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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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4 September 2017 |
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Main ID: |
ISRCTN84536917 |
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Date of registration:
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08/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Supports for Ankle Fractures in Early Rehabilitation (SAFER)
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Scientific title:
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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 |
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Date of first enrolment:
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10/07/2012 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN84536917 |
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Study type:
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Interventional |
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Study design:
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Randomized three-treatment three-period cross-over trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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David
Keene |
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Address:
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Kadoorie Centre for Crtitical Care Research and Education
Level 3
John Radcliffe Hospital
OX3 9DU
Oxford
United Kingdom |
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Telephone:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Internal fixation surgery for an isolated ankle fracture
Surgery
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Intervention(s)
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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. Ankle stirrup brace (protect.Ankle air foam, Medi, Germany)
3. Removable below-knee walker boot (Jura Walker Fixed, Promedics, UK)
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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National Institute for Health Research (supported by Oxford Musculoskeletal Biomedical Research Unit)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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