NCT04003870

Brief Summary

Compare Customized arch support orthoses (CASO) and orthotic heel lift (HL) on the effect of ATL in recreational runners with pronated feet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 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

January 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

June 25, 2019

Last Update Submit

May 13, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Peak plantarflexion moment

    8-camera motion capturing system

    Day 0

  • Peak Achilles tendon load

    Piezoelectric force platform, computed using the Newton-Euler inverse-dynamics

    Day 0

Study Arms (1)

Runner

EXPERIMENTAL

Subject will undergo an assessment wearingeither the CASO or the HL. Sequence of CASO of HL will be randomly allocated.

Device: CASODevice: HL

Interventions

CASODEVICE

Customized arch support orthoses (CASO)

Runner
HLDEVICE

Orthotic Heel Lift (HL)

Runner

Eligibility Criteria

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

You may qualify if:

  • Foot Posture Index (FPI) was used as evaluating pronated foot posture. Subjects with FPI scores of 6-12 were recruited in the current study.
  • All participants should be free of Achilles tendinopathy and triceps surae injury for 6 months.
  • no previous surgery.
  • not previously attempted any foot orthoses intervention before this study.

You may not qualify if:

  • leg-length discrepancy
  • rigid forefoot varus deformity
  • gastrocnemius equinus
  • structural hallux limitus, or rigidus
  • Any musculoskeletal or neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUHK

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Lee KKW, Ling SKK, Yung PSH. Controlled trial to compare the Achilles tendon load during running in flatfeet participants using a customized arch support orthoses vs an orthotic heel lift. BMC Musculoskelet Disord. 2019 Nov 13;20(1):535. doi: 10.1186/s12891-019-2898-0.

Related Links

MeSH Terms

Conditions

FlatfootAthletic Injuries

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Orthopaedics and Traumatology

Study Record Dates

First Submitted

June 25, 2019

First Posted

July 1, 2019

Study Start

January 1, 2019

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations