic (EMG) activity and compare the number and similarity of muscle synergies to healthy individuals via a similarity index. These measures will be assessed between legs, over time, and between groups. An increase in number of synergies and an improvement in similarity of synergies is a better outcome. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in 10 Meter Walk Test |
The 10 Meter Walk Test is a common clinical measure of gait speed. Participants will be directed to walk at their comfortable, self-selected speed. Participants will be positioned at the start line and instructed to walk the entire 10 meter distance while the therapist times the middle six meters. The distance before and after the timed course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.46 sec). The test will be performed two times at self-selected speed with adequate rest in between. The average of the two times should be recorded. The test will then be repeated with the participants directed to walk at their fast but safe speed. Appropriate assistive devices, bracing, and the minimal amount of physical assistance from the physical therapist will be applied. A faster speed/shorter time is a better outcome. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in 6 Minute Walk Test |
The 6 Minute Walk Test measures the distance a participant can walk indoors on a flat, hard surface in a period of six minutes. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test is self-paced. Participants are allowed to stop and rest during the test; however, the timer does not stop. If a participant is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. Appropriate assistive devices, bracing, and the minimal amount of physical assistance from the physical therapist will be applied. A longer distance is a better outcome. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in Berg Balance Scale |
The Berg Balance Scale is a 14-item test, scored on a five point ordinal scale. It measures functional balance in a clinical setting and includes static and dynamic tasks (such as sitting, standing, transitioning from sitting to standing, standing on one foot, retrieving an object from the floor), during which participants must maintain their balance. A higher score is a better outcome. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in Functional Gait Assessment (FGA) |
The FGA is a 10-item test, scored on a four point ordinal scale. A higher score indicates decreased fall risk and is a better outcome. It measures dynamic balance and postural stability during walking tasks (such as fast walking, backward walking, stepping over an obstacle) in the clinical setting. Patients are allowed to use an assistive device for certain items. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in Manual Muscle Test |
Manual Muscle Test is a procedure for evaluating the strength of 16 individual muscles relative to gravity and manual resistance. Instructions are provided to the participant before testing each muscle. 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" to "strong" 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). Higher strength is a better outcome. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in Modified Ashworth Scale |
The Modified Ashworth Scale is a 6-point ordinal scale used to grade the amount of hypertonicity in individuals with neurological diagnoses. 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. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in time spent in age-predicted maximum heart rate zone |
The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant utilizing Hrmax = 208 - [0.7 × age] as developed by Tanka et al in 2001. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. More time spent in their pre-calculated target zone is a better outcome. |
Each session through completion of study, up to 6 weeks |
|
| Secondary |
Change in Borg Rating of Perceived Exertion |
The Borg Rating of Perceived Exertion is a tool to measure the subjective report of effort, exertion, and fatigue during physical work. It consists of a 15-point scale from 6-20, in which 6=no exertion and 20=absolute maximum exertion. It is presented to the participant in written format with descriptors to standardize the report of perceived exertion across tasks. |
Each session through completion of study, up to 6 weeks |
|
| Secondary |
Change in Step Count |
The number of steps taken during the week prior to and following completion of the training program will be measured using activity monitors/pedometer to assess patient participation (i.e., activity outside of the study). These devices are small accelerometers that can be worn on a belt and/or on the ankle to record steps and Kcals during an activity. A higher step count is a better outcome. |
One week prior to initiating training sessions, and one week following the conclusion of all training sessions |
|
| Secondary |
Change in Global Rating of Change |
The Global Rating of Change scale is a subjective outcome measure used to independently score self-perceived improvement. It quantifies a participant's improvement or deterioration over time to determine the effect of an intervention. It consists of an 11-point scale from -5 to +5 in which -5=much worse, 0=unchanged, and +5=completely recovered. It is presented to the participant in written format as a visual analog scale. A higher score is a better outcome. |
Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions for post-stroke participants; every 5-8 sessions delivered per intervention for therapist participants |
