N/A
N=12
Walk Assist Device to Improve Community Ambulation
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03222505 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Change in Six Minute Walk Test Between Device Turned ON and OFF - Distance Traveled — 837.1; 804.8 feet
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Honda Stride Assist Device ON (Device); No Device Worn (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shirley Ryan AbilityLab
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Six Minute Walk Test Between Device Turned ON and OFF - Distance Traveled |
837.1; 804.8 | — |
| PRIMARY Change in Peak Treadmill (TM) Velocity Between Device Turned ON and OFF - Self Selected Walking Speed |
0.95; 0.84 | — |
| SECONDARY Percent Change in Excitability of Transcranial Magnetic Stimulation (TMS) Rectus Femoris (RF) Between Device ON and Device OFF |
19.02 | — |
| SECONDARY Change in Percent Excitability of Transcranial Magnetic Stimulation (TMS), Dorsiflexor Tibialis Anterior (TA) Between Device ON and Device OFF |
-13.53 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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, 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.
-
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03222505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.