Clinical trial NCT03222505: Walk Assist Device to Improve Community Ambulation
Official title: Development of Walk Assist Device to Improve Community Ambulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Gait Stride Management Assist
Stroke, post 1 year or longer
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this research study was to examine the immediate effects of a prototype wearable robotic stride management assist device (SMA) designed by Honda R\&D® on clinical walking performance, walking energetics, gait kinematics and corticospinal excitability in individuals with stroke.

Detailed description: The goal of this research study was to examine the immediate effectiveness of a prototype wearable robotic stride management assist device (SMA) designed by Honda R\&D on clinical walking performance, walking energetics, gait kinematics and corticospinal excitability in individuals with stroke.

The SMA assists walking by providing a flexion and extension torque assist at the hip joint. The subjects in this study are asked to perform two sets of experiments: one set with the device on and one set with the device turned off. The order in which the subjects performed these sets of experiments is selected randomly. Each set of experiments includes over-ground walking speed and endurance tests, a graded treadmill test with metabolic measures, motion capture and force treadmill analysis, and measures of corticospinal drive using transcranial magnetic stimulation (TMS). The primary outcome to be measured is change in self-selected walking speed with the device on, the secondary outcome measures include metabolic, corticospinal and biomechanical analysis.

Eligibility criteria: Inclusion Criteria:

1. Stroke subjects with a history of unilateral, supratentorial, ischemic or hemorrhage stroke will be recruited, with lesion location confirmed by radiographic findings.
2. All subjects who score \> 10 on the Lower Extremity Motor Score (LEMS) developed previously to measure strength in Spinal Cord Injury (SCI). For the LEMS criteria, preliminary data indicate that subjects with LEMS \< 10 in the chronic stages do not recover walking.
3. All subjects will be required to walk \> 10 m over ground without physical assistance at self-selected walking speeds ≤ 0.8 m/s using assistive devices and bracing below the knee as needed. A criterion of 0.8 m/s is utilized to target participants with limited or minimal ambulation in the community. Subjects will be further stratified into those who walk \< 0.4 m/s and \> 0.4 m/s, identified as household vs. limited community ambulators, respectively.
4. Range of motion (ankle: -10 to 30 deg, knee: 0 to 90 deg, hip: -10 to 40 deg) consistent with gait;
5. Medically stable with medical clearance to participate (absence of concurrent illness, including unhealed decubiti, infection, cardiopulmonary disease, osteoporosis, active heterotrophic ossification or peripheral nerve damage in the lower limbs, history of traumatic head injury);
6. Able to tolerate 30 minutes of upright (standing) position without orthostasis (decrease in blood pressure by 20 mmHg systolic and 10 mmHg diastolic; minimized with ambulatory population);
7. Must not be undergoing concurrent physical therapy to eliminate effects of additional interventions;
8. Patients prescribed medications for spasticity will not be excluded from participation but will be asked to maintain current levels of medication or inform the researcher if changes are necessary.

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Exclusion Criteria:

1. Women of childbearing potential will not be excluded, although women who are pregnant will be excluded due to potential forces at trunk from body weight support or pelvic assistance;
2. Significant cardiorespiratory or metabolic disease that may limit exercise participation.
3. Weights limit \> 250 lbs (limit of most counter-weight safety systems).
4. History of previous orthopedic or neurological conditions which may impair walking.
5. Exclusion for TMS: pacemaker, metal implants in the head region, history of epilepsy or seizures, skull fractures or skull deficits, concussion within the last 6 months, unexplained recurring headaches, medications that lower seizure threshold, and pregnancy.
6. Subjects with scores \< 23 on the Mini Mental Status Exam will be excluded.

Primary outcomes:
measure: Change in Six Minute Walk Test Between Device Turned ON and OFF - Distance Traveled
timeFrame: Day 1
measure: Change in Peak Treadmill (TM) Velocity Between Device Turned ON and OFF - Self Selected Walking Speed
timeFrame: Day 1
Secondary outcomes:
measure: Percent Change in Excitability of Transcranial Magnetic Stimulation (TMS) Rectus Femoris (RF) Between Device ON and Device OFF
timeFrame: Day 1
measure: Change in Percent Excitability of Transcranial Magnetic Stimulation (TMS), Dorsiflexor Tibialis Anterior (TA) Between Device ON and Device OFF
timeFrame: Day 1
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: