NCT05163782

Brief Summary

The objective of this research is to compare the new ankle foot orthosis (AFO) with prior support developed by Turbomed, with the AFO with posterior support from Turbomed as well as two competing AFOs currently on the market. With this research, we seek to answer the following questions:

  • Is the new AFO as biomechanically efficient as the AFOs currently on the market?
  • Is the new AFO more comfortable than the AFO currently on the market?
  • Is the new AFO easier to put on and attach than the AFOs currently on the market?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
Last Updated

September 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

December 15, 2021

Last Update Submit

September 13, 2023

Conditions

Foot Drop

Outcome Measures

Primary Outcomes (5)

  • Knee flexion angle during gait

    Maximum, minimum and range of motion of the knee flexion angle during gait.

    At delivery

  • Hip flexion angle during gait

    Maximum, minimum and range of motion of the hip flexion angle during gait.

    At delivery

  • Minimum foot clearance

    Minimum foot clearance is defined as the minimum distance between the foot and the ground during swing.

    At delivery

  • Comfort of participants with orthosis

    Comfort is measured with a Likert scale from 1 (not comfortable) to 5 (very comfortable).

    At delivery

  • Easy to put on orthosis

    Easy to put on is measured with a Likert scale from 1 (very difficult) to 5 (very easy).

    At delivery

Study Arms (1)

People with foot drop

EXPERIMENTAL

People with left or right foot drop

Device: New ankle foot orthosis with anterior supportDevice: Ankle foot orthosis with anterior supportDevice: Ankle foot orthosis from competitor 1Device: Ankle foot orthosis from competitor 2

Interventions

New ankle foot orthosis with anterior supportDEVICE

New ankle foot orthosis with anterior support developed by Turbomed

People with foot drop
Ankle foot orthosis with anterior supportDEVICE

Ankle foot orthosis with anterior support from Turbomed

People with foot drop
Ankle foot orthosis from competitor 1DEVICE

Ankle foot orthosis with posterior support from competitor 1

People with foot drop
Ankle foot orthosis from competitor 2DEVICE

Ankle foot orthosis with posterior support from competitor 2

People with foot drop

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Foot drop following surgery or an accident (functional calf, without contracture and not spastic)
  • Foot drop following a Cerebral Vascular Accident (with or without spasticity, mild to moderate)
  • Ability to stand and walk alone without technical assistance
  • Ability to communicate comfort/discomfort

You may not qualify if:

  • Sore to one of the feet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TOPMED

Québec, Quebec, G1S1C1, Canada

Location

MeSH Terms

Conditions

Peroneal Neuropathies

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Edith Martin, PhD

    TOPMED

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

December 20, 2021

Study Start

July 19, 2021

Primary Completion

December 30, 2022

Study Completion

June 28, 2023

Last Updated

September 14, 2023

Record last verified: 2023-03

Locations

CA(1)