human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE To test the hypothesis that a custom-fit valgus knee brace and custom-made lateral wedge foot orthotic will have greatest effects on decreasing the external knee adduction moment during gait when used concurrently . DESIGN Proof-of-concept , single test session , crossover trial . SETTING Biomechanics laboratory within a tertiary care center . PARTICIPANTS Patients ( n=16 ) with varus alignment and knee osteoarthritis ( OA ) primarily affecting the medial compartment of the tibiofemoral joint ( varus gonarthrosis ) . INTERVENTIONS Custom-fit valgus knee brace and custom-made full-length lateral wedge foot orthotic . Amounts of valgus angulation and wedge height were tailored to each patient to ensure comfort . MAIN OUTCOME MEASURES The external knee adduction moment ( % body weight [BW]*height [ Ht ] ) , frontal plane lever arm ( cm ) , and ground reaction force ( N/kg ) , determined from 3-dimensional gait analysis completed under 4 r and omized conditions : ( 1 ) control ( no knee brace , no foot orthotic ) , ( 2 ) knee brace , ( 3 ) foot orthotic , and ( 4 ) knee brace and foot orthotic . RESULTS The reduction in knee adduction moment was greatest when concurrently using the knee brace and foot orthotic ( effect sizes ranged from 0.3 to 0.4 ) . The mean decrease in first peak knee adduction moment compared with control was .36 % BW*Ht ( 95 % confidence interval [ CI ] , -.66 to -.07 ) . This was accompanied by a mean decrease in frontal plane lever arm of .59 cm ( 95 % CI , -.94 to -.25 ) . CONCLUSIONS These findings suggest that using a custom-fit knee brace and custom-made foot orthotic concurrently can produce a greater overall reduction in the knee adduction moment , through combined effects in decreasing the frontal plane lever arm We examined if a subject-specific amount of lateral wedge added to a foot orthosis could alter knee mechanics to potentially reduce the progression of knee osteoarthritis in patients with medial knee osteoarthritis . Twenty individuals with medial knee osteoarthritis ( > /=2 Kellgren Lawrence grade ) were prescribed a custom laterally wedged foot orthotic device . The prescribed wedge amount was the minimal wedge amount that provided the maximum amount of pain reduction during a lateral step-down test . Following an accommodation period , all subjects returned to the laboratory for a gait analysis . Knee mechanics were collected as the subjects walked at an intentional walking speed . Walking in the laterally wedged orthotic device significantly reduced the peak adduction moment during early stance ( p < 0.01 ) compared to the nonwedged device . Similarly , the wedged orthotic device significantly reduced the knee adduction excursion from heel strike to peak adduction ( p < 0.01 ) compared to the nonwedged device . No differences in the peak adduction moment during propulsion or peak adduction during stance were observed between the orthotic conditions . A subject-specific laterally wedged orthotic device was able to reduce the peak knee adduction moment during early stance , which is thought to be associated with the progression of knee osteoarthritis . Previous studies on this device have reported issues associated with foot discomfort when using wedge amounts > 7 degrees ; however , no such issues were reported in this study . Therefore , providing a custom laterally wedged orthotic device may potentially increase compliance while still potentially reducing disease progression Objective This study aim ed to determine whether the effect of laterally wedged insoles on the adduction moment in knee osteoarthritis ( OA ) declined after one month of wear , and whether higher reported use of insoles was associated with a reduced effect on the adduction moment at one month . Methods Twenty people with medial compartment OA underwent gait analysis in their own shoes wearing i ) no insoles and ; ii ) insoles wedged laterally 5 ° in r and om order .  Testing occurred at baseline and after one month of use of the insoles . Participants recorded daily use of insoles in a log-book . Outcomes were the first and second peak external knee adduction moment and the adduction angular impulse , compared across conditions and time with repeated measures general linear models . Correlations were obtained between total insole use and change in gait parameters with used insoles at one month , and change scores were compared between high and low users of insoles using general linear models . Results There was a significant main effect for condition , whereby insoles significantly reduced the adduction moment ( all p < 0.001 ) . However there was no significant main effect for time , nor was an interaction effect evident . No significant associations were observed