Trial Outcomes & Findings for Movement Enhancing Device for Children (NCT NCT01959581)

NCT ID: NCT01959581

Last Updated: 2017-07-06

Results Overview

Percent of the assessment time participants are able to contact objects across different locations. Change within each session with versus without the exoskeleton donned. Slope of change across time in the intervention phase relative to in the baseline phase.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 7 months
• Results posted on: 2017-07-06

Participant Flow

Participant milestones

Measure	Movement Enhancing Device Guided play while wearing a movement assisting device Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device.
Overall Study STARTED	30
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Movement Enhancing Device Guided play while wearing a movement assisting device Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device.
Overall Study Lost to Follow-up	5

Baseline Characteristics

Movement Enhancing Device for Children

Baseline characteristics by cohort

Measure	Movement Enhancing Device n=25 Participants Guided play while wearing a movement assisting device Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device.
Age, Continuous	2.37 months STANDARD_DEVIATION 1.26 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 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	3 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	6 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 months

Population: infants born with significant brain injury and toddlers with a diagnosis of arthrogryposis multiplex congenita

Percent of the assessment time participants are able to contact objects across different locations. Change within each session with versus without the exoskeleton donned. Slope of change across time in the intervention phase relative to in the baseline phase.

Outcome measures

Measure	Movement Enhancing Device n=20 Participants Guided play while wearing a movement assisting device Movement Enhancing Device: Naturalistic play activities using the hands while wearing the movement enhancing device.
Change in Time Contacting Objects	40.75 percentage of time Standard Deviation 30.06

Adverse Events

Movement Enhancing Device

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

Michele A. Lobo

University of Delaware

Phone: 302-831-8526

Email: malobo@udel.edu

Results disclosure agreements

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