Effects of Soft Tissue Lengthening on Gait in Children With Spasticity

Effects of Selective Percutaneous Muscle 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.

Study Overview

• Status: Completed
• Conditions: Muscle Spasticity
• Intervention / Treatment: Procedure: selective percutaneous muscle release

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children between the ages of 4.0 and 20.11 years

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematic Change is being assessed	Lower extremity joint angles at baseline before	Outcomes measures will be administered 4 weeks before surgery as a baseline
Kinematic Change is being assessed	Lower extremity joint angles after surgery	Outcomes measures will be administered then at 6 weeks after surgery to assess short term change
Kinematic Change is being assessed	Lower extremity joint angles after surgery	Outcomes measures will be administered 6 months after surgery to assess long term change.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Motor Function Measure - Change is being assessed	Measures level of gross motor ability	Outcomes measures will be administered 4 weeks before surgery as a baseline
Gross Motor Function Measure - Change is being assessed	Measures level of gross motor ability	Outcomes measures will be administered at 6 weeks after surgery to assess short term change
Gross Motor Function Measure - Change is being assessed	Measures level of gross motor ability	Outcomes measures will be administered at 6 months after surgery to assess long term change.

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Susan D Simpkins, EdD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 10, 2016
• Primary Completion (ACTUAL): January 31, 2017
• Study Completion (ACTUAL): January 31, 2017

Study Registration Dates

• First Submitted: August 6, 2014
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (ACTUAL): September 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: STU 042014-068