Skip to content

Shoe adaptation for patients with osteoarthritis in the ankle after ankle fracture

The effect of rocker profile shoes on pain and range of motion in patients with post-traumatic ankle arthritis (PTAA), compared to standard shoes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN85568283
Enrollment
16
Registered
2015-03-25
Start date
2013-08-19
Completion date
Unknown
Last updated
2015-07-06

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

Conditions

Post-traumatic ankle arthritis Musculoskeletal Diseases

Interventions

All patients test two types of shoes: one standard shoe, and the same shoes adapted with a rocker profile (including a proximally placed rocker, heel rounding and stiffened sole), with a wash-out peri

Sponsors

University Medical Centre Groningen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Fracture of tibia, fibula or talus in medical history 3. Daily ankle and/or foot pain with a NRS 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

Exclusion criteria

Exclusion criteria: 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 activity 6. Limited ankle motion in rest, defined as total passive ROM (range of motion) < 10°

Design outcomes

Primary

MeasureTime frame
1. Primary biomechanical outcome: range of motion (sagittal) in ankle during stance phase. The ROM was calculated by adding the maximum dorsal flexion during stance phase to the maximum plantar flexion from the early stance phase 2. Primary clinical outcome: pain score, reported by patients using numeric rating scale scoring (0-10). Patients kept a diary for the whole 6 weeks (so including washout), for recording the daily average pain and the daily maximum pain

Secondary

MeasureTime frame
Secondary biomechanical outcomes: sagittal ankle moments (Nm/kg), step length (m), speed (m/s), cadence (steps/min) and stance time (s). The biomechanical parameters were measured using the VICON system. Sixteen reflective markers were placed bilaterally on anatomical landmarks according to the lower body Plug-in-Gait model of Vicon. The markers were tracked by an eight-camera motion capture system (Vicon, Oxford, UK, fs = 100 Hz) to measure the kinematics. Force data were measured by force plates (AMTI; Watertown, Massachusetts, fs = 1000 Hz). Joint kinematics and kinetics were computed using VICON Nexus software and further processed using MatLab.

Countries

Netherlands

Contacts

Public ContactIrene Jetten

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026