Health TrialsbyHealthPanel

Comparing Digitally and Traditionally Made Ankle Foot Orthoses

ConditionsFlaccid ParesisSpastic ParesisCerebral PalsyStrokeSpinal Cord InjurySpina BifidaTraumatic Peripheral Nerve Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorHolland Bloorview Kids Rehabilitation Hospital

About this trial

The research is being done to compare two methods of creating AFOs: 1. The traditional method, which involves manually creating a mold from a plaster cast of the client's limb. This is time-consuming and labor-intensive; and 2. The newer method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly. We want to know whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be aged 8 years or older.

Participants should have either flaccid or spastic paresis resulting from conditions such as cerebral palsy, stroke, spinal cord injury, spina bifida, or traumatic peripheral nerve injury, leading to lower limb mobility impairments.

Participants must require a custom articulating, rigid, or energy storage and return (ESR) AFO to improve physical function for one or both sides (unilateral or bilateral).

Participants must be able to ambulate independently, though the use of gait aids is permitted.

Disqualifiers

Clients for whom the primary goal of the AFO includes wound management.

Those whose AFO is not worn for ambulation.

Clients with insensate feet or a history of ulcerations.

First-time AFO users.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Part A First Wear Period: Traditional AFO(s)

    Device

    Participants are randomized to wear traditionally produced AFOs during Weeks 1 through 3.

  • Part A First Wear Period: Digital AFO(s)

    Device

    Participants are randomized to wear digitally produced AFOs during Weeks 1 through 3.

  • Part A Second Wear Period: Traditional AFO(s)

    Device

    Participants wear traditionally produced AFOs during Weeks 4 through 6.

  • Part A Second Wear Period: Digital AFO(s)

    Device

    Participants wear digitally produced AFOs during Weeks 4 through 6.

  • Part B Long-term Evaluation Period: Traditional AFO(s)

    Device

    Participants are randomized to wear traditionally produced AFO(s) during Weeks 7 through 14.

  • Part B Long-term Evaluation Period: Digital AFO(s)

    Device

    Participants are randomized to wear digitally produced AFO(s) during Weeks 7 through 14.

Treatment groups

50 Participants
are divided into 4 treatment groups
Group A: Part A: Traditional AFO(s) wear first; Part B: Traditional AFO(s) wearActive comparator 3 interventions
Group B: Part A: Digital AFO(s) wear first; Part B: Digital AFO(s) wearExperimental treatment 3 interventions
Group C: Part A: Traditional AFO(s) wear first; Part B: Digital AFO(s) wearActive comparator 3 interventions
Group D: Part A: Digital AFO(s) wear first; Part B: Traditional AFO(s) wearActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)

Evaluates patient satisfaction related to assistive technology and services rendered. This questionnaire is commonly used in assessing performance of AFOs and other orthotic devices.

Time frame
From the shape capture visit until the end of the study at week 14

Secondary outcomes

1

Orthotic Patient-Reported Outcomes - Mobility (OPRO-M)

Designed and validated to assess orthotic users' ability to perform activities related to movement, locomotion, and/or postural transitions.

Time frame
From Week 1 until Week 6 of the study
2

Orthotics Prosthetics User's Survey (OPUS)

Assesses function, satisfaction, and quality of life of individuals using orthotic or prosthetic devices. Its Lower Extremity Functional Status component will be used since it pertains specifically to the individual's functional abilities and limitations.

Time frame
From Week 1 until Week 6 of the study
3

10-metre Walk Test

Timed walk test

Time frame
From the shape capture visit until the end of the study at Week 14
4

Timed Up and Go (TUG)

Time frame
From the shape capture visit until the end of the study at Week 14

Other outcomes

Sponsors and contacts

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

Holland Bloorview Kids Rehabilitation Hospital

Lead sponsor

Source ClinicalTrials.gov
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