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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53208

Enrollment

Registered

2023-05-12

Start date

2023-10-12

Completion date

Unknown

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

flaccid paresis

Interventions

Participants will undergo an AFO-stiffness optimization procedure with the ADJUST-AFO (in both study part 1 and part 2). The ADJUST-AFO is an orthotic device of which the stiffness can be altered du

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
In study 1, feasibility will be assessed as the ability to complete the ADJUST-AFO stiffness variation protocol without the necessity to stop due to pain, fatigue or discomfort measured on a 10-point numeric rating scale (NRS). For study 2, the feasibility of the ADJUST-AFO in people with calf muscle weakness will be assessed with, as primary outcomes, the ability to complete the optimization procedure (similar to study 1) and the difference in selected optimal stiffness for walking energy cost minimization compared to the usual care method. To determine the effect of AFO stiffness on daily life activities the primary outcome will be the resepctive biomechanics of the lower limb joints.	—

Measure

Time frame

In study 1, feasibility will be assessed as the ability to complete the ADJUST-AFO stiffness variation protocol without the necessity to stop due to pain, fatigue or discomfort measured on a 10-point numeric rating scale (NRS). For study 2, the feasibility of the ADJUST-AFO in people with calf muscle weakness will be assessed with, as primary outcomes, the ability to complete the optimization procedure (similar to study 1) and the difference in selected optimal stiffness for walking energy cost minimization compared to the usual care method. To determine the effect of AFO stiffness on daily life activities the primary outcome will be the resepctive biomechanics of the lower limb joints.

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Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Contacts

Public ContactN.F.J. Waterval

Amsterdam UMC

n.f.waterval@amsterdamumc.nl0205666915

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)