The feasibility and validity of the ADJUST-AFO to determine the optimal orthotic stiffness: a proof-of-concept study

• Conditions: flaccid paresis; neuromuscular disorder; 10029317

• Registration Number: NL-OMON53208
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

For healthy subjects:
- age >=18 years;
- no history of lower leg injuries or diseases affecting the gait pattern.

For patients:
- age >=18 years;
- presence of uni- or bilateral calf muscle weakness as determined by a manual
muscle test score <5 or unable to perform three consecutive heel-rises on 1 leg;
- estimated to be able to walk for 20 minutes with the ADJUST-AFO;
- indicated for a (new) stiffness-optimized dorsal leaf AFO.

Exclusion Criteria

For healthy subjects:
- weight >120 kg;
- wearing a Cardiac Implantable Electronic Device (CIED).
- pregnancy

For patients:
- weight >120 kg;
- wearing a Cardiac Implantable Electronic Device (CIED);
- indication for a knee-ankle-foot orthosis;
- pes equines during standing, i.e. not able to achieve a neutral ankle angle
during standing;
- pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In study 1, feasibility will be assessed as the ability to complete the<br /><br>ADJUST-AFO stiffness variation protocol without the necessity to stop due to<br /><br>pain, fatigue or discomfort measured on a 10-point numeric rating scale (NRS).<br /><br><br /><br>For study 2, the feasibility of the ADJUST-AFO in people with calf muscle<br /><br>weakness will be assessed with, as primary outcomes, the ability to complete<br /><br>the optimization procedure (similar to study 1) and the difference in selected<br /><br>optimal stiffness for walking energy cost minimization compared to the usual<br /><br>care method. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes in study 1 include occurrence of possible pressure sores or<br /><br>other adverse events (assessed by the researcher).<br /><br><br /><br>Secondary outcomes in study 2 include: occurrence of possible pressure sores or<br /><br>other adverse events (assessed by the researcher) and walking energy cost with<br /><br>the optimal stiffness (absolute value, in J/kg/m), walking speed (in m/s),<br /><br>heart rate (b/min), perceived fatigue and gait kinematics between the usual<br /><br>care method and ADJUST-AFO on a treadmill and over-ground. Additionally,<br /><br>satisfaction with and time needed for the usual care optimization procedure and<br /><br>the ADJUST-AFO procedure will be recorded.</p><br>