Trial Outcomes & Findings for Precision Gait Retraining for Children With Cerebral Palsy (NCT NCT04717323)

Last Updated: 2022-03-04

Results Overview

Measures the accuracy of identifying heel strike and toe off timing in % error when comparing measures from wearable sensors vs. motion capture

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

1 day

Results posted on

2022-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Gait with and without pelvic assistance	Controls Gait with no pelvic assistance
Overall Study STARTED	0	10
Overall Study COMPLETED	0	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Precision Gait Retraining for Children With Cerebral Palsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Gait with and without pelvic assistance	Controls n=10 Participants Gait with no pelvic assistance	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	10 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	—	27.3 years STANDARD_DEVIATION 2.8 • n=7 Participants	27.3 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	—	5 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	—	5 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	10 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	—	8 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	10 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Analysis was conducted for control participants that completed the study procedure.

Measures the accuracy of identifying heel strike and toe off timing in % error when comparing measures from wearable sensors vs. motion capture

Outcome measures

Outcome measures
Measure	Patients Gait with and without pelvic assistance	Controls n=10 Participants Gait with no pelvic assistance
Gait Metric Accuracy	—	2.01 percentage of error Standard Deviation 1.44

PRIMARY outcome

Timeframe: 1 day

Population: Analysis was conducted for control participants that completed the study procedure

Difference (in degrees) between pelvis range of motion during walking as detected by wearable sensors and motion capture

Outcome measures

Outcome measures
Measure	Patients Gait with and without pelvic assistance	Controls n=10 Participants Gait with no pelvic assistance
Pelvis Range of Motion During Walking	—	1.40 degrees Standard Deviation 0.60

PRIMARY outcome

Timeframe: 1 day

Population: Analysis was not conducted since patient participants in need of EMG biofeedback were not recruited.

Measures electromyographic (EMG) signals of trunk and lower limb muscles during gait which are necessary for designing and implementing a mobile pelvic assist device (mPAD) system with biofeedback

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 day

Population: Analysis was not conducted since patient participants assigned to the pelvic assistance intervention were not recruited.

Structured interviews will be used to grade the perception of difficulty in using the technology

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 day

Population: Analysis was conducted for control participants that completed the study procedure

Difference (in degrees) between trunk range of motion during walking as detected by wearable sensors and motion capture

Outcome measures

Outcome measures
Measure	Patients Gait with and without pelvic assistance	Controls n=10 Participants Gait with no pelvic assistance
Trunk Range of Motion During Walking	—	1.34 degrees Standard Deviation 0.50

PRIMARY outcome

Timeframe: 1 day

Population: Analysis was conducted for control participants that completed the study procedure

Difference (in degrees) between hip range of motion during walking as detected by wearable sensors and motion capture

Outcome measures

Outcome measures
Measure	Patients Gait with and without pelvic assistance	Controls n=10 Participants Gait with no pelvic assistance
Hip Range of Motion During Walking	—	2.09 degrees Standard Deviation 0.90

PRIMARY outcome

Timeframe: 1 day

Population: Analysis was conducted for control participants that completed the study procedure

Difference (in degrees) between knee range of motion during walking as detected by wearable sensors and motion capture

Outcome measures

Outcome measures
Measure	Patients Gait with and without pelvic assistance	Controls n=10 Participants Gait with no pelvic assistance
Knee Range of Motion During Walking	—	3.12 degrees Standard Deviation 1.27

Adverse Events

Pelvic Assist (Patients)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Intervention (Controls)

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

Dr. Paola Contessa

Altec Inc.

Phone: 5085458236

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place