Cerebral PalsyNCT02699554
Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy
An observational study of Cerebral Palsy, run by University of Washington at 1 site in United States.
Trial summary
Impaired neuromuscular control hinders movement for individuals with cerebral palsy and other neurological disorders. In this research, the investigators are developing new tools to quantify impaired neuromuscular control in cerebral palsy and evaluate changes after one of the most common treatments, orthopaedic… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Single-event multilevel surgery
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals with cerebral palsy, diplegia subtype, with mild or moderate impairment, Gross Motor Function Classification System (GMFCS) Levels I-III, between the ages of 6 - 18.
Who may be able to join
- Diplegic cerebral palsy
- Mild or Moderate Impairment, Gross Motor Function Classification System (GMFCS) Levels I-III
- Will receive follow-up care and physical therapy within the Gillette Children's Specialty Healthcare system
Who cannot join
- Botulinum toxin injections, baclofen, or other similar treatments in the 3 months prior to pre-operative gait analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101
About this study
Impaired neuromuscular control hinders movement for individuals with cerebral palsy and other neurological disorders. In this research, the investigators are developing new tools to quantify impaired neuromuscular control in cerebral palsy and evaluate changes after one of the most common treatments, orthopaedic surgery. The results from this research will empower clinicians to identify patient-specific factors that contribute to impaired movement and improve treatment and quality of life.
Read the detailed description
The long-term goals of this research are to quantify patient-specific changes in neuromuscular control in order to optimize treatment planning and improve mobility for individuals with cerebral palsy (CP). As a first step, the aims of this proposal are to evaluate neuromuscular control before and after one of the most common treatments for individuals with CP, orthopaedic surgery. The investigators will evaluate if patient-specific measures of neuromuscular control, based upon the framework of muscle synergies, can predict improvements in walking ability after surgery. Further, investigators will determine whether neuromuscular control changes after surgery and if these changes contribute to improvements in movement. To achieve these goal the investigators will implement and test new tools to quantify neuromuscular control which integrate clinical gait analysis and two computational techniques: synergy analysis and dynamic musculoskeletal simulation. This research will provide the foundation to use measures of altered neuromuscular control to inform treatment planning, develop alternative treatments, and improve mobility in CP and other neurologic disorders.
- Conditions
- Cerebral Palsy
- Being tested
- Single-event multilevel surgery
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-event multilevel surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Orthopaedic surgery | Not described Receives: Procedure: Single-event multilevel surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery
The Walk Dynamic Motor Control Index (Walk DMC) is a specific measurement calculated from electromyography during gait using nonnegative matrix factorization. A value of 100 indicates complexity of neuromuscular control similar to typically-developing peers and each 10 point deviation represents one standard deviation from typically-developing peers. Thus, a value of 80 would indicate that an individual's muscle coordination during gait is two standard deviations below the complexity of unimpaired individuals.
Measured: 6-months after individual's orthopaedic surgery
Change in Walk Dynamic Motor Control Index 1-year After Orthopaedic Surgery
The Walk Dynamic Motor Control Index (Walk DMC) is a specific measurement calculated from electromyography during gait using nonnegative matrix factorization. A value of 100 indicates complexity of neuromuscular control similar to typically-developing peers and each 10 point deviation represents one standard deviation from typically-developing peers. Thus, a value of 80 would indicate that an individual's muscle coordination during gait is two standard deviations below the complexity of unimpaired individuals.
Measured: 1-year after individual's orthopaedic surgery
Secondary outcomes (2)
Change in Gait Deviation Index 6-months After Orthopaedic Surgery
The Gait Deviation Index is a specific measurement which uses kinematics measured from instrumented gait analysis to compare an individual's gait pattern to typically-developing controls. A value of 100 indicates kinematics similar to unimpaired individuals while each 10 point deviation represents one standard deviation from unimpaired gait. Thus, a value of 80 would indicate that an individual's gait kinematics are on average two standard deviations from unimpaired gait.
Measured: 6-months after individual's orthopaedic surgery
Change in Gait Deviation Index 1-year After Orthopaedic Surgery
The Gait Deviation Index is a specific measurement which uses kinematics measured from instrumented gait analysis to compare an individual's gait pattern to typically-developing controls. A value of 100 indicates kinematics similar to unimpaired individuals while each 10 point deviation represents one standard deviation from unimpaired gait. Thus, a value of 80 would indicate that an individual's gait kinematics are on average two standard deviations from unimpaired gait.
