Custom-Made Ethyl Vinyl Acetate Insoles with Arch Support Could Improve Static Balance in Diabetic Women with Neuropathic Foot.

BACKGROUND: Individuals with diabetic neuropathy may experience plantar ulcers and postural instability. Although use of an insole with arch support has the potential to decrease the incidence of plantar ulcers, the choice of proper design and material density concerning postural stability is challenging. The objective of this pilot study was to conduct a preliminary evaluation of the immediate effects of custom-made ethyl vinyl acetate insoles with arch support and Shore A values of 30 or 50 on static balance in patients with diabetes and neuropathic foot/feet. METHODS: Ten women with diabetes participated in this study. Static balance was analyzed while in double-limb standing with eyes closed and eyes open and while standing on a dominant limb with eyes open wearing shoes only and wearing shoes and insoles with Shore A values of 30 and 50. RESULTS: With insole, the mean values of center of pressure excursions decreased significantly while standing on double limbs with eyes closed. The improvement in static balance was greater while using the insole with greater density; however, the difference was not statistically significant. CONCLUSIONS: An insole with arch support made of ethyl vinyl acetate Shore A of 30 and 50, which could decrease plantar pressure concentration, had no negative effect on the static balance of diabetes. Therefore, further research on the long-term effects of such insoles on the static balance of diabetes is suggested.

The effects of a custom foot orthosis on dynamic plantar pressure in patients with chronic plantar fasciitis: A randomized controlled trial.

BACKGROUND: Plantar fasciitis is one of the most common causes of heel pain. The plantar fascia supports the longitudinal arch and absorbs ground reaction forces during the static and dynamic phase(s) of weight-bearing. The purpose of this randomized controlled trial study was to determine the effects of CAD/CAM foot orthoses that were designed based on the dynamic plantar pressure in patients with plantar fasciitis. METHODS: This study was performed on 34 patients with plantar fasciitis. Outcomes were compared based on plantar fascia thickness; peak pressure, mean pressure, and maximum force; and pain, activity of daily living, quality of life, and sports activity that were evaluated by ultrasound, plantar pressure platform, and the Foot and Ankle Outcome Score, respectively. The patients were randomly assigned into two groups: the experimental group (CAD/CAM orthoses and night splint) and the control group (night splint only). All data were recorded again after 4 weeks. RESULTS: Pain ( P = 0.002) and plantar fascia thickness ( P = 0.001) decreased significantly after 1 month of intervention. Activity of daily living ( P = 0.044) and quality of life ( P = 0.001) showed a significant increase. There was a trend in increasing peak pressure in all masking regions in both groups. The maximum force remarkably reduced in the experimental group in all regions. CONCLUSIONS: The results demonstrated that CAD/CAM foot orthoses designed based on dynamic plantar pressure with night splint can reduce the plantar fascia thickness and pain associated with plantar fasciitis and increase the activity of daily living, quality of life, and sports activity.

The influence of new medial linkage orthosis on walking and independence in spinal cord injury patients: a pilot study.

In an effort to overcome the disadvantages of reciprocating gait orthoses (RGOs) and medial linkage orthoses (MLOs), a new design of MLO was developed. Therefore the aim of this study was comparison effect of a new reciprocating MLO and traditional isocentric RGO on gait parameters and functional independence (orthosis donning and doffing time) in spinal cord injury (SCI) subjects to provide more evidence of its efficacy. Four people with motor incomplete SCI participated in this study. Each participant was fitted with an MLO and isocentric reciprocating gait orthosis (IRGO) to enable a comparison of walking speed, cadence and endurance to be performed. There were no statistically significant differences demonstrated in temporal-spatial parameters between the orthotic walking conditions in this study, but walking with the MLO improved the stride length and speed of walking by 28.57 and 40.9% compared with walking with an IRGO as a control condition. Hip flexion occurred predominantly during single-support phases, with negligible motion during double-support phases. The first and second Subjects had hip kinematic pattern more near normal when they walked with medial linkage reciprocal gait orthosis (MLRGO) in comparison with IRGO. There was significant difference between donning and doffing in two conditions (P=0.046) but there was not significant difference between two conditions in standing and sitting although these two conditions improved by new MLO. The new MLO provided a quicker and more independent gait compared with IRGO, in addition the new MLO made it easier for subjects to get from sitting to standing and from standing to sitting.

The Persian version of satisfaction assessment module of Orthotics and Prosthetics Users' Survey.

