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Early weight bearing after ankle fracture fixation rapid returns of driving: a randomized controlled trial

Early weight bearing after ankle fracture fixation rapid returns of driving: a randomized controlled trial

Status
Unknown
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220221004
Enrollment
58
Registered
2022-02-21
Start date
2019-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

What is the best post-operative protocol for ankle fracture? This question still has no clear consensus, especially in terms of driving safety. To evaluate driving safe, we used a well-known parameter called brake response time. Ankle fracture, Brake response time, FAAM score

Interventions

Brake response time will be measured by standardized machine both non weight-bearing group and weight bearing group. All recruited patients will be assessed at three time points at 6 weeks, 12 weeks a
Active Comparator Device,Active Comparator Device
Brake response time in early weight bearing group,Brake response time in Conventional rehabilitation protocol group

Sponsors

Faculty of medicine Siriraj hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patient who underwent right sided ankle fracture fixation classified as Lauge Hansen SER-II and SER-IV at the Department of Orthopedic Surgery Siriraj Hospital, aged between 18-65 years old and was a driver who have a driver license

Exclusion criteria

Exclusion criteria: associated other right lower extremity injuries, unable to pass the ability test that included Snellen chart for visual acuity, Trails making tests for cognitive ability and 3-D block construction for perceptual ability testing, lower than IV of the Ankle of plantar flexion muscle strength grading by Oxford scale and Unstable fixation

Design outcomes

Primary

MeasureTime frame
Brake response time at 12 months after end of operation mean seconds

Secondary

MeasureTime frame
ankle range of motion at 12 months after end of operation mean degree,FAAM score at 12 months after end of operation points

Countries

Thailand

Contacts

Public ContactTHEERAWOOT THARMVIBOONSRI

Faculty of medicine Siriraj hospital, Mahidol university

th.woot@gmail.com6624197968

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026