Effects of Soft Tissue Lengthening on Gait in Children With Spasticity

NCT04090892 | Completed

• 1 other identifier: STU 042014-068
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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. 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. 2.Identify changes in impairments and activity limitations following selective percutaneous myofascial lengthening .
3. 3.Identify changes in a family or caregivers perceived quality of life after their child's selective percutaneous myofascial lengthening .

Conditions

Muscle Spasticity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Gross Motor Function Measure - Change is being assessed

  Outcomes measures will be administered 4 weeks before surgery as a baseline

• Gross Motor Function Measure - Change is being assessed

  Outcomes measures will be administered at 6 weeks after surgery to assess short term change

• Gross Motor Function Measure - Change is being assessed

  Outcomes measures will be administered at 6 months after surgery to assess long term change.

Study Arms (1)

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

Interventions

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.

Persons with spasticity 4.0-20.11 years

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children between the ages of 4.0 and 20.11 years

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan D Simpkins, EdD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: September 16, 2019
• Study Start: May 10, 2016
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: September 16, 2019

Record last verified: 2019-02

Locations

US (1)