BACKGROUND: Orthotics and Prosthetics User's Survey (OPUS) was developed to measure patient satisfaction in Prosthetic and Orthotic (P&O) field. OBJECTIVE: To translate the satisfaction assessment module of OPUS (OPUS-SM) into Persian language (Persian OPUS-SM) and investigate its psychometric properties. METHODS: For cross-cultural adaptation of the OPUS-SM, the guideline suggested by the World Health Organization was recruited. A sample of 116 Persian-speaking people who received P&O devices and services, participated in this study. During the first session, participants filled out the Persian OPUS-SM and the Visual Analog Scale (VAS) regarding their satisfaction from delivered devices and services. Drawing from the above sample of 116 participants, 41 participants retook the Persian OPUS-SM 5-7 days after their first time. The results of the first and second administration sessions were analyzed to assess internal consistency, test-retest reliability, item-subscale correlation, minimal detectable change, floor and ceiling effects, criterion validity, and dimensionality of the Persian OPUS-SM. RESULTS: The Cronbach's alphas of the Persian OPUS-SM were 0.71 and 0.89 for device and service satisfaction subscales, respectively. The intraclass correlation coefficients were 0.76 and 0.90 for device and service satisfaction subscales, respectively. The SEM and MDC for device satisfaction were 6.21 and ±17.21, respectively. The SEM and MDC for service satisfaction were 2.25 and ±6.22, respectively. There was a strong correlation between VAS and satisfaction subscales of the Persian OPUS-SM. Dimensionality assessment revealed that Persian OPUS-SM is a unidimensional measure. CONCLUSIONS: The adapted and translated Persian OPUS-SM is a reliable and validated measure.

The influence of thermoplastic thoraco lumbo sacral orthoses on standing balance in subjects with idiopathic scoliosis.

BACKGROUND: Idiopathic scoliosis patients have postural equilibrium problems. OBJECTIVE: The objective of this study was to assess postural control in subjects with idiopathic scoliosis following a 4-month intervention in an unbraced position. STUDY DESIGN: Quasi-experimental. METHODS: Eight healthy girls and eight girls with idiopathic scoliosis took part. A Kistler force platform was used with a frequency of 100 Hz for recording data. The center of pressure was recorded in different positions out of brace for scoliosis and healthy subjects. Test conditions were single limb and double limb stance, with eyes open and closed, and foam and rigid surfaces. RESULTS: The data reflected a weak balance of idiopathic scoliosis subjects compared to healthy subjects. After 1 and 4 months of wearing the brace, center of pressure and center of gravity sway increased in the majority of the tests, although there were no significant differences in any of the test conditions (p > 0.05). While the center of pressure sway in medio-lateral direction decreased after 4 months of wearing a brace, in other variables center of pressure and center of gravity sway increased. CONCLUSION: Idiopathic scoliosis patients have weak balance in comparison to healthy subjects. In addition, following a period of 4 months of wearing a brace, balance parameters in the scoliosis subjects did not improve. The results show that we need more follow-up of orthoses wearing in idiopathic scoliosis subjects and suggest more studies at least 1-year follow-up to identify the efficiency of brace wear on balance. CLINICAL RELEVANCE: Scoliosis can alter postural stability and balance performance during quiet standing. Spinal deformity can alter a subject's ability to compensate for postural changes and cause gait deviations. This study investigated balance differences between the healthy and idiopathic scoliosis patients and the results of thoraco lumbo sacral orthosis brace wear. It might provide some new insight into the conservative treatment of idiopathic scoliosis patients for clinicians and researchers.

Gait evaluation of new powered knee-ankle-foot orthosis in able-bodied persons: a pilot study.

BACKGROUND: Knee-ankle-foot orthoses are utilized for walking by patients with lower limb weakness. However, they may be rejected by patients due to the lack of knee flexion available when using them for walking activities. AIM: The aim of this study was to perform a pilot study investigating the effect of a new powered knee-ankle-foot orthosis on walking in healthy persons before testing with patients with lower limb weakness. METHODS: Walking evaluation was performed on five healthy subjects (mean age: 26 ± 5.6 years). Walking trials were randomly performed in three test conditions: normal walking without an orthosis, walking with a conventional knee-ankle-foot orthosis unilaterally, and also with a new powered knee-ankle-foot orthosis applied to the same leg. RESULTS: The means of walking speed, cadence, and knee flexion during swing and step length were all decreased. Compensatory motions were increased by both orthoses compared to normal walking. More knee flexion was observed in both swing and stance phases when walking with the powered knee-ankle-foot orthosis compared to the conventional knee-ankle-foot orthosis. CONCLUSION: The results demonstrated the potential of a powered orthosis in providing improvements in gait parameters compared to a conventional device in healthy subjects but are yet untested in subjects with lower limb weakness. CLINICAL RELEVANCE: The results of this study demonstrated that a powered knee-ankle-foot orthosis could lock the knee during stance and provide active knee flexion during swing to potentially reduce the tripping during ambulation.

Comparison of custom-made and prefabricated neoprene splinting in patients with the first carpometacarpal joint osteoarthritis.

