Effects of Soft Tissue Lengthening on Gait in Children With Spasticity
NCT ID: NCT04090892
Last Updated: 2019-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
8 participants
OBSERVATIONAL
2016-05-10
2017-01-31
Brief Summary
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1. Compare gait kinematics and kinetics in children and young adults with lower extremity spasticity before and after selective percutaneous myofascial lengthening to determine the effects of this procedure on functional mobility.
2. Identify changes in impairments and activity limitations following selective percutaneous myofascial lengthening .
3. Identify changes in a family or caregivers perceived quality of life after their child's selective percutaneous myofascial lengthening .
The aim of this study is to identify and describe the specific changes in secondary musculoskeletal impairments, activity limitations, and gait kinematics and kinetics after a selective percutaneous myofascial lengthening procedure. Gait kinematics and kinetics includes the motion of joints and body segments, and force and power, at each lower extremity joint, respectively. The results of this study will provide preliminary information on how this form of soft tissue lengthening affects functional mobility skills in children with spasticity. The study is expected to run for two years and the primary study endpoint is when participants have completed their second post- operative data collection session.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Persons with spasticity 4.0-20.11 years
Study personnel are not carrying out the surgical intervention but are assessing the outcomes of the surgery on gait and motor function.
selective percutaneous muscle release
Children will be evaluated before and two times after they undergo a selective percutaneous myofascial release. Investigators make no determination about the need for the surgery or which muscles are released, nor do they participate in the surgery. The investigators are assess outcomes on gait and motor function.
Interventions
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selective percutaneous muscle release
Children will be evaluated before and two times after they undergo a selective percutaneous myofascial release. Investigators make no determination about the need for the surgery or which muscles are released, nor do they participate in the surgery. The investigators are assess outcomes on gait and motor function.
Eligibility Criteria
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Inclusion Criteria
* Between the ages of 4.0 and 20.11 years old,
* Lower extremity spasticity,
* Able to ambulate 50 feet without a rest, with or without an assistive device, and with or without ankle foot orthoses (AFOs) and
* Able to follow one step directions.
Exclusion Criteria
* Lower extremity orthopedic surgery within 6 months of the scheduled selective percutaneous myofascial lengthening procedure,
* Visual impairment that interferes with maintaining a straight path while ambulating,
* Uncontrolled seizure disorder
* A change in medication that affects spasticity or ability to follow one step directions within three months of the scheduled selective percutaneous myofascial lengthening procedure.
4 Years
21 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Susan Simpkins
Associate Professor
Principal Investigators
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Susan D Simpkins, EdD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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Children's Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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STU 042014-068
Identifier Type: -
Identifier Source: org_study_id
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