Health TrialsbyHealthPanel

Evaluation of a New Articulated Prosthetic Foot: Comfort, Safety and Biomechanics in Individuals With a Lower-Limb Amputation

ConditionLower-Limb Amputation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVrije Universiteit Brussel

About this trial

This clinical investigation aims to evaluate a new articulated prosthetic foot during daily-life activities.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 - 80 years

Gender: Men and Women

Unilateral / bilateral

Transtibial / transfemoral / knee disarticulation / hip disarticulation

Disqualifiers

Any neurological disease

Excessive residual limb pain and wounds

Trial design

Design model

Crossover

Treatments tested in this trial

  • New Articulated Prosthetic Foot

    Device

    Participants with a lower-limb amputation will participate in experiments with the prosthetic device

  • Current Prosthetic foot

    Device

    Participants with a lower-limb amputation will participate in experiments with the prosthetic device

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: New Articulated Prosthetic FootExperimental treatment 1 intervention
Group B: Current Prosthetic footActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Comparative Scales: Comfort, Safety, Fatigue and Pain

Visual Analog Scale (VAS) during different activities: walking on flat ground, walking on slopes, climbing and descending stairs, and walking on uneven terrain. VAS is between 0 and 100. Higher scores indicate higher comfort, safety, fatigue or pain.

Time frame
Through study completion, a period of 3 hours.
2

Preference questionnaire: 5 points Likert scale

Comparison between the current foot and the new articulated foot in several areas : Mobility \& Functionality, Comfort \& Fit, Stability \& Safety, Mechanical Performance. Likert scale is between 1 and 5, where 1 indicates "Much worse", and 5 indicates "Much better".

Time frame
Through study completion, a period of 3 hours.
3

User satisfaction questionnaire: 5 points Likert scale

Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST-device). Satisfaction scale is between 1 and 5, where 1 indicates "Not satisfied at all", and 5 indicates "Very satisfied".

Time frame
Through study completion, a period of 3 hours.

Secondary outcomes

1

Hill assessment index

Walking on slopes. Hill assessment index is between 0 and 11, where 0 indicates "Cannot do" and 11 indicates "Even steps without assistive device"

Time frame
Through study completion, a period of 3 hours.
2

Stair assessment index

Climbing and descending stairs. Index goes from 0 to 13, where 0 means "Cannot do" and 13 means "Without rail and assistive device, step over step pattern".

Time frame
Through study completion, a period of 3 hours.
3

Ankle Joint angles and angular velocities

Measured through onboard sensors (ankle encoder), in degrees and degrees/second.

Time frame
Through study completion, a period of 3 hours.
4

Temporal Gait parameters

Step time, stance and swing time, measured in seconds through on-board sensors (IMUs).

Time frame
Through study completion, a period of 3 hours.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vrije Universiteit Brussel

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: