A randomized trial to investigate the effects of functional electrical stimulation and therapeutic exercise on walking performance for people with multiple sclerosis Meaningful change and responsiveness in common physical performance measures in older adults. The effects of dual-channel functional electrical stimulation on stance phase sagittal kinematics in patients with hemiparesis. A feasibility study to investigate the effect of functional electrical stimulation and physiotherapy exercise on the quality of gait of people with multiple sclerosis. Dual-channel functional electrical stimulation improvements in speed-based gait classifications Impact on activities of daily living using a functional electrical stimulation device to improve dropped foot in people with multiple sclerosis, measured by the Canadian Occupational Performance Measure Neuroprosthetic effect of peroneal nerve stimulation in multiple sclerosis: a preliminary study. The effect of functional electrical stimulation on the physiological cost of gait in people with multiple sclerosis The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. The Multiple Sclerosis Impact Scale (MSIS-29): a new patient-based outcome measure. Response and prediction of improvement in gait speed from functional electrical stimulation in persons with poststroke drop foot. The significant change for the Timed 25-Foot Walk in the Multiple Sclerosis Functional Composite
Background Functional electrical stimulation ( FES ) , is a means of producing a contraction in a paralyzed or weak muscle to enable function through electrical excitation of the innervating nerve . Objective This two-group r and omized trial assessed the effects of single channel common peroneal nerve stimulation on objective aspects of gait relative to exercise therapy for people with secondary progressive multiple sclerosis ( SPMS ) . Methods Forty-four people with a diagnosis of SPMS and unilateral dropped foot completed the trial . Twenty patients were r and omly allocated to a group receiving FES and the remaining 24 to a group receiving a physiotherapy home exercise program for a period of 18 weeks . Results The exercise group showed a statistically significant increase in 10 m walking speed and distance walked in 3 min , relative to the FES group who showed no significant change in walking performance without stimulation . At each stage of the trial , the FES group performed to a significantly higher level with FES than without for the same outcome measures . Conclusion Exercise may provide a greater training effect on walking speed and endurance than FES for people with SPMS . FES may provide an orthotic benefit when outcome is measured using the same parameters . More research is required to investigate the combined therapeutic effects of FES and exercise for this patient group OBJECTIVES To estimate the magnitude of small meaningful and substantial individual change in physical performance measures and evaluate their responsiveness . DESIGN Secondary data analyses using distribution- and anchor-based methods to determine meaningful change . SETTING Secondary analysis of data from an observational study and clinical trials of community-dwelling older people and subacute stroke survivors . PARTICIPANTS Older adults with mobility disabilities in a strength training trial ( n=100 ) , subacute stroke survivors in an intervention trial ( n=100 ) , and a prospect i ve cohort of community-dwelling older people ( n=492 ) . MEASUREMENTS  Gait speed , Short Physical Performance Battery ( SPPB ) , 6-minute-walk distance ( 6MWD ) , and self-reported mobility . RESULTS Most small meaningful change estimates ranged from 0.04 to 0.06 m/s for gait speed , 0.27 to 0.55 points for SPPB , and 19 to 22 m for 6MWD . Most substantial change estimates ranged from 0.08 to 0.14 m/s for gait speed , 0.99 to 1.34 points for SPPB , and 47 to 49 m for 6MWD . Based on responsiveness indices , per-group sample sizes for clinical trials ranged from 13 to 42 for substantial change and 71 to 161 for small meaningful change . CONCLUSION Best initial estimates of small meaningful change are near 0.05 m/s for gait speed , 0.5 points for SPPB , and 20 m for 6MWD and of substantial change are near 0.10 m/s for gait speed , 1.0 point for SPPB , and 50 m for 6MWD . For clinical use , substantial change in these measures and small change in gait speed and 6MWD , but not SPPB , are detectable . For research use , these measures yield feasible sample sizes for detecting meaningful change Sixteen subjects ( aged 54.2 ± 14.1 years ) with hemiparesis ( 7.9 ± 7.1 years since diagnosis ) demonstrating a foot-drop and hamstrings muscle weakness were fitted with a dual-channel functional electrical stimulation ( FES ) system activating the dorsiflexors and hamstrings muscles . Measurements of gait performance were collected after a conditioning period of 6 weeks , during which the subjects used the system throughout the day . Gait was assessed with and without the dual-channel FES system , as well as with peroneal stimulation alone . Outcomes included lower limb kinematics and the step length taken with the non-paretic leg . Results with the dual-channel FES indicate that in the subgroup of subjects who demonstrated reduced hip extension but no knee hyperextension ( n = 9 ) , hamstrings FES  increased hip extension during terminal stance without affecting the knee . Similarly , in the subgroup of subjects who demonstrated knee hyperextension but no limitation in hip extension ( n = 7 ) , FES  restrained knee hyperextension without having an impact on hip movement . Additionally , step length was increased in all subjects . The peroneal FES  had a positive effect only on the ankle . The results suggest that dual-channel FES for the dorsiflexors and hamstrings muscles may