Supports for Ankle Fractures in Early Rehabilitation (SAFER)

Completed

• Conditions: Surgery; Internal fixation surgery for an isolated ankle fracture

• Registration Number: ISRCTN84536917
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-08
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Adults aged 18 years or over who had undergone internal fixation surgery for an isolated ankle fracture. On the day of study assessments, at the 6-week postoperative review, the orthopedic trauma surgeon seeing the participant approved removal of any ankle immobilizing device for at least short time periods and weight bearing as tolerated.

Exclusion Criteria

1. Patients with a AO type C/supra-syndesmotic ankle fracture
2. Inability to walk outdoors unaided prior to fracture
3. Severe mental health disorder
4. Dementia
5. Neurological disorder
6. Any previous severe lower limb fracture
7. Open wounds below the knee of the injured limb
8. Acute or uncontrolled illness
9. Unable to safely walk 10 m without physical support from another person

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Two interrelated gait primary outcomes were:<br>1. Step length: the distance one part of the foot moves during a step in relation to the same part of the foot in the contralateral limb<br>2. Single support time: the duration of time in the gait cycle when a single lower limb is in contact with the ground and solely supporting body weight

Secondary Outcome Measures

Name	Time	Method
1. Step width (cm)<br>2. Walking velocity (m/s)<br>Gait measurements were made using the GAITRite® electronic walkway (CIR Symptoms, Havertown, PA).<br>3. A visual analogue (VAS) was used to quantify pain and perceived difficulty immediately after each ankle support was tested (0-100; ‘no pain’ or ‘no difficulty’ and scored as 0 at one end and ‘worst pain possible’ or ‘impossible’, scored as 100)<br>4. Persisting and significant pain was considered an adverse event