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Completed

NCT Number: NCT04090892

Effects of Soft Tissue Lengthening on Gait in Children With Spasticity

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.

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Key information

Age range

4 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Medical Center

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

selective percutaneous muscle release

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Effects of Selective Percutaneous Muscle Lengthening on Gait in Children With Spasticity

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2019
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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