Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Jan 8, 2025
Open Peer Review Period: Jan 8, 2025 - Jan 22, 2025
Date Accepted: Apr 2, 2025
(closed for review but you can still tweet)
Patient-reported outcome measures improve later than gait parameters obtained by instrumented insoles during recovery after tibial and malleolar fractures: prospective longitudinal observational study
ABSTRACT
Background:
According to research on the best method for monitoring recovery after musculoskeletal injury or surgery, the Patient-Reported Outcome Measurement Information System (PROMIS) and wearables such as instrumented insoles are among the most promising newer options. However, it is unknown how a patient’s health perception and improvements in instrumented insole-derived gait parameters correlate after surgery for tibial or malleolar fractures.
Objective:
The aims of this study were to compare the longitudinal trajectories in separate PROMIS (sub)scores with gait and further patient-specific parameters, as well as associations between PROMIS scores and gait parameters. It was also aimed to determine the influence of anthropometric parameters and comorbidities.
Methods:
Eighty-five patients (39 women and 46 men; average age 50.8 ± 17.1 years) requiring surgery after tibial or malleolar fractures were included in this prospective longitudinal observational study. In the hospital and during follow-up visits, the patients completed the PROMIS Global Health and Pain Interference questionnaires. During the same visits, instrumented insoles were used to assess the maximal force, pressure distribution, and angular velocity during walking. Statistical analyses were conducted using linear mixed effect models, pairwise Spearman correlation coefficients, and generalized additive models.
Results:
The gait parameters quickly improved during the first three months after surgery, followed by a slowing of further improvement. After surgery, the physical health, mental health and pain interference (PROMIS) scores increased or decreased to extrema that were reached after 6 weeks to three months, followed by a return to preinjury values. Between three and six months, no significant improvements in PROMIS scores were observed. Between six months and one year, the physical health and mental health scores improved significantly (P=.003 in both cases). Compared with women, men had better physical health and lower pain interference scores (P=.01, P=.03, respectively). Hypertension had a negative effect on the physical health score (P=.03). The associations between the PROMIS score and gait parameters were strongest at approximately three months after surgery, predominantly between the Pain Interference score and gait parameters.
Conclusions:
The patients’ perception improved later than the objective gait parameters obtained by instrumented insoles did. When the gait pattern improved, pain perception correlated with the gait parameters. Female sex and hypertension negatively influenced the PROMIS scores. Clinical Trial: German Clinical Trials Registry (DRKS00025108); https://drks.de/search/en/trial/DRKS00025108
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