Clinical trial NCT04309305: Robotic Exoskeleton Assisted Gait Post Stroke
Official title: Functional and Neurophysiological Effects of a Progressive Robot Assisted Gait Intervention Early Post Stroke
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: CVA
Gait, Hemiplegic
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Independence Measure (FIM) (aim 1)
timeFrame: Change from Baseline FIM at 10 weeks
measure: Within-brain functional connectivity (aim 2)
timeFrame: Change from Baseline Within-brain functional connectivity at 10 weeks
measure: TMS recruitment curve slope (aim 3)
timeFrame: Change from Baseline TMS recruitment curve slope at 10 weeks
measure: electroencephalogram (EEG) (aim 3)
timeFrame: Change from Baseline EEG at 10 weeks
measure: electromyography (EMG) (aim 3)
timeFrame: Change from Baseline EMG at 10 weeks
measure: 10MWT (aims 1-3)
timeFrame: Change from Baseline 10MWT at 10 weeks
measure: 6MWT (aims 1-3)
timeFrame: Change from Baseline 6MWT at 10 weeks
measure: TUG (aims 1-3)
timeFrame: Change from Baseline TUG at 10 weeks
measure: structural connectivity (aim 2)
timeFrame: Change from Baseline structural connectivity at 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Karen J. Nolan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kessler Foundation
name: Soha Saleh, PhD
role: PRINCIPAL_INVESTIGATOR
References: