Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2018-01-17

Brief Summary

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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).

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Detailed Description

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Conditions

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Cerebrovascular Accident (CVA) Stroke Hemiplegia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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All Enrolled Subjects

All enrolled subjects will receive gait training with the Indego.

Group Type EXPERIMENTAL

Indego Exoskeleton

Intervention Type DEVICE

Six study sessions including five Indego training sessions over two weeks.

Interventions

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Indego Exoskeleton

Six study sessions including five Indego training sessions over two weeks.

Intervention Type DEVICE

Eligibility Criteria

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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

* Pregnancy
* Colostomy bag
* Uncontrolled/untreated hyper- or hypotension

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No