NCT06262191

Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy

Completed EARLY_PHASE1 Results posted Last updated 25 May 2025

What this trial tests

EARLY_PHASE1 trial testing Differential and adjustable stiffness AFO (DAS-AFO) in Cerebral Palsy in 11 participants. Completed in 1 June 2024.

Timeline

1 May 2024

Primary endpoint
1 June 2024

1 June 2024

Quick facts

Lead sponsor	Northern Arizona University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	1 May 2024
Primary completion	1 June 2024
Estimated completion	1 June 2024
Sites	1 location across United States

Drugs / interventions tested

• Differential and adjustable stiffness AFO (DAS-AFO)

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →

Sponsor

Northern Arizona University

Who can join

Adults 8 to 35, any sex, with Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Muscle Activity Primary · day 1

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

Group	Value	95% CI
Study Group	-0.09	± 0.10

Change in Metabolic Cost of Transport Primary · 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.

Group	Value	95% CI
Study Group	0.57	± 1.16

Change in Ankle Power Primary · 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

Group	Value	95% CI
Study Group	0.01	± 0.61

Sponsor's own description

This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.