Supports for Ankle Fractures in Early Rehabilitation (SAFER)

The effects of different types of ankle support introduced 6 weeks after surgical internal fixation for ankle fracture on gait and pain: a randomized, cross-over study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN84536917

Enrollment

Registered

2015-05-08

Start date

2012-07-10

Completion date

Unknown

Last updated

2017-09-04

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

Conditions

Internal fixation surgery for an isolated ankle fracture Surgery

Interventions

All participants will be measured in the three different supports: 1. The standard intervention was Tubigrip® (M?lnycke Health Care, Sweden), which is an elasticated compressive tubular bandage 2. Ank

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Two interrelated gait primary outcomes were: 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 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

Measure	Time frame
1. Step width (cm) 2. Walking velocity (m/s) Gait measurements were made using the GAITRite® electronic walkway (CIR Symptoms, Havertown, PA). 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) 4. Persisting and significant pain was considered an adverse event	—

Measure

Time frame

1. Step width (cm) 2. Walking velocity (m/s) Gait measurements were made using the GAITRite® electronic walkway (CIR Symptoms, Havertown, PA). 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) 4. Persisting and significant pain was considered an adverse event

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026