Clinical trial NCT04775693: Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation
Official title: Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute
Keywords: hemiplegia
robotic
exoskeleton
gait
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 96
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Functional Independence Measure (FIM)
timeFrame: 6 months
measure: TUG
timeFrame: 6 months
measure: BBA
timeFrame: 6 months
measure: ROM
timeFrame: 6 months
measure: strength
timeFrame: 6 months
measure: temporal spatial parameters
timeFrame: 6 months
measure: plantar loading
timeFrame: 6 months
measure: electromyography (EMG)
timeFrame: 6 months
measure: SIS
timeFrame: 6 months
measure: LIFE-H
timeFrame: 6 months
measure: SSQoL
timeFrame: 6 months
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
References: