Muscle SpasticityNCT04090892
Effects of Soft Tissue Lengthening on Gait in Children With Spasticity
An observational study of Muscle Spasticity, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Muscle Spasticity
- What is being tested?
- selective percutaneous muscle release
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2016to 31 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children between the ages of 4.0 and 20.11 years
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- 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.
- Identify changes in impairments and activity limitations following selective percutaneous myofascial lengthening .
- 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.
- Conditions
- Muscle Spasticity
- Being tested
- selective percutaneous muscle release
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective percutaneous muscle releaseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: selective percutaneous muscle release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic Change is being assessed
Lower extremity joint angles at baseline before
Measured: Outcomes measures will be administered 4 weeks before surgery as a baseline
Kinematic Change is being assessed
Lower extremity joint angles after surgery
Measured: 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
Measured: 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
Measures level of gross motor ability
Measured: 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
Measured: 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
Measured: Outcomes measures will be administered at 6 months after surgery to assess long term change.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start10 May 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Simpkins, University of Texas Southwestern Medical Center
- Investigators
- Susan D Simpkins, EdD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090892
- Sponsor's protocol ID
- STU 042014-068
- Status last verified
- Feb 2019
- First submitted
- 6 Aug 2014
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Selective Percutaneous Muscle Lengthening on Gait in Children With Spasticity
- ClinicalTrials.gov ID
- NCT04090892
- Acronym / sponsor ID
- STU 042014-068
- Conditions
- Muscle Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Identify changes in impairments and activity limitations following selective percutaneous myofascial lengthening .
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with spasticity 4.0-20.11 years | – | Procedure: selective percutaneous muscle releaseStudy personnel are not carrying out the surgical intervention but are assessing the outcomes of the surgery on gait and motor function. |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children between the ages of 4.0 and 20.11 years
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selective percutaneous muscle releaseChildren 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. | Procedure or surgery | Persons with spasticity 4.0-20.11 years |
Primary outcome
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
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
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
3 secondary outcomes
Gross Motor Function Measure - Change is being assessed
Time frame: Outcomes measures will be administered 4 weeks before surgery as a baseline
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
Related trials for Muscle Spasticity
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan D Simpkins, EdD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Spasticity, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic Change is being assessed (time frame: Outcomes measures will be administered 4 weeks before surgery as a baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.