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Trial Outcomes & Findings for Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy (NCT NCT02699554)

NCT ID: NCT02699554

Last Updated: 2022-05-09

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

55 participants

Primary outcome timeframe

6-months after individual's orthopaedic surgery

Results posted on

2022-05-09

Participant Flow

539 children with bilateral cerebral palsy eligible for orthopedic surgery were screened. 122 were invited to participate in the study, 45 did not meet the study criteria, 22 did not respond, and 55 participated in the study.

Participant milestones

Participant milestones
Measure
Orthopaedic Surgery
Single-event multilevel surgery
Overall Study
STARTED
55
Overall Study
COMPLETED
46
Overall Study
NOT COMPLETED
9

Reasons for withdrawal

Reasons for withdrawal
Measure
Orthopaedic Surgery
Single-event multilevel surgery
Overall Study
Lost to Follow-up
9

Baseline Characteristics

Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Orthopaedic Surgery
n=55 Participants
Single-event multilevel surgery
Age, Continuous
10.5 years
STANDARD_DEVIATION 3.1 • n=5 Participants
Sex: Female, Male
Female
19 Participants
n=5 Participants
Sex: Female, Male
Male
36 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
53 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
Race (NIH/OMB)
White
47 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
Gait Deviation Index (GDI)
68.2 z-score
STANDARD_DEVIATION 12.1 • n=5 Participants
Dynamic Motor Control (DMC)
80.5 normalized z-score
STANDARD_DEVIATION 9.5 • n=5 Participants

PRIMARY outcome

Timeframe: 6-months after individual's orthopaedic surgery

Population: 32 of the 55 participants returned for 6-month post-operative gait analysis

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.

Outcome measures

Outcome measures
Measure
Orthopaedic Surgery
n=32 Participants
Single-event multilevel surgery
Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery
-2.4 normalized z-score
Standard Deviation 6.0

PRIMARY outcome

Timeframe: 1-year after individual's orthopaedic surgery

Population: 46 of the 55 participants returned for 12-month post-operative gait analysis

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.

Outcome measures

Outcome measures
Measure
Orthopaedic Surgery
n=46 Participants
Single-event multilevel surgery
Change in Walk Dynamic Motor Control Index 1-year After Orthopaedic Surgery
-2.7 normalized z-score
Standard Deviation 6.7

SECONDARY outcome

Timeframe: 6-months after individual's orthopaedic surgery

Population: 32 of the 55 participants returned for 6-month post-operative gait analysis

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.

Outcome measures

Outcome measures
Measure
Orthopaedic Surgery
n=32 Participants
Single-event multilevel surgery
Change in Gait Deviation Index 6-months After Orthopaedic Surgery
2.8 normalized z-score
Standard Deviation 9.2

SECONDARY outcome

Timeframe: 1-year after individual's orthopaedic surgery

Population: 46 of the 55 participants returned for 12-month post-operative gait analysis

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.

Outcome measures

Outcome measures
Measure
Orthopaedic Surgery
n=46 Participants
Single-event multilevel surgery
Change in Gait Deviation Index 1-year After Orthopaedic Surgery
2.1 normalized z-score
Standard Deviation 8.1

Adverse Events

Orthopaedic Surgery

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katherine Steele

University of Washington

Phone: 206-685-2390

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place