PRIORITI-MTF Study- Testing Patient Response to the IDEO

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

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-04-30

Brief Summary

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The goal of the PRIORITI-MTF study is to help determine whether a new type of custom designed brace, called the IDEO ™ along with a physical therapy program, called Return to Run, improves physical function. This brace was developed for wounded warriors who wanted to return to an active lifestyle.

The primary objective of this study is to examine the benefits (and cost-benefits) of an integrated orthotic and rehabilitation program that incorporates the Intrepid Dynamic Exoskeletal Orthosis (IDEO) and the Return to Run (RTR) physical therapy regimen, but designed for scalability in the broader military environment (i.e. beyond San Antonio Military Medical Center where the program was developed)

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Detailed Description

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Conditions

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Leg Injuries Trauma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IDEO brace

Group Type OTHER

IDEO brace

Intervention Type DEVICE

All participants will receive the IDEO brace.

Interventions

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IDEO brace

All participants will receive the IDEO brace.

Intervention Type DEVICE

Other Intervention Names

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IDEO

Eligibility Criteria

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Inclusion Criteria

1. Ages 18-60
2. Currently two or more years out from a traumatic unilateral lower extremity injury at or below the knee
3. Healed fractures and able to fully weight bear
4. Evidence of either:

* Weakness of ankle dorsiflexors and /or plantarflexors resulting from leg injury (defined as less than 4 out of 5 on manual muscle test)
* Limited ankle dorsiflexion (\< 10 degrees) and /or limited ankle plantarflexion (\< 20 degrees) resulting from leg injury
* Mechanical pain with loading to hindfoot/midfoot (\>= 50 mm on a 0-100 mm visual analogue scale assessing average daily pain)
* Ankle or Hindfoot fusion or candidate for ankle or hindfoot fusion
* Candidate for amputation secondary to ankle/foot impairment

Exclusion Criteria

1. Ankle plantarflexion or dorsiflexion weakness as a result of spinal cord injury or central nervous system pathology.
2. Non-ambulatory
3. Surgery on study limb anticipated in next 6 months
4. Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, stroke, renal failure, heart disease, severe anemia)
5. Neurologic, musculoskeletal or other conditions affecting contralateral extremity preventing the study of a healthy control limb
6. Unable or unwilling to participate in two 4-week PT programs
7. Pregnancy
8. Non-English speaking

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No