Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation (RERC)

February 25, 2021 updated by: Kessler Foundation
The objective of this RCT is to explore the clinical, functional and neurophysiological effectiveness of RE-assisted (Robotic Exoskeleton) early intervention gait therapy in stroke patients during inpatient and outpatient stroke rehabilitation as compared to traditional gait training in three groups: 1) RE; 2) RE-Standard of Care (SOC) and 3) SOC. We will evaluate the short and long-term effects on functional mobility, clinical, neurophysiological, community participation and quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stroke survivors < 4 weeks from most recent stroke.
  • Age: 21- 80 years
  • Unilateral hemiparesis
  • Medical clearance by a Kessler Institute for Rehabilitation physician.
  • Be able to physically fit into the exoskeleton device.
  • Be able to tolerate upright standing for 30 minutes.
  • Have joint range of motion within normal functional limits for ambulation.
  • Have sufficient strength to use the hemiwalker, bilateral canes or walker while wearing the RE.
  • Have stable blood pressure; no diagnosis of persistent orthostatic hypotension (blood pressure drop of more than 30 millimeters of Mercury in body weight support system).
  • Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation, e.g. can follow directions as determined by a Kessler Institute for Rehabilitation physician or physical therapist.
  • No history of injury or pathology to the unaffected limb.

Exclusion Criteria:

  • Unable to physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs.

    • Joint contracture or spasticity of any limb that limits normal ROM during ambulation with assistive devices.
    • Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity).
    • Skin issues that would prevent wearing the device.
    • Pressure sore stage 2 or higher located in an area that would negatively affect weight bearing, harness fit, or therapist assistance.
    • Pre-existing condition that caused exercise intolerance.(Documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure)
    • Hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
    • Severe cognitive or psychiatric problems as well as incontinence might be contraindications to start training with a RE.
    • History of severe cardiac disease such as myocardial infarction, congestive heart failure.
    • Uncontrolled seizure disorder.
    • Uncontrolled spasticity that would interfere with walking in the RENeuromuscular or neurological pathologies (e.g., Parkinson's disease, spinal cord injury, or traumatic brain injury with evidence of motor weakness and multiple sclerosis) that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs
    • Orthopedic pathologies or history that will interfere with ambulation or limit the range of motion of the lower limbs (e.g., knee replacement, fixed contractures, inflammation)
    • Pregnant as confirmed by pregnancy test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RE
Participants use the robotic exoskeleton (RE) in addition to their standard of care gait training as both an inpatient (2 days a week RE) and an outpatient (3 days a week RE).
Device: RE (Robotic Exoskeleton)
Participants will continue to receive their prescribed standard of care physical therapy/gait training. They will also utilize the robotic exoskeleton twice a week during their inpatient stay and 3 times a week for 5 weeks as an outpatient (for outpatient, only if in the RE group). The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking. It uses sensors and participant motion to move. A licensed physical therapist will be assisting participants as they use the device.
Active Comparator: SOC
Participants receive standard of care gait training only as both an inpatient (at least 2 days a week) and an outpatient (at least 3 days a week).
Other: SOC (standard of care)
Traditional physical therapist driven gait training.
Experimental: RE/SOC
Participants use the robotic exoskeleton (RE) in addition to their standard of care gait training as an inpatient (2 days a week RE) and standard of care only as an outpatient (at least 3 days a week).
Device: RE (Robotic Exoskeleton)
Participants will continue to receive their prescribed standard of care physical therapy/gait training. They will also utilize the robotic exoskeleton twice a week during their inpatient stay and 3 times a week for 5 weeks as an outpatient (for outpatient, only if in the RE group). The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking. It uses sensors and participant motion to move. A licensed physical therapist will be assisting participants as they use the device.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Independence Measure (FIM)
Time Frame: 6 months
a conventional assessment measure of motor function
6 months
TUG
Time Frame: 6 months
time up and go (TUG) test
6 months
BBA
Time Frame: 6 months
Berg Balance Assessment (BBA)
6 months
ROM
Time Frame: 6 months
range of motion (ROM)- conventional assessment performed by a physical therapist
6 months
strength
Time Frame: 6 months
conventional assessment performed by a physical therapist
6 months
temporal spatial parameters
Time Frame: 6 months
collected though motion capture camera system
6 months
plantar loading
Time Frame: 6 months
use of shoe insoles to gather information about foot pressure
6 months
electromyography (EMG)
Time Frame: 6 months
a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
6 months
SIS
Time Frame: 6 months
stroke impact scale (SIS). questionnaire about quality of life post-stroke
6 months
LIFE-H
Time Frame: 6 months
assessment of life habits (LIFE-H). questionnaire about quality of life post-stroke
6 months
SSQoL
Time Frame: 6 months
stroke specific quality of life scale (SSQoL). questionnaire about quality of life post-stroke
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kessler Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen J Nolan, PhD, Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R-911-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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