between total insole use and change in gait parameters with used insoles at one month , nor was there a difference in effectiveness of insoles between high and low users of the insoles at this time . Conclusion Effects of laterally wedged insoles on the adduction moment do not appear to decline after one month of continuous use , suggesting that significant wedge degradation does not occur over the short-term Background The results of conservative treatment of knee osteoarthritis ( OA ) are generally evaluated in epidemiological studies with clinical outcome measures as primary outcomes . Biomechanical evaluation of orthoses shows that there are potentially beneficial biomechanical changes to joint loading ; however , evaluation in relation to clinical outcome measures in longitudinal studies is needed . Questions / purpose sWe asked ( 1 ) is there an immediate effect on gait in patients using a laterally wedged insole or valgus knee brace ;  ( 2 ) is there a late ( 6 weeks ) effect ; and ( 3 ) is there a difference between subgroups within each group with respect to patient compliance , body mass index , and OA status ? Methods This was a secondary analysis of data from a previous r and omized controlled trial of patients with early medial knee OA . A total of 91 patients were enrolled in that trial , and 73 ( 80 % ) completed it after 6 months . Of the enrolled patients , 80 ( 88 % ) met prespecified inclusion criteria for analysis in the present study . The patients were r and omized to an insole or brace . Gait was analyzed with and without wearing the orthosis ( insole or brace ) at baseline and after 6 weeks . Measurements were taken of the knee adduction moment , ground reaction force , moment arm , walking speed , and toe-out angle . Data were analyzed with regression analyses based on an intention-to-treat principle . Results A mean reduction of 4 % ( ± 10 ) ( 95 % confidence interval [ CI ] , −0.147 to −0.03 , p = 0.003 ) of the peak knee adduction moment and 4 % ( ± 13 ) ( 95 % CI , −0.009 to −0.001 , p = 0.01 ) of the moment arm at baseline was observed in the insole group when walking with an insole was compared with walking without an insole . A mean reduction of 1 % ( ± 10 ) ( 95 % CI , −0.002 to −0.001 , p = 0.001 ) of the peak knee adduction moment and no reduction of the moment arm were measured after 6 weeks . No reduction of knee adduction moment , moment arm , or ground reaction force was seen in the brace group at baseline and after 6 weeks . Subgroup analysis showed no differences in biomechanical effect for obesity , stage of OA , and whether patients showed a clinical response to the treatment . Conclusions Laterally wedged insoles unload the medial compartment only at baseline in patients with varus alignment and by an amount that might not be clinical ly important . No biomechanical alteration was seen after 6 weeks of wearing the insole . Valgus brace therapy did not result in any biomechanical alteration . Taken together , this study does not show a clinical ly relevant biomechanical effect of insole and brace therapy in patients with varus medial knee OA.Level of Evidence Level I , therapeutic study . See Instructions for Authors for a complete description of levels of evidence OBJECTIVE To evaluate the effects of a modified shoe that incorporates both lateral wedging and a variable-stiffness sole on knee joint loading in 3 population s : individuals with symptomatic and radiographic knee osteoarthritis ( OA ) , asymptomatic overweight individuals , and asymptomatic healthy weight individuals . METHODS Ninety participants ( 30 per group ) underwent a 3-dimensional gait analysis  across 3 test conditions : modified shoes , st and ard control shoes , and barefoot . For each condition , the first peak knee adduction moment ( KAM ) and knee flexion moment ( KFM ) ( both expressed as Nm/[body weight × height]% ) as well as the KAM impulse ( expressed as Nm.s/[body weight × height]% ) were determined . RESULTS The modified shoes significantly reduced the peak KAM as compared to the control shoes in both the OA ( P = 0.002 ) and the overweight ( P = 0.03 ) groups . In the OA group , there was no significant difference in peak KAM when walking in the modified shoe as compared to walking barefoot . In the overweight and the healthy weight groups , the peak KAM when walking in the modified shoe was significantly higher than that when walking barefoot ( P < 0.001 ) . Irrespective of group , the KAM impulse was significantly reduced when walking in the modified shoe as compared to the control shoe ( P < 0.001 ) and was significantly higher during both shoe conditions as compared to walking barefoot ( P < 0.001 ) . There was no change in the KFM between walking conditions for any group . CONCLUSION The findings