N/A
N=53
Development of Walk Assist Device to Improve Community Ambulation
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01994395 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Change in 10 Meter Walk Test From Baseline in Gait Speed — 0.7051; 0.6606; 0.8544; 0.7547 meters per second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- The Stride Management Assist (SMA) System (Device); Impairment based therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shirley Ryan AbilityLab
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 10 Meter Walk Test From Baseline in Gait Speed |
0.7051; 0.6606; 0.8544; 0.7547; 0.9566; 0.8376 | — |
| SECONDARY Activities-Specific Balance Confidence Scale (ABC) |
66.7625; 67.6472; 73.2067; 70.4443; 79.1630; 77.99 | — |
| SECONDARY Numeric Pain Rating Scale (NPRS) |
0.733336; 0.680004; 1.166668; 0.72458; 0.879996; 0.599995 | — |
| SECONDARY Stroke Specific Quality of Life Scale (SS-QOL) |
198.16; 193.84; 204.8; 205.36; 205.6; 211.72 | — |
| SECONDARY The Modified Falls Efficacy Scale (mFES) |
8.3803; 8.4426; 8.9228; 8.719996; 9.0971; 9.075176 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
3.72; 3.68; 2.88; 3.12; 2.32; 2.16 | — |
| SECONDARY Participants Receiving Transcranial Magnetic Stimulation (TMS) |
15; 15; 15; 15 | — |
| SECONDARY Change in 6 Minute Walk Test From Baseline in Distance (6MWT) |
874.6067; 794.33; 1140.5040; 963.1633; 1268.24; 1065.5567 | — |
| SECONDARY Berg Balance Scale (BBS) |
44; 44; 46; 46; 48; 48 | — |
Summary
Hypothesis/Specific Aims:
The purpose of this study is to determine the effect of training with the Stride Management Assist (SMA) device vs. Impairment based physical therapy (IPT) on descending corticospinal drive to the lower limb muscles in patients post stroke. The investigators hypothesize that long-term SMA use would strengthen the connections between the motor areas of the brain and the lower limbs. Specifically, individuals in the SMA group will show higher corticospinal excitability of the lower limb muscles compared to those in the IPT group.
Eligibility Criteria
Inclusion Criteria
- ≥ 30-days post stroke
- Initial gait speed of > 0.4 m/s and 17)
- Subject is willing to be randomized to the control group or the treatment group.
- Ability to sit unsupported for 30 seconds
- Ability to walk at least 10m with maximum 1 person assist,
- Ability to follow a three-step command
- Physician approval for patient participation
- Living in the community post-stroke with ability to travel to the intervention site to participate in the outpatient program and able to perform the home exercise program in the residential facility.
- Willing to carry wireless body sensors through the period of the study and to follow-up time period, post inpatient stroke, cardiac, pulmonary, or any other lower extremity physical rehabilitation
- ≥ 90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement)
- ≥ 6 months post coronary artery bypass grafting (CABG) or cardiac valve procedure
- Able and willing to give written consent and comply with study procedures, including follow-up visits
- Cannot not be participating in any other structured outpatient or home health physical therapy program
Exclusion Criteria
- Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
- Severe arthritis or orthopedic problems that limit passive ranges of motion (ROM) of lower extremity (knee flexion contracture of > 10°, knee flexion ROM 25°, and ankle plantar flexion contracture > 15
- Serious medical conditions including myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living, Severe hypertension, severe weight bearing pain, life expectancy less than one year
- Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia
- History of major head trauma, Lower extremity amputation, Non-healing ulcers of a lower extremity, Renal dialysis or end stage liver disease, Legal blindness or severe visual impairment, a history of significant psychiatric illness
- History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits
- Medications that lower seizure threshold
- History of concussion in last 6 months
- Subject is pregnant, nursing or planning a pregnancy
- Inability to travel 3 times per week for outpatient training programs
- Participating in another clinical trial that, according to the Principal Investigator, is likely to affect study outcome or confound results
Data sourced from ClinicalTrials.gov (NCT01994395). 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.