Development of Walk Assist Device to Improve Community Ambulation

NCT01994395 | Completed Results DMC

• 1 other identifier: NUSTU00085161
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Gait; Stride Management Assist; Mild-moderate Stroke, post 30 days or longer

Outcome Measures

Primary Outcomes (1)

• Change in 10 Meter Walk Test From Baseline in Gait Speed

  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."

  Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

Secondary Outcomes (8)

• Activities-Specific Balance Confidence Scale (ABC)

  Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

• Numeric Pain Rating Scale (NPRS)

  Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

• Stroke Specific Quality of Life Scale (SS-QOL)

  Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

• The Modified Falls Efficacy Scale (mFES)

  Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)

Study Arms (2)

Stride Management Assist (SMA) System

EXPERIMENTAL

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

Impairment based therapy

ACTIVE COMPARATOR

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

Interventions

The Stride Management Assist (SMA) System DEVICE

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.

Stride Management Assist (SMA) System

Impairment based therapy OTHER

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

Impairment based therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Honda: collaborator

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60657, United States

Location

Related Publications (2)

• Jayaraman A, O'Brien MK, Madhavan S, Mummidisetty CK, Roth HR, Hohl K, Tapp A, Brennan K, Kocherginsky M, Williams KJ, Takahashi H, Rymer WZ. Stride management assist exoskeleton vs functional gait training in stroke: A randomized trial. Neurology. 2019 Jan 15;92(3):e263-e273. doi: 10.1212/WNL.0000000000006782. Epub 2018 Dec 19.

  PMID: 30568009 DERIVED

• Buesing C, Fisch G, O'Donnell M, Shahidi I, Thomas L, Mummidisetty CK, Williams KJ, Takahashi H, Rymer WZ, Jayaraman A. Effects of a wearable exoskeleton stride management assist system (SMA(R)) on spatiotemporal gait characteristics in individuals after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2015 Aug 20;12:69. doi: 10.1186/s12984-015-0062-0.

  PMID: 26289955 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Limitations and Caveats

Intervention was limited to 6-8 weeks with a follow-up of 3 months. Determining if effects lasted more than 3 months and length of therapy needed to achieve long lasting effects is beneficial. A custom fitting SMA may enhance outcomes in users.

Results Point of Contact

• Title: Arun Jayaraman, PT, PhD; Director of Max Nader Lab for Rehabilitation Technologies and Outcomes
• Organization: Rehabilitation Institute of Chicago

ajayaraman@ricres.org

3122386875

Study Officials

• Arun Jayaraman, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 27, 2020
• Results First Posted: October 31, 2017

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)