Status:
COMPLETED
Tactile Incentiviser Improves Partial Weight Bearing After Lower-Limb Surgery
Lead Sponsor:
Università degli Studi dell'Insubria
Conditions:
Femoral Fractures
Pelvic Fractures
Eligibility:
All Genders
18-84 years
Phase:
NA
Brief Summary
Background: After lower-limb surgery, many patients are instructed to walk with only a fraction of their body weight on the operated leg (partial weight bearing). Traditional teaching methods-verbal i...
Detailed Description
Background and Rationale Partial weight-bearing (PWB) restrictions (10-30% of body weight) are routinely prescribed for 2-6 weeks following hip or knee arthroplasty, fracture fixation, and pelvic or a...
Eligibility Criteria
Inclusion
- Recent lower-limb orthopaedic surgery with a prescription of 20 % body-weight partial weight bearing: femoral-shaft fracture fixation, pelvic fracture fixation, total hip arthroplasty, hip hemi-arthroplasty, total knee arthroplasty, or trimalleolar ankle fracture fixation.
- Able to stand and walk ≥ 5 m with a walking aid on postoperative day 1.
- Sufficient cognitive capacity and language skills to follow instructions and provide written informed consent.
Exclusion
- Pre-existing gait disorder or neurological condition affecting load perception (e.g., stroke, Parkinson's disease, peripheral neuropathy, spinal cord injury).
- Surgeon-ordered non-weight-bearing restriction.
- Foot size \< EU 35 or \> EU 47, which cannot be accommodated by the insole.
- Active foot ulcer, severe peripheral vascular disease, or local infection on the operated limb.
- Clinically significant cognitive impairment (MMSE \< 24) or language barrier precluding comprehension of study procedures.
- Participation in another interventional study that could influence gait within the past 30 days.
- Any medical condition that, in the investigator's judgement, contraindicates participation (e.g., unstable cardiopulmonary status, uncontrolled pain ≥ 7/10 NRS).
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06989554
Start Date
January 1 2024
End Date
April 25 2025
Last Update
May 25 2025
Active Locations (1)
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1
University of Insubria
Varese, Varese, Italy, 21100