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Foot (Edinburgh, Scotland) Mar 2024Running, a popular recreational activity, often leads to the experience of pain and discomfort among participants impacting performance and participation longevity. The...
The effectiveness of customised 3D-printed insoles on perceived pain, comfort, and completion time among frequent Park Runners: Study protocol for a pragmatic randomised controlled trial (The ZOLES RCT).
BACKGROUND
Running, a popular recreational activity, often leads to the experience of pain and discomfort among participants impacting performance and participation longevity. The ZOLES trial evaluates customised 3D-printed insoles for reducing pain in frequent parkrunners aged 35 and over. An innovative process of foot-scanning and responses to questions relating to size, pain, discomfort, and previous medical conditions are combined leading to the production of personalised 3D-printed orthotics.
METHODS
The ZOLES trial is a pragmatic, outcome assessor blinded, randomised, controlled, superiority trial involving 200 recreational runners, randomised to receive either customised 3D-printed insoles (ZOLES) or to a "do-as-usual" control group. The study follows a robust protocol, ensuring adherence to established guidelines for clinical trials, and is based at St Mary's University, Twickenham, London. The primary outcome is change in running-related pain over a 10-week period, assessed using an 11-point Numeric Rating Scale. Secondary outcomes include overall pain and discomfort, running-related comfort, 5k-completion time, time-loss due to injuries, running exposure, and adherence to the intervention. A balanced-block randomisation process is stratified by sex and parkrun location, and an intention-to-treat analyses will be employed on all outcomes in the primary trial report. The trial includes a 52-week post-market surveillance to assess long-term effects of the customised insoles.
DISCUSSION
The ZOLES trial aims to provide insights into real-world applicability and effectiveness of customised 3D-printed insoles in reducing running-related pain and enhancing overall running experience. Despite the limitation of a subjective primary outcome measure without participant blinding, the methodological rigor, including external outcome assessment and data handling, we anticipate results that are academically credible and applicable in real-world settings The results of this trial may have important implications for runners, clinicians, and the sports footwear industry, as evidence for the use of individualised insoles to improve running experience and prevention of pain may become evident.
TRIAL REGISTRATION
The trial was pre-registered at ClinicalTrials.gov with the trial identifier NCT06034210 on September 4, 2023, and publicly posted on September 13, 2023 (https://clinicaltrials.gov/study/NCT06034210).
PROTOCOL VERSION
Version 1, September 27, 2023.
Topics: Humans; Foot; Orthotic Devices; Pain; Pain Perception; Pragmatic Clinical Trials as Topic; Printing, Three-Dimensional; Adult
PubMed: 38350194
DOI: 10.1016/j.foot.2024.102068 -
Acta Orthopaedica Feb 2024The efficacy of bracing larger curves in adolescent idiopathic scoliosis (AIS) patients is uncertain. We aimed to assess the influence of night-time bracing in AIS... (Review)
Review
BACKGROUND AND PURPOSE
The efficacy of bracing larger curves in adolescent idiopathic scoliosis (AIS) patients is uncertain. We aimed to assess the influence of night-time bracing in AIS patients with main curves exceeding 40° Cobb angle at brace initiation.
METHODS
We reviewed AIS patients treated with nighttime braces between 2005 and 2018. Patients with curves ≥ 25° and estimated growth potential were included. Patients were monitored with radiographs from brace initiation until brace weaning at skeletal maturity. Patients were grouped based on curve magnitude at initial evaluation: a control group (25-39°) and a large-curves group (≥ 40°). Progression was defined as > 5° increase.
RESULTS
We included 299 patients (control group, n = 125; large-curves group, n = 174). In the control group, 65 (52%) patients progressed compared with 101 (58%) in the large-curves group (P = 0.3). The lower-end vertebra (LEV) shifted distally post-bracing in 41 (23%) patients in the largecurves group. Patients with progressive large curves were younger (age 13.2 [SD 1.5] vs. 13.9 [SD 1.1], P = 0.009) and more premenarchal (n = 36 [42%] vs. n = 6 [9%], P < 0.001) compared with non-progressive large curves.
CONCLUSION
Progression risk in patients with curves exceeding 40° treated with night-time bracing is similar to smaller curves. The LEV moved distally in almost one-fourth of the larger curves, possibly affecting fusion levels in cases of surgery.
Topics: Humans; Adolescent; Scoliosis; Spine; Kyphosis; Radiography; Braces; Disease Progression; Retrospective Studies; Treatment Outcome
PubMed: 38347730
DOI: 10.2340/17453674.2024.39965 -
BMC Musculoskeletal Disorders Feb 2024Over the past years, the field of prosthetics and orthotics has seen incredible innovations that used to be perceived as science fiction. This editorial aims to shed...