illustrate that a shoe incorporating both a lateral wedge and a variable-stiffness sole can significantly reduce medial knee joint load . Further research examining the effects of these shoes on pain , function , and structural changes in the joint is warranted OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity OBJECTIVE To assess immediate effects of laterally wedged insoles on walking pain , external knee adduction moment , and static alignment , and whether these immediate effects together with age , body mass index , and disease severity predict clinical outcome after 3 months of wearing insoles in medial knee osteoarthritis . METHODS Forty volunteers ( mean age 64.7 years , 16 men ) were tested in r and om order with and without a pair of 5 degrees full-length lateral wedges . Immediate changes in static alignment were measured via radiographic mechanical axis and changes in adduction moment via 3-dimensional gait analysis . After 3 months of treatment with insoles , changes in pain and physical functioning were assessed via the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and patient-perceived global change scores . RESULTS Reductions in the adduction moment occurred with insoles ( first peak mean [ 95 % confidence intervals ( 95 % CI ) ] -0.22 [ -0.28 , -0.15 ] Nm/body weight x height % ) , accompanied by a reduction in walking pain of approximately 24 % ( mean [ 95 % CI ] -1.0 [ -4.0 , 2.0 ] ) . Insoles had no mean effect on static alignment . Mean improvement in WOMAC pain ( P = 0.004 ) and physical functioning ( mean [ 95 % CI ] -6 [ -11 , -1 ] ) was observed at 3 months , with 25 ( 69 % ) and 26 ( 72 % ) of 36 individuals reporting global improvement in pain and functioning , respectively . Regression analyses demonstrated that disease severity , baseline functioning , and magnitude of immediate change in walking pain and the first peak adduction moment with insoles were predictive of clinical outcome at 3 months . CONCLUSION Lateral wedges immediately reduced knee adduction moment and walking pain but had no effect on static alignment . Although some parameters predicted clinical outcome , these explained only one-third of the variance 
    Output:
    
agent
CONCLUSION Lateral wedge insoles cause small reductions in the EKAM and KAAI during walking in people with medial knee OA .
Current evidence demonstrates that lateral wedge insoles appear ineffective at attenuating structural changes in people with medial knee OA as a whole and may be better suited to targeted use in biomechanical phenotypes associated with larger reductions in knee load
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE To test the hypothesis that a custom-fit valgus knee brace and custom-made lateral wedge foot orthotic will have greatest effects on decreasing the external knee adduction moment during gait when used concurrently . DESIGN Proof-of-concept , single test session , crossover trial . SETTING Biomechanics laboratory within a tertiary care center . PARTICIPANTS Patients ( n=16 ) with varus alignment and knee osteoarthritis ( OA ) primarily affecting the medial compartment of the tibiofemoral joint ( varus gonarthrosis ) . INTERVENTIONS Custom-fit valgus knee brace and custom-made full-length lateral wedge foot orthotic . Amounts of valgus angulation and wedge height were tailored to each patient to ensure comfort . MAIN OUTCOME MEASURES The external knee adduction moment ( % body weight [BW]*height [ Ht ] ) , frontal plane lever arm ( cm ) , and ground reaction force ( N/kg ) , determined from 3-dimensional gait analysis completed under 4 r and omized conditions : ( 1 ) control ( no knee brace , no foot orthotic ) , ( 2 ) knee brace , ( 3 ) foot orthotic , and ( 4 ) knee brace and foot orthotic . RESULTS The reduction in knee adduction moment was greatest when concurrently using the knee brace and foot orthotic ( effect sizes ranged from 0.3 to 0.4 ) . The mean decrease in first peak knee adduction moment compared with control was .36 % BW*Ht ( 95 % confidence interval [ CI ] , -.66 to -.07 ) . This was accompanied by a mean decrease in frontal plane lever arm of .59 cm ( 95 % CI , -.94 to -.25 ) . CONCLUSIONS These findings suggest that using a custom-fit knee brace and custom-made foot orthotic concurrently can produce a greater overall reduction in the knee adduction moment , through combined effects in decreasing the frontal plane lever arm We examined if a subject-specific amount of lateral wedge added to a foot orthosis could alter knee mechanics to potentially reduce the progression of knee osteoarthritis in patients with medial knee osteoarthritis . Twenty individuals with medial knee osteoarthritis ( > /=2 Kellgren Lawrence grade ) were prescribed a custom laterally wedged foot orthotic device . The prescribed