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Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

P

Parker Hannifin

Status

Completed

Conditions

Stroke
Cerebrovascular Accident (CVA)
Hemiplegia

Treatments

Device: Indego Exoskeleton

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03054064
PHIND_CVA01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of the Indego exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular Accident (CVA).

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Height 5'1" to 6'3" (acceptable height may vary by a few inches depending on femur length)
  • Weight 250 pounds or less
  • History of one sided ischemic or hemorrhagic stroke with resultant hemiparesis
  • Manual Muscle Test (MMT) 4/5 in at least upper extremity
  • No restrictions on time since stroke (acuity), but all subjects need to be cleared by MD for locomotor training
  • No other brain abnormalities or neurological diseases/disorders
  • Has not been diagnosed with more than one stroke
  • Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait
  • Skin intact where interfaces with Indego device
  • Modified Ashworth Scale (MAS) for spasticity 3 or less in the lower extremities
  • Absence of complicating physical or mental conditions as determined by MD that would preclude the individual from safely participating in gait training
  • Must be able to follow directions and communicate basic needs, demonstrated by a Mini- Mental State Exam (MMSE) score of 18 or greater

Exclusion criteria

  • Failure to meet all inclusion criteria
  • Pregnancy
  • Colostomy bag
  • Uncontrolled/untreated hyper- or hypotension

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

All Enrolled Subjects
Experimental group
Description:
All enrolled subjects will receive gait training with the Indego.
Treatment:
Device: Indego Exoskeleton

Trial documents
1

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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