Robotic Exoskeleton Gait Training During Acute Stroke Rehabilitation

Not Applicable

• Conditions: Stroke, Acute
• Interventions: Other: SOC (standard of care); Device: RE (Robotic Exoskeleton)

• Registration Number: NCT04775693
• Lead Sponsor: Kessler Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-12
• Status Verified: 2021-02
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Study First Posted: 2021-03-01
• Last Update Posted: 2021-03-01
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOC	SOC (standard of care)	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).
RE	RE (Robotic Exoskeleton)	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).
RE/SOC	RE (Robotic Exoskeleton)	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).

Primary Outcome Measures

Name	Time	Method
strength	6 months	conventional assessment performed by a physical therapist
ROM	6 months	range of motion (ROM)- conventional assessment performed by a physical therapist
SIS	6 months	stroke impact scale (SIS). questionnaire about quality of life post-stroke
LIFE-H	6 months	assessment of life habits (LIFE-H). questionnaire about quality of life post-stroke
SSQoL	6 months	stroke specific quality of life scale (SSQoL). questionnaire about quality of life post-stroke
electromyography (EMG)	6 months	a measure of muscle activation (EMG signal) at different phases of gait cycle (swing versus double support).
temporal spatial parameters	6 months	collected though motion capture camera system
Functional Independence Measure (FIM)	6 months	a conventional assessment measure of motor function
TUG	6 months	time up and go (TUG) test
BBA	6 months	Berg Balance Assessment (BBA)
plantar loading	6 months	use of shoe insoles to gather information about foot pressure

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States