wedge amount was the minimal wedge amount that provided the maximum amount of pain reduction during a lateral step-down test . Following an accommodation period , all subjects returned to the laboratory for a gait analysis . Knee mechanics were collected as the subjects walked at an intentional walking speed . Walking in the laterally wedged orthotic device significantly reduced the peak adduction moment during early stance ( p < 0.01 ) compared to the nonwedged device . Similarly , the wedged orthotic device significantly reduced the knee adduction excursion from heel strike to peak adduction ( p < 0.01 ) compared to the nonwedged device . No differences in the peak adduction moment during propulsion or peak adduction during stance were observed between the orthotic conditions . A subject-specific laterally wedged orthotic device was able to reduce the peak knee adduction moment during early stance , which is thought to be associated with the progression of knee osteoarthritis . Previous studies on this device have reported issues associated with foot discomfort when using wedge amounts > 7 degrees ; however , no such issues were reported in this study . Therefore , providing a custom laterally wedged orthotic device may potentially increase compliance while still potentially reducing disease progression Objective This study aim ed to determine whether the effect of laterally wedged insoles on the adduction moment in knee osteoarthritis ( OA ) declined after one month of wear , and whether higher reported use of insoles was associated with a reduced effect on the adduction moment at one month . Methods Twenty people with medial compartment OA underwent gait analysis in their own shoes wearing i ) no insoles and ; ii ) insoles wedged laterally 5 ° in r and om order .  Testing occurred at baseline and after one month of use of the insoles . Participants recorded daily use of insoles in a log-book . Outcomes were the first and second peak external knee adduction moment and the adduction angular impulse , compared across conditions and time with repeated measures general linear models . Correlations were obtained between total insole use and change in gait parameters with used insoles at one month , and change scores were compared between high and low users of insoles using general linear models . Results There was a significant main effect for condition , whereby insoles significantly reduced the adduction moment ( all p < 0.001 ) . However there was no significant main effect for time , nor was an interaction effect evident . No significant associations were observed between total insole use and change in gait parameters with used insoles at one month , nor was there a difference in effectiveness of insoles between high and low users of the insoles at this time . Conclusion Effects of laterally wedged insoles on the adduction moment do not appear to decline after one month of continuous use , suggesting that significant wedge degradation does not occur over the short-term Background The results of conservative treatment of knee osteoarthritis ( OA ) are generally evaluated in epidemiological studies with clinical outcome measures as primary outcomes . Biomechanical evaluation of orthoses shows that there are potentially beneficial biomechanical changes to joint loading ; however , evaluation in relation to clinical outcome measures in longitudinal studies is needed . Questions / purpose sWe asked ( 1 ) is there an immediate effect on gait in patients using a laterally wedged insole or valgus knee brace ;  ( 2 ) is there a late ( 6 weeks ) effect ; and ( 3 ) is there a difference between subgroups within each group with respect to patient compliance , body mass index , and OA status ? Methods This was a secondary analysis of data from a previous r and omized controlled trial of patients with early medial knee OA . A total of 91 patients were enrolled in that trial , and 73 ( 80 % ) completed it after 6 months . Of the enrolled patients , 80 ( 88 % ) met prespecified inclusion criteria for analysis in the present study . The patients were r and omized to an insole or brace . Gait was analyzed with and without wearing the orthosis ( insole or brace ) at baseline and after 6 weeks . Measurements were taken of the knee adduction moment , ground reaction force , moment arm , walking speed , and toe-out angle . Data were analyzed with regression analyses based on an intention-to-treat principle . Results A mean reduction of 4 % ( ± 10 ) ( 95 % confidence interval [ CI ] , −0.147 to −0.03 , p = 0.003 ) of the peak knee adduction moment and 4 % ( ± 13 ) ( 95 % CI , −0.009 to −0.001 , p = 0.01 ) of the moment arm at baseline was observed in the insole group when walking with an insole was compared with walking without an insole . A mean reduction