Tactile Incentiviser Improves Partial Weight Bearing After Lower-Limb Surgery

NACompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

April 1, 2025

Study Completion Date

April 25, 2025

Conditions
Femoral FracturesPelvic FracturesHip Fractures (ICD-10 72.01-72.2)Hip ArthroplastyKnee ArthroplastyAnkle Fractures
Interventions
DEVICE

mechanical feedback insole

A 3-mm rubber insole containing four 15-mm spring-steel snap buttons aligned along the heel-mid-foot axis. Each insole is statically calibrated on a hydraulic press so that the buttons collapse at 20 % ± 1 % of the individual's body weight, producing an unmistakable plantar cue when the load limit is exceeded. The device is purely mechanical, requires no batteries, and is fitted on postoperative day 1. Participants wear the insole during every supervised walking session until discharge (≈ 14 days).

PROCEDURE

Standard physiotherapy without feedback device

Routine inpatient physiotherapy consisting of verbal instruction to limit loading to 20 % body weight, initial bathroom-scale training, and assisted ambulation with walker or crutches. No tactile, visual, or electronic feedback device is provided. Session frequency, walking aids, analgesia, and discharge criteria are identical to the intervention arm; duration ≈ 14 days.

Trial Locations (1)

21100

University of Insubria, Varese

All Listed Sponsors
lead

Università degli Studi dell'Insubria

OTHER

NCT06989554 - Tactile Incentiviser Improves Partial Weight Bearing After Lower-Limb Surgery | Biotech Hunter | Biotech Hunter