Development of Walk Assist Device to Improve Community Ambulation

Measure of self selected and fast walking speeds by measuring the time it takes an individual to walk 10 meters. The test is performed using a flying start, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: Please walk this distance at your normal pace when I say go. and repeated Please walk this distance as fast as you can safely when I say go.

Time frame: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

Population: One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.

ABC is a 16-item self-report measure in which patients rate their balance confidence in performing various ambulatory activities without falling. Items are rated on a scale ranging from 0-100, with zero representing no confidence and 100 representing complete confidence.

Time frame: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

Population: One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.

The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance. The minimal detectable change score for individuals with acute stroke is 6.9 points16 and 4.66 points in chronic stroke17.

Time frame: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

Population: One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.

The 6 Minute Walk Test (6MWT) is a test of endurance, by measuring the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.The distance is measured with a measuring wheel. The instructions are Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed, but time will keep running. The change in the distance walked in the 6-minute walk can be used to evaluate the efficacy of an exercise-training program or to trace the natural history of change in exercise capacity over time. The 6MWT is measured in meters.

Time frame: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

Population: One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.

The NPRS is an 11-point scale from 0-10 where patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours from 0 (no pain) to 10 (the most intense pain imaginable).

Time frame: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

Population: One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.

To compare the effect of training on the connections between the brain and leg muscles (descending corticomotor drive) using a non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals13. Very short duration (\< 1 ms) magnetic pulses are applied via an insulated wire coil placed on the intact scalp overlaying the motor cortical area projecting to a target muscle. Each pulse induces a motor evoked potential (MEP) in a target muscle that can be readily monitored by recording Electromyogram (EMG) from that muscle. A figure-of-eight or double cone coil is typically used to deliver focal magnetic pulses to a number of scalp sites over the cortical area representing a muscle of interest.

Time frame: Session 0 (initial visit);Session 20 (between 6-8 weeks)

Population: One subject dropped before being assigned to a group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.

PHQ-9 is a 9-item self-report questionnaire designed to diagnose both the presence of depressive symptoms as well as to characterize the severity of depression. A single question rates how difficult problems have made it to do work, take care of things at home or get along with other people using a 4 level scale (not difficult at all to extremely difficult). Each item is scored from 0-3; total scores may be 0-27, with higher scores representing increased severity of depression.

Time frame: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

Population: One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.

A 49 item assessment grouped into 12 domains of health-related quality of life in stroke survivors; including areas of mobility, energy, upper extremity function, work and productivity, mood, self-care, social roles, family roles, vision, language, thinking, personality. Each individual domain consists of 3 to 10 items that are averaged to generate an overall score, each item is rated on a 5- point Likert scale, with a minimum value of 1 (meaning the worst outcome) and a maximum value of 5 (meaning the best outcome). Domains scores (non-weighted average of item scores) and a summary score (non-weighted average of all 12 domain scores) are computed. Summary scores range from 49-245, with higher scores indicating better functioning.

Time frame: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

Population: One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.

14 item questionnaire assessing individuals' confidence in their ability to perform tasks without falling. Individuals rate their confidence from 0 (not confident at all) to 100 (completely confident).

Time frame: Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

Population: One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.