To investigate whether adding a rocker bar (including rounded heel, proximally placed fulcrum and stiffened sole) significantly reduces pain, the range of motion in the ankle and the ankle moments in patients with posttraumatic ankle arthritis.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary biomechanical outcome:
Range of Motion (the maximum motion in ankle joint) during stance phase.
Priamry clinical outcome:
Pain (daily average) around the ankle measured through Visual Analogue Scale
(VAS) .
Secondary outcome
Secondary biomechenical outcomes:
Joint moments of ankle and knee
Step rate/lenght and stance time
Secondary clinical outcome:
Pain (daily maximum) around the ankle measured through Visual Analogue Scale
(VAS) .
Background summary
The prevalence of posttraumatic osteoarthritis of the ankle is over 10%. This
can be treated either surgically or conservatively. Conservative treatment is
limited to pain medication, orthosis and footwear modifications. Footwear
modifications have been widely prescribed, without any extensive evidence of
efficacy7,8,9. It is assumed that by moving the fulcrum more proximally and by
adding a heel rounding, less shifting of the body weight, hence the tibia, is
required during the second rocker of the stance phase. Another consequence of
these modifications is a reduction of the peak moments and integral of the
moments on the ankle, theoretically meaning less pressure on the ankle joint
surface. The main purpose of such an intervention is to alleviate pain.
However, only limited scientific evidence is available if this purpose is met
by shoe adaptation. We therefore designed this protocol in which we will study
the effect of a shoe intervention on range of motion and ankle moments during
stance phase and the effect on pain.
Study objective
To investigate whether adding a rocker bar (including rounded heel, proximally
placed fulcrum and stiffened sole) significantly reduces pain, the range of
motion in the ankle and the ankle moments in patients with posttraumatic ankle
arthritis.
Study design
a randomized controlled crossover study.
Intervention
The intervention shoe, referred to as type B, is a standard shoe, of the brand
Dr. Comfort, but modified with a proximally placed fulcrum, sole stiffening and
a rounded heel, hereafter called together a *rocker bar*. The same shoe without
these modifications will serve as control, hereafter called type A. All
subjects, both the patients and the healthy subjects will walk on both shoe
types. They will be randomized for the order of intervention, e.g. they will
either start with intervention A or B.
Study burden and risks
The healthy volunteers will visit the clinic twice; first for screening and
measuring shoe size (this will take about 30 min) and a second time for gait
analyses (this will take about 1.5-2 hrs) while walking on 2 different types of
shoes. The patients will be followed for 6 weeks. There will be 4 visits during
this period. At the first visit, the protocol is explained and if consent is
signed, the subjects will be examined and screened. During the other 3 visits
at the hospital, a gait analysis and pain assessment will be performed. This
will take about 45-60 minutes. During the 6 weeks the subjects are requested to
keep a diary to record their pain level, by documenting their maximum and
average pain level at each day. The travel expenses (train class 2 and/or bus)
will be reimbursed for all subjects. The patients may keep one pair of shoes,
after completion of the trial.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
For the patient group:
1. Age >= 18 years
2. Fracture of tibia, fibula or talus in medical history
3. Daily ankle and/or foot pain with a VAS score at baseline > 3
4. Radiological evidence for osteoarthritis in tibial-talar joint
5. Being able to walk at least 100 meters without any support
6. Signed Informed Consent;For the healthy volunteers:
1. Age >= 18 years
2. Signed Informed Consent
Exclusion criteria
For the patient group:
1. Concomitant conditions like cardiovascular disease or neuromuscular disease or musculo-skeletal problems in other joints that intervene with walking
2. Ankle arthrodesis or arthroplasty in place
3. Other forms of osteoarthritis (e.g. primary osteoarthritis, OA secondary to rheumatoid arthritis or haemophilia)
4. Leg length difference of more than 2 cm
5. Planned activities within the research period, like holiday, that influence the normal level of avtivity
6. Limited ankle motion in rest, defined as total passive ROM (range of motion) < 10°;For the healthy volunteers:
1. Foot or ankle pain
2. Other concomitant conditions like cardiovascular disease or neuromuscular disease or musculo-skeletal problems in other joints that intervene with walking
3. Ankle fracture in Medical History
4. Limited ankle motion in rest, defined as total passive ROM (range of motion) < 10°
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42481.042.12 |