Measured: 1-year after individual's orthopaedic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 55 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Gillette Children's Specialty Healthcare
- Responsible party
- Principal investigator, Katherine Steele, University of Washington
- Investigators
- Katherine M Steele, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02699554
- Sponsor's protocol ID
- 44170
- Other IDs
- 1R01NS091056-01A1
- Status last verified
- May 2022
- First submitted
- 20 Jan 2016
- Last updated
- 9 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02699554
- Acronym / sponsor ID
- 44170
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Gillette Children's Specialty Healthcare
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Posted 9 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Impaired neuromuscular control hinders movement for individuals with cerebral palsy and other neurological disorders. In this research, the investigators are developing new tools to quantify impaired neuromuscular control in cerebral palsy and evaluate changes after one of the most common treatments, orthopaedic surgery. The results from this research will empower clinicians to identify patient-specific factors that contribute to impaired movement and improve treatment and quality of life.
Detailed description
The long-term goals of this research are to quantify patient-specific changes in neuromuscular control in order to optimize treatment planning and improve mobility for individuals with cerebral palsy (CP). As a first step, the aims of this proposal are to evaluate neuromuscular control before and after one of the most common treatments for individuals with CP, orthopaedic surgery. The investigators will evaluate if patient-specific measures of neuromuscular control, based upon the framework of muscle synergies, can predict improvements in walking ability after surgery. Further, investigators will determine whether neuromuscular control changes after surgery and if these changes contribute to improvements in movement. To achieve these goal the investigators will implement and test new tools to quantify neuromuscular control which integrate clinical gait analysis and two computational techniques: synergy analysis and dynamic musculoskeletal simulation. This research will provide the foundation to use measures of altered neuromuscular control to inform treatment planning, develop alternative treatments, and improve mobility in CP and other neurologic disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthopaedic surgery | – | Procedure: Single-event multilevel surgery |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals with cerebral palsy, diplegia subtype, with mild or moderate impairment, Gross Motor Function Classification System (GMFCS) Levels I-III, between the ages of 6 - 18.
Key inclusion criteria (3 listed)
- Diplegic cerebral palsy
- Mild or Moderate Impairment, Gross Motor Function Classification System (GMFCS) Levels I-III
- Will receive follow-up care and physical therapy within the Gillette Children's Specialty Healthcare system
Key exclusion criteria (1 listed)
- Botulinum toxin injections, baclofen, or other similar treatments in the 3 months prior to pre-operative gait analysis
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 |
|---|---|---|
| Single-event multilevel surgery | Procedure or surgery | Orthopaedic surgery |
Primary outcome
Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery
Time frame: 6-months after individual's orthopaedic surgery
The Walk Dynamic Motor Control Index (Walk DMC) is a specific measurement calculated from electromyography during gait using nonnegative matrix factorization. A value of 100 indicates complexity of neuromuscular control similar to typically-developing peers and each 10 point deviation represents one standard deviation from typically-developing peers. Thus, a value of 80 would indicate that an individual's muscle coordination during gait is two standard deviations below the complexity of unimpaired individuals.
Change in Walk Dynamic Motor Control Index 1-year After Orthopaedic Surgery
Time frame: 1-year after individual's orthopaedic surgery
The Walk Dynamic Motor Control Index (Walk DMC) is a specific measurement calculated from electromyography during gait using nonnegative matrix factorization. A value of 100 indicates complexity of neuromuscular control similar to typically-developing peers and each 10 point deviation represents one standard deviation from typically-developing peers. Thus, a value of 80 would indicate that an individual's muscle coordination during gait is two standard deviations below the complexity of unimpaired individuals.
2 secondary outcomes
Change in Gait Deviation Index 6-months After Orthopaedic Surgery
Time frame: 6-months after individual's orthopaedic surgery
Change in Gait Deviation Index 1-year After Orthopaedic Surgery
Time frame: 1-year after individual's orthopaedic surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Katherine M Steele, PhD principal investigator
University of Washington
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 Cerebral Palsy, run by University of Washington 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 3 inclusion and 1 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 9 May 2022. 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?
Yes. Results are posted in the registry (first posted 9 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery (time frame: 6-months after individual's orthopaedic surgery). The study lists 2 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 9 May 2022.