Over the past years, the field of prosthetics and orthotics has seen incredible innovations that used to be perceived as science fiction. This editorial aims to shed light on such exciting developments, exploring how they are addressing the challenges faced by individuals with limb impairments and musculoskeletal conditions.
Topics: Humans; Artificial Limbs; Prosthesis Implantation; Orthotic Devices; Extremities
PubMed: 38347514
DOI: 10.1186/s12891-024-07246-y -
Gait & Posture Mar 2024Patellofemoral pain (PFP) is a prevalent musculoskeletal disorder associated with functional impairments. Although postural control is commonly assessed in people with... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Patellofemoral pain (PFP) is a prevalent musculoskeletal disorder associated with functional impairments. Although postural control is commonly assessed in people with PFP, there are inconsistent results regarding potential postural control deficits in this population.
RESEARCH QUESTION
This review aims to evaluate whether postural control is impaired in people with patellofemoral pain (PFP) and the effectiveness of interventions on postural control measures.
METHODS
We searched six databases from their inception to May 5, 2023. We included studies assessing clinic- or laboratory-based postural control measures in people with PFP compared to pain-free controls, and intervention studies with PFP populations. We assessed risk of bias using the Joanna Briggs Institute critical appraisal checklists and the Cochrane Risk of Bias 2 tool. We assessed the certainty of evidence using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. We used random-effects meta-analyses considering subgroups based on type of task, measure, and intervention.
RESULTS
Fifty-three studies were included. Very low certainty evidence indicated that people with PFP have shorter anterior (SMD = 0.53, 95 %CI:0.16,0.90), posteromedial (SMD = 0.54, 95 %CI:0.04,1.03) and posterolateral (SMD = 0.59, 95 %CI:0.11,1.07) reach distance, and worse composite score (SMD = 0.46, 95 %CI:0.22,0.70). Very low to moderate certainty evidence indicated that people with PFP have worse anterior-posterior and overall stability indexes during single-leg stance (SMD = -0.71, 95 %CI:-1.29,-0.14; SMD = -0.63, 95 %CI:-0.94,-0.32) and overall stability index during double-leg stance (SMD = -0.39, 95 %CI:-0.78,-0.00), but no differences in center of pressure area during stair ascent (SMD = 0.32, 95 %CI:-2.72, 3.36). Low certainty evidence indicated that kinesio taping improved anterior reach distance (SMD = -0.49, 95 %CI:-0.89,-0.09), while no significant differences were observed between pre- and post-intervention outcomes for conventional rehabilitation and rigid taping.
SIGNIFICANCE
Clinicians should use clinic- (star excursion or Y-balance tests) and laboratory-based (stability indexes) measures to identify impairments of postural control in people with PFP. Low certainty of evidence suggests short-term improvement in postural control with kinesio taping.
Topics: Humans; Patellofemoral Pain Syndrome; Evidence Gaps; Athletic Tape; Postural Balance
PubMed: 38341930
DOI: 10.1016/j.gaitpost.2024.02.002 -
Sensors (Basel, Switzerland) Feb 2024Gait event detection is essential for controlling an orthosis and assessing the patient's gait. In this study, patients wearing an electromechanical (EM) knee-ankle-foot...
Gait event detection is essential for controlling an orthosis and assessing the patient's gait. In this study, patients wearing an electromechanical (EM) knee-ankle-foot orthosis (KAFO) with a single IMU embedded in the thigh were subjected to gait event detection. The algorithm detected four essential gait events (initial contact (IC), toe off (TO), opposite initial contact (OIC), and opposite toe off (OTO)) and determined important temporal gait parameters such as stance/swing time, symmetry, and single/double limb support. These gait events were evaluated through gait experiments using four force plates on healthy adults and a hemiplegic patient who wore a one-way clutch KAFO and a pneumatic cylinder KAFO. Results showed that the smallest error in gait event detection was found at IC, and the largest error rate was observed at opposite toe off (OTO) with an error rate of -2.8 ± 1.5% in the patient group. Errors in OTO detection resulted in the largest error in determining the single limb support of the patient with an error of 5.0 ± 1.5%. The present study would be beneficial for the real-time continuous monitoring of gait events and temporal gait parameters for persons with an EM KAFO.