|
| Secondary |
Change in System Usability Scale |
The System Usability Scale (SUS) is a simple, ten-item scale giving a global view of subjective assessments of usability. The items cover a variety of aspects of system usability, such as the need for support, training, and complexity. A 5-point Likert scale ranging from 1 to 5 is used for each item, in which 1=strongly disagree, 3= neutral, and 5=strongly agree. The SUS is presented to the therapist participant in written format. It yields a single number representing a composite measure of the overall usability of the system being studied. Scores for individual items are not meaningful on their own. SUS scores have a range of 0 to 100. |
Every 5-8 sessions (e.g., 2-3 weeks) delivered by the therapist per intervention |
|
| Secondary |
Change in "The Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure" |
The Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure collectively have 12 items (four for each construct) that are both valid and reliable measures of these implementation outcomes. These measures could be used independently or together. A 5-point Likert scale ranging from 1 to 5 is used for each item, in which 1=completely disagree, 2= disagree, 3= neither agree nor disagree, 4=agree, and 5=completely agree. These measures are presented collectively to the therapist participant in written format. |
Every 5-8 sessions (e.g., 2-3 weeks) delivered by the therapist per intervention |
|
| Secondary |
Change in stride time variability |
Stride variability is the ratio between the standard deviation and mean of stride time, expressed as a percentage. Decreased variability indicates a better outcome. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| 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. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in stride length |
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. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| 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. Right and left stance times are normally equal. It includes single support and double support. Equal stance time between limbs is a better outcome. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in joint angle |
Joint angle is measured at key gait events (e.g., heel strike, toe off, etc.) as the average angle that the hip, knee, and ankle are at during the gait event. Right and left joint angles are normally equal. Typically a more equal joint angle between limbs is a better outcome. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in joint velocity |
Joint velocity is measured at key gait events (e.g., heel strike, toe off, etc.) as the average velocity that the hip, knee, and ankle are at during the gait event. Right and left joint velocity are normally equal. Typically a more equal joint velocity between limbs is a better outcome. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in variation in center of gravity |
Center of gravity will be measured during the walking tasks and balance tasks as a measure of how balanced the subject is dispersing their weight between their two limbs. Typically a lower variation in center of gravity is a better outcome. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in EMG Magnitude and Gait Phase Components of Muscle Activity |
Average EMG activation magnitude at key gait events (e.g., heel strike, toe off, etc.) and during key phases of the gait cycle (e.g., stance phase, swing phase, etc.) will be computed for each leg. An average magnitude (in volts) of muscle activity for each muscle will be computed for each gait event/phase of gait cycle and a ratio of affected over unaffected will be computed for each muscle and event/phase. Typically, a more balanced magnitude of muscle activation between the two legs and more consistent gait phase is a better outcome. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in Neural synergies |
The neural synergies are group of muscles that receive a common input from the brain. The researchers will calculate this from the EMG and associate the common input as the level of correlated activity between muscles. The researchers will compare this level of correlated activity between the legs and arms for both walking and balance tasks. |
Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in Patient Questionnaire |
The patient questionnaire will ask the patient to assess how their walking ability has changed from before starting the rehabilitation program. Additionally, patients will have an opportunity to provide any written feedback on the therapy. |
Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions |
|
| Secondary |
Change in Therapist Questionnaire |
Therapists will complete questionnaires that reflect the perceived usefulness of the rehabilitation device/program, the usability of the device, and the feasibility of implementing the intervention . Therapists will also have an opportunity to provide any written feedback on the therapy. |
Every 5-8 sessions (e.g., 2-3 weeks) of administering a particular intervention |
|
| Secondary |
Change in Preparation and Breakdown Time |
During the training session, preparation and breakdown time will be recorded as the time it takes for the therapist to set up and remove the equipment for the therapy session. This will be compared between groups and over time. A reduction in time is a better outcome. |
Every training session over 6 weeks with 3 training sessions per week |
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