Trial Outcomes & Findings for Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy (NCT NCT06262191)

NCT ID: NCT06262191

Last Updated: 2025-05-25

Results Overview

Change in integrated soleus electromyography (mV/mV) muscle activity during stance phase of walking.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 11 participants
• Primary outcome timeframe: day 1
• Results posted on: 2025-05-25

Participant Flow

Participant milestones

Measure	Study Group Participants will walk with the new AFO, their own AFOs, and no AFOs. Differential and adjustable stiffness AFO (DAS-AFO): Walking with a differential and adjustable stiffness AFO (DAS-AFO)
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Study Group n=11 Participants Participants will walk with the new AFO, their own AFOs, and no AFOs. Differential and adjustable stiffness AFO (DAS-AFO): Walking with a differential and adjustable stiffness AFO (DAS-AFO)
Age, Continuous	21.5 years STANDARD_DEVIATION 10.1 • n=11 Participants
Sex: Female, Male Female	2 Participants n=11 Participants
Sex: Female, Male Male	9 Participants n=11 Participants
Region of Enrollment United States	11 participants n=11 Participants

PRIMARY outcome

Timeframe: day 1

Change in integrated soleus electromyography (mV/mV) muscle activity during stance phase of walking.

Outcome measures

Measure	Study Group n=11 Participants Participants will walk with the new AFO, their own AFOs, and no AFOs. Differential and adjustable stiffness AFO (DAS-AFO): Walking with a differential and adjustable stiffness AFO (DAS-AFO)
Change in Muscle Activity	-0.09 percent change based on mV/mV measures Standard Deviation 0.10

PRIMARY outcome

Timeframe: day 1

Change in metabolic cost of transport during walking. To calculate the metabolic cost of transport, the standing baseline metabolic rate for each participant and each trial was subtracted from their walking metabolic rate to estimate the net metabolic rate of walking. Next, we normalized the net metabolic rate of walking by each participant's body mass (m) and walking speed to calculate the metabolic cost of transport (J/kg*m), averaged over the last two minutes of each condition.

Outcome measures

Measure	Study Group n=10 Participants Participants will walk with the new AFO, their own AFOs, and no AFOs. Differential and adjustable stiffness AFO (DAS-AFO): Walking with a differential and adjustable stiffness AFO (DAS-AFO)
Change in Metabolic Cost of Transport	0.57 J/kg*m Standard Deviation 1.16

PRIMARY outcome

Timeframe: 1 day during walking

Change in peak ankle power during stance phase measured in w/kg. Ankle kinematics and kinetics were calculated in OpenSim using the collected three-dimensional motion capture and the ground reaction forces. The joint kinematics and ground reaction forces were filtered using a low pass fourth order recursive Butterworth filter with a cut-off frequency of 6 Hz before being used to calculate joint kinetics. The ground reaction forces were collected using two force places associated with the instrumented treadmill (Bertec Corp, Columbus, USA) collected at 1200 Hz. The resultant joint kinetics were then further filtered using the same filtering parameters. Ankle joint power was calculated as the product of the joint moment and joint angular velocity.

Outcome measures

Measure	Study Group n=11 Participants Participants will walk with the new AFO, their own AFOs, and no AFOs. Differential and adjustable stiffness AFO (DAS-AFO): Walking with a differential and adjustable stiffness AFO (DAS-AFO)
Change in Ankle Power	0.01 w/kg Standard Deviation 0.61

Adverse Events

Study Group

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

PI

Northern Arizona University

Phone: 928-523-1787

Email: zachary.lerner@nau.edu

Results disclosure agreements

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