Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Development of Walk Assist Device to Improve Community Ambulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01994395
Recruitment Status : Active, not recruiting
First Posted : November 25, 2013
Results First Posted : October 31, 2017
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Honda
Information provided by (Responsible Party):
Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Brief 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.


Condition or disease Intervention/treatment Phase
Stroke Device: The Stride Management Assist (SMA) System Other: Impairment based therapy Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The SMA group (task specific training) will be trained to simulate the demands of overground walking. The impairment based group will match the SMA group in intensity but will be focused on balance and other functional goals rather than explicitly on walking. The rationale of this study is to assess task specific training with SMA vs. impairment based training. To this end, we will use the Stride Management Assist device by Honda Corporation and compare it to impairment based physical therapy in outpatient sessions.
Masking: Single (Outcomes Assessor)
Masking Description: A blinded research physical therapist will test the outcome measure at baseline, Mid Testing after Session 9 , at Post Testing after Session 18 and at 3 month follow up testing after Session 18.
Primary Purpose: Treatment
Official Title: Randomized Control Trial Comparing Walking Task Specific Training With Stride Management Assist (SMA) Device vs.Functional Task Specific Training on Functional Walking Ability in Outpatient Stroke Rehabilitation
Study Start Date : October 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: Stride Management Assist (SMA) System
Participants will be randomized into either the SMA group or impairment based (IPT) group. The SMA group (task specific training) will be trained to simulate the demands of overground walking using the Stride Management Assist Device in outpatient physical therapy.
Device: The Stride Management Assist (SMA) System
Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.

Active Comparator: Impairment based therapy
Impairment based therapy will include traditional functional mobility training physical therapy. It will match the SMA group in intensity but will be focused on balance and other functional goals rather than explicitly on walking in outpatient physical therapy.
Other: Impairment based therapy
Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training




Primary Outcome Measures :
  1. Change in 10 Meter Walk Test From Baseline in Gait Speed [ 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) ]
    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."


Secondary Outcome Measures :
  1. Activities-Specific Balance Confidence Scale (ABC) [ 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) ]
    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.

  2. Numeric Pain Rating Scale (NPRS) [ 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) ]
    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).

  3. Stroke Specific Quality of Life Scale (SS-QOL) [ 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) ]
    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.

  4. The Modified Falls Efficacy Scale (mFES) [ 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) ]
    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).

  5. Patient Health Questionnaire-9 (PHQ-9) [ 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) ]
    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.

  6. Participants Receiving Transcranial Magnetic Stimulation (TMS) [ Time Frame: Session 0 (initial visit);Session 20 (between 6-8 weeks) ]
    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.

  7. Change in 6 Minute Walk Test From Baseline in Distance (6MWT) [ 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) ]
    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.

  8. Berg Balance Scale (BBS) [ 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) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 30-days post stroke
  • Initial gait speed of > 0.4 m/s and < 0.8 m/s
  • Adequate cognitive function (MMSE score >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 < 90°, hip flexion contracture > 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994395


Locations
Layout table for location information
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60657
Sponsors and Collaborators
Shirley Ryan AbilityLab
Honda
Investigators
Layout table for investigator information
Principal Investigator: Arun Jayaraman, PhD Shirley Ryan AbilityLab
  Study Documents (Full-Text)

Documents provided by Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Arun Jayaraman, PT, PhD, Research Scientist, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT01994395     History of Changes
Other Study ID Numbers: NUSTU00085161
First Posted: November 25, 2013    Key Record Dates
Results First Posted: October 31, 2017
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab:
Stroke
Gait
Stride Management Assist
Mild-moderate Stroke, post 30 days or longer

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases