Walk Assist Device to Improve Community Ambulation

Completed · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT03222505

Run by

Shirley Ryan AbilityLab

People needed

12

Starts

2010-01-01

Expected to finish

2018-05-01

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stroke subjects with a history of unilateral, supratentorial, ischemic or hemorrhage stroke will be recruited, with lesion location confirmed by radiographic findings.
• 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.
• 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.
• Range of motion (ankle: -10 to 30 deg, knee: 0 to 90 deg, hip: -10 to 40 deg) consistent with gait;
• 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);
• 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);
• Must not be undergoing concurrent physical therapy to eliminate effects of additional interventions;
• 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.

You may not qualify if…

• 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;
• Significant cardiorespiratory or metabolic disease that may limit exercise participation.
• Weights limit > 250 lbs (limit of most counter-weight safety systems).
• History of previous orthopedic or neurological conditions which may impair walking.
• 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.
• Subjects with scores < 23 on the Mini Mental Status Exam will be excluded.

Where it is running

• Rehabilitation Institute of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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