Topics: Adult; Humans; Ankle; Foot Orthoses; Gait; Orthotic Devices; Ankle Joint; Thigh; Biomechanical Phenomena; Walking
PubMed: 38339681
DOI: 10.3390/s24030964 -
Clinical Biomechanics (Bristol, Avon) Feb 2024Foot orthoses are therapeutic insoles designed to induce various effects on lower limb biomechanics. However, conflicting findings in previous research, highlight the...
BACKGROUND
Foot orthoses are therapeutic insoles designed to induce various effects on lower limb biomechanics. However, conflicting findings in previous research, highlight the need to better understand how foot orthoses with different features affect lower limb biomechanics during challenging tasks, particularly during unilateral drop jump landings.
METHODS
Seventeen participants with flat feet were recruited to participate in this cross-sectional descriptive study that examined the effects of thin-flexible foot orthoses and medially wedged foot orthoses on lower limb biomechanics during unilateral drop jump landings on level and valgus inclined surfaces. Midfoot, ankle, knee, and hip angles and moments were calculated and compared across conditions with repeated measures ANOVAs, using a statistical parametric mapping approach.
FINDINGS
Medially wedged and thin-flexible foot orthoses reduced ankle pronation and arch flattening during unilateral drop jump landings on level and valgus inclined surfaces. Medially wedged foot orthoses further decreased midfoot dorsiflexion and ankle eversion angles compared to thin-flexible foot orthoses. Medially wedged foot orthoses also generated greater effects on ankle kinetics and hip kinematics during unilateral drop jump landings.
INTERPRETATION
Medially wedged foot orthoses are more effective than thin-flexible foot orthoses in optimizing lower limb biomechanics during unilateral drop jump landings. While the biomechanical effects did not increase on inclined surfaces, medially wedged foot orthoses generated greater effects on proximal joints, highlighting their potential to improve hip stability and enhance overall lower limb function. Personalized foot orthoses selection based on specific biomechanical profiles should be further explored to optimize orthotic interventions benefiting individuals with musculoskeletal conditions.
Topics: Humans; Foot Orthoses; Cross-Sectional Studies; Foot; Lower Extremity; Knee Joint; Biomechanical Phenomena
PubMed: 38330734
DOI: 10.1016/j.clinbiomech.2024.106193 -
Frontiers in Bioengineering and... 2024Myoelectric pattern recognition (MPR) has evolved into a sophisticated technology widely employed in controlling myoelectric interface (MI) devices like prosthetic and... (Review)
Review
Myoelectric pattern recognition (MPR) has evolved into a sophisticated technology widely employed in controlling myoelectric interface (MI) devices like prosthetic and orthotic robots. Current MIs not only enable multi-degree-of-freedom control of prosthetic limbs but also demonstrate substantial potential in consumer electronics. However, the non-stationary random characteristics of myoelectric signals poses challenges, leading to performance degradation in practical scenarios such as electrode shifting and switching new users. Conventional MIs often necessitate meticulous calibration, imposing a significant burden on users. To address user frustration during the calibration process, researchers have focused on identifying MPR methods that alleviate this burden. This article categorizes common scenarios that incur calibration burdens as based on data distribution shift and based on dynamic data categories. Then further investigated and summarized the popular robust MPR algorithms used to reduce the user's calibration burden. We categorize these algorithms as based on data manipulate, feature manipulation and, model structure. And describes the scenarios to which each method is applicable and the conditions required for calibration. Finally, this review is concluded with the advantages of robust MPR and the remaining challenges and future opportunities.
PubMed: 38318193
DOI: 10.3389/fbioe.2024.1329209 -
Journal of Multidisciplinary Healthcare 2024To investigate the effect of dynamic orthotic garments (Thera togs) on foot pressure distribution, postural control, and endurance in children with spastic diplegic CP.
PURPOSE
To investigate the effect of dynamic orthotic garments (Thera togs) on foot pressure distribution, postural control, and endurance in children with spastic diplegic CP.
PATIENTS AND METHODS
This is a single-blind randomized controlled clinical trial involving 34 (8-10 years) with spastic diplegic CP. The control group received conventional physical therapy (CPT), whereas the study group received CPT in addition to wearing TheraTogs. We recorded foot pressure distribution, trunk control measurement scale, trunk position sense, Pediatric Berg Balance Scale (PBS), and six-minute walking distance (6MWD).
RESULTS
Both groups showed improvement. The study group had significant improvement in foot pressure distribution (p-value 0.003, 0.001, <0.001 for forefoot, midfoot, and rearfoot mean pressures respectively, and 0.005, <0.001, and 0.005 for forefoot, midfoot, and rearfoot peak pressures respectively), Pediatric balance scale, The trunk control measurement scale, and Trunk position sense (p-value < 0.001) and six-minute walking distance (p-value 0.029). Our data suggest that adding TheraTogs to conventional physiotherapy improves foot pressure, postural control, and endurance in children with spastic diplegic cerebral palsy.
