Effects of Soft Tissue Lengthening on Gait in Children With Spasticity

Muscle Spasticity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04090892
• Other study ID #: STU 042014-068
• Status: Completed
• Start date: May 10, 2016
• Est. completion date: January 31, 2017

Study information

• Verified date: February 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematic Change is being assessed	Lower extremity joint angles at baseline before	Outcomes measures will be administered 4 weeks before surgery as a baseline
Primary	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
Primary	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	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
Secondary	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
Secondary	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.