NCT05280639

Brief Summary

The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2.9 years

First QC Date

September 28, 2021

Last Update Submit

May 23, 2025

Conditions

Ankle FracturesPilon Fracture

Outcome Measures

Primary Outcomes (3)

  • Ankle Range of Motion (ROM)

    maximum plantarflexion and maximum dorsiflexion

    2 weeks after surgery

  • Ankle ROM

    maximum plantarflexion and maximum dorsiflexion

    6 weeks after surgery

  • Ankle ROM

    maximum plantarflexion and maximum dorsiflexion

    6 months after surgery

Secondary Outcomes (8)

  • Self reported subject compliance with exercise program: number of days completed

    2 weeks after surgery

  • Self reported subject compliance with exercise program: number of days completed

    6 weeks after surgery

  • Lower Extremity Functional Scale score

    2 weeks after surgery.

  • Lower Extremity Functional Scale score

    6 weeks after surgery.

  • Lower Extremity Functional Scale score

    6 months after surgery.

  • +3 more secondary outcomes

Study Arms (2)

Simplified block protocol

EXPERIMENTAL

subjects in this group will perform a simplified post operative rehabilitation program using a simplified wooden block protocol

Device: Wooden block

Usual care

ACTIVE COMPARATOR

Subjects in this group will perform formal physical therapy or a home exercise program consistent with AAOS standards.

Other: Formal physical therapy or Home Exercise Program

Interventions

Wooden blockDEVICE

Individuals randomized to this group will be given a wooden block at no cost to them and a simplified version of home, self-guided exercises with instructions on how to do the exercises and how often to do so.

Simplified block protocol
Formal physical therapy or Home Exercise ProgramOTHER

Individuals randomized to this group will receive the standard formal physical therapy which are sessions run by a physical therapist, usually 2-3 times a week to rehabilitate their ankle OR follow a standardized home exercise program which will be done by yourself with exercise outlined with how they should be performed and how often

Usual care

Eligibility Criteria

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

You may qualify if:

  • Ages 18-65
  • Surgically treated open or closed fractures of the ankle or tibial plafond

You may not qualify if:

  • Contralateral lower extremity injuries that would limit weight bearing after 6 weeks
  • Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)
  • Neurological deficits that would impede ability to stand safely unassisted for home exercise regiment
  • Desire to participate in formal physical therapy program
  • Additional injury that would compromise subjects ability to follow either Home Exercise Program
  • Non ambulatory prior to injury
  • Previous ankle or tibial plafond injury on ipsilateral extremity
  • BMI \> 50
  • Severe problems maintaining follow up
  • Previous ankle/tibial plafond fracture
  • Prisoners
  • Neurological impairments that impair balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Seth Yarboro, MD

    University of Virginia Orthopaedic Surgey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric McVey, MEd

CONTACT

434.243.5382edm9u@hscmail.mcc.virginia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 28, 2021

First Posted

March 15, 2022

Study Start

October 3, 2022

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)