of 1 % ( ± 10 ) ( 95 % CI , −0.002 to −0.001 , p = 0.001 ) of the peak knee adduction moment and no reduction of the moment arm were measured after 6 weeks . No reduction of knee adduction moment , moment arm , or ground reaction force was seen in the brace group at baseline and after 6 weeks . Subgroup analysis showed no differences in biomechanical effect for obesity , stage of OA , and whether patients showed a clinical response to the treatment . Conclusions Laterally wedged insoles unload the medial compartment only at baseline in patients with varus alignment and by an amount that might not be clinical ly important . No biomechanical alteration was seen after 6 weeks of wearing the insole . Valgus brace therapy did not result in any biomechanical alteration . Taken together , this study does not show a clinical ly relevant biomechanical effect of insole and brace therapy in patients with varus medial knee OA.Level of Evidence Level I , therapeutic study . See Instructions for Authors for a complete description of levels of evidence OBJECTIVE To evaluate the effects of a modified shoe that incorporates both lateral wedging and a variable-stiffness sole on knee joint loading in 3 population s : individuals with symptomatic and radiographic knee osteoarthritis ( OA ) , asymptomatic overweight individuals , and asymptomatic healthy weight individuals . METHODS Ninety participants ( 30 per group ) underwent a 3-dimensional gait analysis  across 3 test conditions : modified shoes , st and ard control shoes , and barefoot . For each condition , the first peak knee adduction moment ( KAM ) and knee flexion moment ( KFM ) ( both expressed as Nm/[body weight × height]% ) as well as the KAM impulse ( expressed as Nm.s/[body weight × height]% ) were determined . RESULTS The modified shoes significantly reduced the peak KAM as compared to the control shoes in both the OA ( P = 0.002 ) and the overweight ( P = 0.03 ) groups . In the OA group , there was no significant difference in peak KAM when walking in the modified shoe as compared to walking barefoot . In the overweight and the healthy weight groups , the peak KAM when walking in the modified shoe was significantly higher than that when walking barefoot ( P < 0.001 ) . Irrespective of group , the KAM impulse was significantly reduced when walking in the modified shoe as compared to the control shoe ( P < 0.001 ) and was significantly higher during both shoe conditions as compared to walking barefoot ( P < 0.001 ) . There was no change in the KFM between walking conditions for any group . CONCLUSION The findings illustrate that a shoe incorporating both a lateral wedge and a variable-stiffness sole can significantly reduce medial knee joint load . Further research examining the effects of these shoes on pain , function , and structural changes in the joint is warranted OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity OBJECTIVE To assess immediate effects of laterally wedged insoles on walking pain , external knee adduction moment , and static alignment , and whether these immediate effects together with age , body mass index , and disease severity predict clinical outcome after 3 months of wearing insoles in medial knee osteoarthritis . METHODS Forty volunteers ( mean age 64.7 years , 16 men ) were tested in r and om order with and without a pair of 5 degrees full-length lateral wedges . Immediate changes in static alignment were measured via radiographic mechanical axis and changes in adduction moment via 3-dimensional gait analysis . After 3 months of treatment with insoles , changes in pain and physical functioning were assessed via the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and patient-perceived global change scores . RESULTS Reductions in the adduction moment occurred with insoles ( first peak mean [ 95 % confidence intervals ( 95 % CI ) ] -0.22 [ -0.28 , -0.15 ] Nm/body weight x height % ) , accompanied by a reduction in walking pain of approximately 24 % ( mean [ 95 % CI ] -1.0 [ -4.0 , 2.0 ] ) . Insoles had no mean effect on static alignment . Mean improvement in WOMAC pain ( P = 0.004 ) and physical functioning ( mean [ 95 % CI ] -6 [ -11 , -1 ] ) was observed at 3 months , with 25 ( 69 % ) and 26 ( 72 % ) of 36 individuals reporting global improvement in pain and functioning , respectively . Regression analyses demonstrated that disease severity , baseline functioning , and magnitude of immediate change in walking pain and the first peak adduction moment with insoles were predictive of clinical outcome at 3 months . CONCLUSION Lateral wedges immediately reduced knee adduction moment and walking pain but had no effect on static alignment . Although some parameters predicted clinical outcome , these explained only one-third of the variance 
    Output:
    