AIM: The objective of this study was to compare the effect of prefabricated and custom made thumb splints on pain, function, grip strength and key pinch In patients with basilar joint osteoarthritis. METHOD: Volunteer patients (n = 35) with first carpometacarpal joint osteoarthritis were assigned randomly to wear either a prefabricated or custom-made thumb splint or assigned to a control group. This was designed as a cross over study with two 4-week treatment periods, 2 weeks of wash out time for intervention groups between the test conditions and 10-weeks follow-up for the control group. All parameters were measured at the first visit and during the 4th, 6th and 10th weeks In the three groups. RESULTS: In the control group, paIn increased and pinch strength decreased but no statistically significant differences were found In function and grip strength. Both splints changed grip strength with no significant differences between them. PaIn was reduced with the splints, and functions and pinch strength increased significantly as compared to the baseline and control groups. In comparing the two splints only significant differences were observed In pain. CONCLUSION: In comparing two splints, paIn was the only significantly different parameter between tested parameters; with the custom-made splints demonstrating better results In paIn reduction.

Effect of powered gait orthosis on walking in individuals with paraplegia.

BACKGROUND: The important purpose of a powered gait orthosis is to provide active joint movement for patients with spinal cord injury. OBJECTIVES: The aim of this study was to clarify the effect of a powered gait orthosis on the kinematics and temporal-spatial parameters in paraplegics with spinal cord injury. STUDY DESIGN: Quasi-experimental. METHODS: Four spinal cord injury individuals experienced gait training with a powered gait orthosis for a minimum of 6 weeks prior to participating in the following walking trials: walking with an isocentric reciprocating gait orthosis and walking with both separate and synchronized movements with actuated orthotic hip and knee joints in a powered gait orthosis. Specific parameters were calculated and compared for each of the test conditions. RESULTS: Using separate and synchronized actuated movement of the hip and knee joints in the powered gait orthosis increased gait speed and step length and reduced lateral and vertical compensatory motions when compared to the isocentric reciprocating gait orthosis, but there were no significant differences in these parameters. Using the new powered gait orthosis improved knee and hip joint kinematics. CONCLUSIONS: The powered gait orthosis increased speed and step length as well as hip and knee joint kinematics and reduced the vertical and lateral compensatory motions compared to an isocentric reciprocating gait orthosis in spinal cord injury patients. CLINICAL RELEVANCE: This new powered gait orthosis has the potential to improve hip and knee joint kinematics, the temporal-spatial parameters of gait in spinal cord injury patients walking.

Comparison of the efficacy of laterally wedged insoles and bespoke unloader knee orthoses in treating medial compartment knee osteoarthritis.

BACKGROUND: Patients suffering from medial compartment knee osteoarthritis (OA) may be treated with unloader knee orthoses or laterally wedged insoles. OBJECTIVES: The aim of this study was to identify and compare the effects of them on the gait parameters and pain in these patients. STUDY DESIGN: Quasi-experimental. METHODS: Volunteer subjects with medial compartment knee OA (n = 24, mean age 59.29 ± 2.23 years) were randomly assigned to two separate groups and evaluated when wearing an unloader knee orthosis or insoles incorporating a 6° lateral wedge. Testing was performed at baseline and after six weeks of each orthosis use. A visual analog scale score was used to assess pain and gait analysis was utilized to determine gait parameters. RESULTS: Both orthoses improved all parameters compared to the baseline condition (p = 0.000). However, no significant differences in pain (p = 0.649), adduction moment (p = 0.205), speed of walking (p = 0. 056) or step length (p = 0.687) were demonstrated between them. The knee range of motion (p = 0.000) were significantly different between the two interventions. CONCLUSION: Both orthoses reduced knee pain. Maximum knee range of motion was increased by both interventions although it was 3 degrees less when wearing the knee orthosis. Clinical relevance Both orthoses reduce pain and improve gait anomalies in medial compartment knee OA. Our results suggest a laterally wedged insole can be an alternative conservative approach to unloader knee orthosis for treating symptoms of medial compartment knee OA.

The effect of an isocentric reciprocating gait orthosis incorporating an active knee mechanism on the gait of a spinal cord injury patient: a single case study.

OBJECTIVE: The aim of this study was to identify the effect of induced knee flexion during gait on the kinematics and temporal-spatial parameters during walking by a patient with spinal cord injury (SCI) through the application of an isocentric reciprocating gait orthosis (IRGO) with a powered knee mechanism. METHODS: Two orthoses were considered and evaluated for an ISCI subject with a T8 level of injury. An IRGO was initially manufactured by incorporating drop lock knee joints and was fabricated with custom molded AFOs to block ankle motion. This orthosis was also adapted with electrically-activated knee joints to provide active knee extension and flexion when disengaged. RESULTS: Walking speed, stride length and cadence were increased 37.5%, 11% and 26%, respectively with the new orthosis as compared to using the IRGO. The vertical and horizontal compensatory motions reduced compared to mechanical IRGO. At end of stance phase, knee joint flexion was 37.5° for the AKIRGO compared to 7° of movement when walking with the IRGO. The overall pattern of walking produced was comparable to that of normal human walking. CONCLUSION: Knee flexion during swing phase resulted in an improved gait performance and also reduction in compensatory motions when compared to a mechanical IRGO.