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Effects of Soft Tissue Lengthening on Gait in Children With Spasticity

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ClinicalTrials.gov Identifier: NCT04090892
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Susan Simpkins, University of Texas Southwestern Medical Center

Brief Summary:

This research project is being conducted to investigate changes in secondary impairments, functional mobility skills, and gait variables in children with spasticity following selective percutaneous myofascial lengthening. The research project proposed here will be the first to use instrumented three-dimensional motion analysis to investigate the effects of selective percutaneous myofascial lengthening on gait kinematics and kinetics. The objectives of the study are to:

  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.


Condition or disease Intervention/treatment
Muscle Spasticity Procedure: selective percutaneous muscle release

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Selective Percutaneous Muscle Lengthening on Gait in Children With Spasticity
Actual Study Start Date : May 10, 2016
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Group/Cohort Intervention/treatment
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.
Procedure: 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.




Primary Outcome Measures :
  1. Kinematic Change is being assessed [ Time Frame: Outcomes measures will be administered 4 weeks before surgery as a baseline ]
    Lower extremity joint angles at baseline before

  2. Kinematic Change is being assessed [ Time Frame: Outcomes measures will be administered then at 6 weeks after surgery to assess short term change ]
    Lower extremity joint angles after surgery

  3. Kinematic Change is being assessed [ Time Frame: Outcomes measures will be administered 6 months after surgery to assess long term change. ]
    Lower extremity joint angles after surgery


Secondary Outcome Measures :
  1. Gross Motor Function Measure - Change is being assessed [ Time Frame: Outcomes measures will be administered 4 weeks before surgery as a baseline ]
    Measures level of gross motor ability

  2. Gross Motor Function Measure - Change is being assessed [ Time Frame: Outcomes measures will be administered at 6 weeks after surgery to assess short term change ]
    Measures level of gross motor ability

  3. Gross Motor Function Measure - Change is being assessed [ Time Frame: Outcomes measures will be administered at 6 months after surgery to assess long term change. ]
    Measures level of gross motor ability



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Ages Eligible for Study:   4 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children between the ages of 4.0 and 20.11 years
Criteria

Inclusion Criteria:

  • Scheduled for an selective percutaneous myofascial lengthening procedure,
  • 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:

  • Botox injections into any lower extremity muscle within three months of the scheduled selective percutaneous myofascial lengthening procedure,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090892


Locations
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United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Susan D Simpkins, EdD UT Southwestern Medical Center

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Responsible Party: Susan Simpkins, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04090892     History of Changes
Other Study ID Numbers: STU 042014-068
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms