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Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation (RERC)

Primary Purpose

Stroke, Acute

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RE (Robotic Exoskeleton)
SOC (standard of care)
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring hemiplegia, robotic, exoskeleton, gait

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

RE

SOC

RE/SOC

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

Functional Independence Measure (FIM)
a conventional assessment measure of motor function
TUG
time up and go (TUG) test
BBA
Berg Balance Assessment (BBA)
ROM
range of motion (ROM)- conventional assessment performed by a physical therapist
strength
conventional assessment performed by a physical therapist
temporal spatial parameters
collected though motion capture camera system
plantar loading
use of shoe insoles to gather information about foot pressure
electromyography (EMG)
a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
SIS
stroke impact scale (SIS). questionnaire about quality of life post-stroke
LIFE-H
assessment of life habits (LIFE-H). questionnaire about quality of life post-stroke
SSQoL
stroke specific quality of life scale (SSQoL). questionnaire about quality of life post-stroke

Secondary Outcome Measures

Full Information

First Posted
February 3, 2021
Last Updated
February 25, 2021
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04775693
Brief Title
Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation
Acronym
RERC
Official Title
Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
hemiplegia, robotic, exoskeleton, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RE
Arm Type
Experimental
Arm Description
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).
Arm Title
SOC
Arm Type
Active Comparator
Arm Description
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).
Arm Title
RE/SOC
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
RE (Robotic Exoskeleton)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
SOC (standard of care)
Intervention Description
Traditional physical therapist driven gait training.
Primary Outcome Measure Information:
Title
Functional Independence Measure (FIM)
Description
a conventional assessment measure of motor function
Time Frame
6 months
Title
TUG
Description
time up and go (TUG) test
Time Frame
6 months
Title
BBA
Description
Berg Balance Assessment (BBA)
Time Frame
6 months
Title
ROM
Description
range of motion (ROM)- conventional assessment performed by a physical therapist
Time Frame
6 months
Title
strength
Description
conventional assessment performed by a physical therapist
Time Frame
6 months
Title
temporal spatial parameters
Description
collected though motion capture camera system
Time Frame
6 months
Title
plantar loading
Description
use of shoe insoles to gather information about foot pressure
Time Frame
6 months
Title
electromyography (EMG)
Description
a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
Time Frame
6 months
Title
SIS
Description
stroke impact scale (SIS). questionnaire about quality of life post-stroke
Time Frame
6 months
Title
LIFE-H
Description
assessment of life habits (LIFE-H). questionnaire about quality of life post-stroke
Time Frame
6 months
Title
SSQoL
Description
stroke specific quality of life scale (SSQoL). questionnaire about quality of life post-stroke
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J Nolan, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation

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