Robotic Exoskeleton Assisted Gait Post Stroke

Gait, Hemiplegic Clinical Trial

— RE-Assist  

Official title:

Functional and Neurophysiological Effects of a Progressive Robot Assisted Gait Intervention Early Post Stroke

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04309305
• Other study ID #: R-1073-19
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: January 30, 2020
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2021
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current investigation takes advantage of both a progressive and adaptive assist-as-needed massed practice and time-sensitive neuroplasticity through exoskeleton assisted walking in order to induce greater recovery-oriented CNS plasticity and consequent gains in more independent walking.

Description:

The purpose of this research study is to assess whether using a wearable device, called the robotic exoskeleton (RE), can be helpful in improving recovery of walking in adults who have recently had a stroke. The study will compare the walking abilities of people who went through standard of care treatment after a stroke to those who used the robotic exoskeleton as part of their rehabilitation. This study will also look at the effects walking in the RE has on brain activity. The name of the robotic exoskeleton that is being used in this study is the EksoTM.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: September 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Stroke survivors < 4 weeks from most recent stroke.
• Age: 21- 80 years
• Unilateral hemiparesis
• Medical clearance by the Medical Director
• Be able to physically fit into the exoskeleton device.
• Have joint range of motion within normal functional limits for ambulation.
• Have sufficient strength to use the hemiwalker, cane or walker (etc. assistive device) while wearing the RE.
• 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.
• Adequate cognitive function to give informed consent, understand the training, instructions, use investigational devices and give adequate feedback.
• No history of injury or pathology to the unaffected limb.
• physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs.

Exclusion Criteria:

• 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.
• 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 or joint contracture that would interfere with walking in the RE and limits normal ROM during ambulation with assistive devices.
• Neuromuscular 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 ROM of the lower limbs (e.g., knee replacement, fixed contractures, inflammation)
• Any metal implants that are NOT MRI-compatible

Related Conditions & MeSH terms

• CVA
• Gait Disorders, Neurologic
• Gait, Hemiplegic

Intervention

Device:
• EksoGT™, Ekso Bionics, Berkley, CA, USA
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.

Other:
• Standard of Care
Standard gait therapy provided by licensed physical therapists post stroke.
• No Intervention
Testing Only

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Independence Measure (FIM) (aim 1)	a conventional assessment measure of motor function	Change from Baseline FIM at 10 weeks
Primary	Within-brain functional connectivity (aim 2)	fMRI connectivity between selected regions of interest within the sensorimotor and attention networks.	Change from Baseline Within-brain functional connectivity at 10 weeks
Primary	TMS recruitment curve slope (aim 3)	A recruitment curve created using measure of primary motor cortex Motor Evoked Potential (MEP) at several stimulation thresholds.	Change from Baseline TMS recruitment curve slope at 10 weeks
Primary	electroencephalogram (EEG) (aim 3)	a measure of brain activation at different phases of gait cycle (swing versus double support).	Change from Baseline EEG at 10 weeks
Primary	electromyography (EMG) (aim 3)	a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).	Change from Baseline EMG at 10 weeks
Primary	10MWT (aims 1-3)	10 meters walking test to evaluate walking speedafter stroke and in response to the intervention.	Change from Baseline 10MWT at 10 weeks
Primary	6MWT (aims 1-3)	6 minutes walking test to evaluate endurancein connectivity after stroke and in response to the intervention.	Change from Baseline 6MWT at 10 weeks
Primary	TUG (aims 1-3)	time up and go (TUG) test	Change from Baseline TUG at 10 weeks
Primary	structural connectivity (aim 2)	Diffusion Tensor Imaging (DTI) and fractal dimensions (FD) measures of structural connectivity	Change from Baseline structural connectivity at 10 weeks