CONCLUSION
Both TheraTogs and conventional physical therapy corrected foot pressure distribution, trunk control, improved balance, and increased 6MWD in children with spastic diplegic CP but the improvement was more significant in TheraTogs group.
CLINICAL TRIAL REGISTRATION
NCT05271149.
PubMed: 38314010
DOI: 10.2147/JMDH.S438474 -
Journal of Hand Therapy : Official... 2024Although the use of KT has increased considerably in the clinical practice in the last years, there is limited evidence about the effects of its application in... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Although the use of KT has increased considerably in the clinical practice in the last years, there is limited evidence about the effects of its application in proprioception.
PURPOSE
The aim of this study was to determine the effect of KT on joint position sense and force sense on the wrist of healthy subjects.
METHODS
Fifty-four subjects were analyzed in a randomized, crossover, single-blind study design. To determine the force sense, the subjects had to reach 50% of their maximum grip force. Wrist joint position sense was assessed during active repositioning tests at the target angles of 30° flexion and extension of wrist. A digital dynamometer was used to determine the sense of force and a digital goniometer was used to determine the joint position sense. Subjects were evaluated with KT (I- strip on ventral aspect of forearms from origin to insertion) and placebo (an inelastic tape was applied following the same procedure as KT).
RESULTS
No significant differences have been found in the force sense, neither in the comparisons between control and interventions (p=0.286), nor between pre and post-intervention (p=0.111). For wrist joint position sense, a statistically significant effect (p< 0.05) was found at 30º of extension between the control and experimental group in favor of the control group.
CONCLUSIONS
The application of KT did not produce changes in FS and only caused a significant improvement in JPS in extension (30º). The results appear to indicate that the application of KT to improve proprioception in healthy subjects should be reconsidered.
Topics: Humans; Proprioception; Male; Single-Blind Method; Female; Athletic Tape; Adult; Wrist Joint; Cross-Over Studies; Healthy Volunteers; Range of Motion, Articular; Young Adult; Hand Strength; Middle Aged
PubMed: 38307737
DOI: 10.1016/j.jht.2023.10.010 -
BMC Musculoskeletal Disorders Jan 2024The shortcomings of plaster in water resistance, air permeability, skin comfort, fixed stability and weight of wearing are still to be solved. 3D printed cast can... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The shortcomings of plaster in water resistance, air permeability, skin comfort, fixed stability and weight of wearing are still to be solved. 3D printed cast can overcome the above shortcomings. At present, there is a relative lack of data on the clinical application of 3D printed cast, probably due to its complexity, relatively long operating time, and high price. We aimed to compare and evaluate the short-term effectiveness, safety and advantages of 3D printed wrist cast versus polymer orthosis in the treatment of Colles fracture.
METHODS
Forty patients with Colles fracture in our hospital from June to December 2022 were selected and divided into an observation group (20 patients, treated with instant 3D printed cast) and a control group (20 cases, treated with polymer orthosis). Both groups treated with manual reduction and external fixation. The visual analogue scale (VAS), immobilization effectiveness and satisfaction scores, Disability of the Arm, Shoulder and Hand (DASH) score, complications and imaging data were collected and compared before immobilization and at 2, 6 and 12 weeks after the fracture.
RESULTS
VAS at 2 weeks after the fracture was significantly lower in the observation group than in the control group ( P < 0.05). The immobilization effectiveness and satisfaction scores at 6 weeks after the fracture were significantly higher in the observation group than in the control group (all P < 0.05). The DASH scores at 2 and 6 weeks after the fracture were significantly lower in the observation group than in the control group (all P < 0.05). There wasn't rupture of the printed cast or orthosis in both groups. There were 2 cases of skin irritation in the control group, and no skin irritation occurred in the observation group. The palmar tilt angle and ulnar inclination angle at 2 weeks and 12 weeks after the fracture were significantly higher in the observation group than in the control group (all P < 0.05).
CONCLUSIONS
Both instant 3D printed cast and polymer orthosis are effective in the treatment of Colles fracture. But instant 3D printed cast is better than polymer orthosis in areas of good clinical and imaging performance, and high patient satisfaction and comfort.
Topics: Humans; Colles' Fracture; Orthotic Devices; Braces; Fracture Fixation; Printing, Three-Dimensional; Treatment Outcome; Radius Fractures; Casts, Surgical
PubMed: 38297262
DOI: 10.1186/s12891-024-07212-8