NCT03054064

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the Indego exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular Accident (CVA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

February 21, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2017

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2018

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 7, 2020

Completed
Last Updated

April 7, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

February 13, 2017

Results QC Date

April 17, 2019

Last Update Submit

March 24, 2020

Conditions

Cerebrovascular Accident (CVA)StrokeHemiplegia

Outcome Measures

Primary Outcomes (1)

  • Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events

    Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events

    2 weeks

Secondary Outcomes (4)

  • Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale

    2 weeks

  • Activity Measured by Functional Ambulation Category

    2 weeks

  • Gait Speed (Without Indego) Measured With 10 Meter Walk Test

    2 weeks

  • Pain Measured With Face, Legs, Activity, Cry, Consolability Scale

    2 weeks

Study Arms (1)

All Enrolled Subjects

EXPERIMENTAL

All enrolled subjects will receive gait training with the Indego.

Device: Indego Exoskeleton

Interventions

Indego ExoskeletonDEVICE

Six study sessions including five Indego training sessions over two weeks.

All Enrolled Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Height 5'1" to 6'3" (acceptable height may vary by a few inches depending on femur length)
  • Weight 250 pounds or less
  • History of one sided ischemic or hemorrhagic stroke with resultant hemiparesis
  • Manual Muscle Test (MMT) 4/5 in at least upper extremity
  • No restrictions on time since stroke (acuity), but all subjects need to be cleared by MD for locomotor training
  • No other brain abnormalities or neurological diseases/disorders
  • Has not been diagnosed with more than one stroke
  • Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait
  • Skin intact where interfaces with Indego device
  • Modified Ashworth Scale (MAS) for spasticity 3 or less in the lower extremities
  • Absence of complicating physical or mental conditions as determined by MD that would preclude the individual from safely participating in gait training
  • Must be able to follow directions and communicate basic needs, demonstrated by a Mini- Mental State Exam (MMSE) score of 18 or greater

You may not qualify if:

  • Pregnancy
  • Colostomy bag
  • Uncontrolled/untreated hyper- or hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cedars-Sinai Health System

Los Angeles, California, 90048, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Rehabilitation Institute of Chicago (Shirley Ryan AbilityLab)

Chicago, Illinois, 60611, United States

Location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

St. Charles Hospital

Port Jefferson, New York, 11777, United States

Location

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

Sheltering Arms Physical Rehabilitation Centers

Mechanicsville, Virginia, 23116, United States

Location

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ryan J. Farris, Ph.D., P.E.
Organization
Parker Hannifin Corporation
ryan.farris@parker.com
2168963335

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 15, 2017

Study Start

February 21, 2017

Primary Completion

December 28, 2017

Study Completion

January 17, 2018

Last Updated

April 7, 2020

Results First Posted

April 7, 2020

Record last verified: 2020-03

Locations

US(7)