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Effects of Soft Tissue Lengthening on Gait in Children With Spasticity

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04090892
Enrollment
8
Registered
2019-09-16
Start date
2016-05-10
Completion date
2017-01-31
Last updated
2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Spasticity

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.

Interventions

PROCEDUREselective 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.

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 21 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Kinematic Change is being assessedOutcomes measures will be administered 4 weeks before surgery as a baselineLower extremity joint angles at baseline before

Secondary

MeasureTime frameDescription
Gross Motor Function Measure - Change is being assessedOutcomes measures will be administered 4 weeks before surgery as a baselineMeasures level of gross motor ability

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026