Walk Assist Device to Improve Community Ambulation

NCT03222505 | Completed Results DMC

• 1 other identifier: NUSTU00022438
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Gait Stride Management Assist; Stroke, post 1 year or longer

Outcome Measures

Primary Outcomes (2)

• Change in Six Minute Walk Test Between Device Turned ON and OFF - Distance Traveled

  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."

  Day 1

• Change in Peak Treadmill (TM) Velocity Between Device Turned ON and OFF - Self Selected Walking Speed

  Peak treadmill (TM) velocity: subjects walked on motorized treadmill with harness but no Body Weight Support (BWS). Testing started at 0.5 km/h and was increased in 0.5 km/h increments every 3 minutes until peak TM speed was achieved (identified as ability to sustain speed for ≥1min without stopping the treadmill).

  Day 1

Secondary Outcomes (2)

• Percent Change in Excitability of Transcranial Magnetic Stimulation (TMS) Rectus Femoris (RF) Between Device ON and Device OFF

  Day 1

• Change in Percent Excitability of Transcranial Magnetic Stimulation (TMS), Dorsiflexor Tibialis Anterior (TA) Between Device ON and Device OFF

  Day 1

Study Arms (2)

Treadmill

EXPERIMENTAL

Device: Honda Stride Assist Device ON; Other: No Device Worn

Overground Walking

EXPERIMENTAL

Device: Honda Stride Assist Device ON; Other: No Device Worn

Interventions

Honda Stride Assist Device ON DEVICE

Subjects performed assessments of walking and motor performance while wearing the Honda Stride Assist Device.

Overground Walking; Treadmill

No Device Worn OTHER

Subjects performed assessments of walking and motor performance without wearing the Honda Assist Device.

Overground Walking; Treadmill

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• Subjects with scores \< 23 on the Mini Mental Status Exam will be excluded.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

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, PT, 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: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 19, 2017
• Study Start: January 1, 2010
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Locations

US (1)