affect lower limb control beyond that which can be attributed to peroneal stimulation alone OBJECTIVE To examine the effect of Functional Electrical Stimulation ( FES ) for dropped foot and hip instability in combination with physiotherapy core stability exercises . METHODS Twenty-eight people with secondary progressive multiple sclerosis and unilateral dropped foot participated in a r and omized crossover trial . Group1 received FES for correction of dropped foot for six weeks with the addition of hip extension for a further six weeks . In weeks 12 - 18 , FES was continued with the addition of eight sessions of core stability physiotherapy with home-based exercise . FES and home-based exercise were continued until weeks 19 - 24 . Group 2 received the same physiotherapy intervention over the first 12 weeks , adding FES in the second 12 weeks . RESULTS FES improved walking speed and Rivermead Observational Gait Analysis ( ROGA ) score , whereas physiotherapy did not . Adding gluteal stimulation further improved ROGA score . Both interventions reduced falls , but adding FES to physiotherapy reduced them further . FES had greater impact on Multiple Sclerosis Impact Scale , MSIS-29 . CONCLUSION The intervention was feasible . FES for dropped foot may improve mobility and quality of life and may reduce falls . Adding gluteal stimulation further improved gait quality . Adding physiotherapy may have enhanced the effect of FES , but FES had the dominant effect Background Functional electrical stimulation ( FES ) is becoming an accepted treatment method for enhancing gait performance in patients who present with gait difficulties result ing from hemiparesis . The purpose of this study was to test whether individuals with hemiparesis who have varied gait speeds , which place them in different functional categories , benefit to the same extent from the application of FES . Methods Thirty-six subjects with chronic hemiparesis demonstrating foot-drop and deficits in knee and /or hip control were fitted with a dual-channel FES system activating the dorsiflexors and hamstring muscles . Gait was assessed during a 2-minute walk test with and without stimulation . A second assessment was conducted after 6 weeks of daily use . Analysis was performed with the subjects stratified into three functional ambulation classes according to their initial gait categories . Results The dual-channel FES improved the gait velocity of all three subgroups . No minimal gait velocity was required in order to gain benefits from FES . For example , subjects with limited household ambulation capabilities improved their gait speed by 63.3 % ( from 0.30 ± 0.09 m/sec to 0.49 ± 0.20 m/sec ; P < 0.01 ) , while subjects with functional community ambulation capabilities improved their gait speed by 25.5 % ( from 0.90 ± 0.11 m/sec to 1.13 ± 0.22 m/sec ; P < 0.01 ) . Conclusion Dual-channel FES positively affects gait velocity in patients with chronic hemiparesis , regardless of their initial gait velocity . Furthermore , gait velocity gains may be large enough to change an individual ’s ambulation status to a higher functional category Background : Dropped foot is a common problem following multiple sclerosis . Functional electrical stimulation can elicit an active muscle contraction providing dorsiflexion and eversion . Objective : To determine if the Odstock dropped foot stimulator ( ODFS ) , improved Activities of Daily Living for people with multiple sclerosis . Method : 64 people with unilateral dropped foot due to secondary progressive multiple sclerosis took part in a r and omized controlled trial . Research volunteers were assigned to a group using the ODFS or a group who received physiotherapy exercises for 18 weeks . Outcome measures were the Canadian Occupational Performance Measure ( COPM ) and a falls diary . Results : Results of 53 research volunteers are reported . Improvements in performance and satisfaction scores were greater in the ODFS group than the exercise group ; ( p < 0.05 ) . Use of the ODFS was also perceived as effective in reducing tripping and increasing walking distance . The median number of falls were 5 in the ODFS group and 18 in the exercise group ( p = 0.036 ) over the study period . Conclusion : The study shows that people with multiple sclerosis using the ODFS increased their COPM performance and satisfaction scores of their identified problems of Activities of Daily Living more than a matched group who received physiotherapy exercises . ODFS users also experienced fewer falls OBJECTIVE To determine the neuroprosthetic effect of a peroneal nerve stimulator on tasks of functional ambulation in multiple sclerosis ( MS ) . DESIGN A single point-in-time assessment of functional ambulation tasks under the conditions of no device and peroneal nerve stimulator . SETTING Outpatient academic medical center . PARTICIPANTS Participants ( N=11 ) with diagnosis of MS ( > 6mo ) , dorsiflexion weakness , and prior usage of an ankle-foot orthosis . INTERVENTION Surface peroneal nerve stimulator for ambulation . MAIN OUTCOME MEASURES Timed 25-foot Walk portion of the MS Functional Composite ; Floor , Carpet , Up and Go , Obstacle , and Stair components of the Modified Emory Functional Ambulation Profile . RESULTS Peroneal nerve stimulator-Stair performance was significantly enhanced ( P=.05 ) versus no device , and statistical significance was approached for peroneal nerve stimulator-Obstacles ( P=.09 ) versus no device . There were no significant differences between peroneal nerve stimulator and no device conditions in the remaining outcome measures . CONCLUSIONS The neuroprosthetic effect of the peroneal nerve stimulator is modest relative to no device in the performance of specific functional tasks of ambulation in MS gait . A longitudinal , controlled trial is needed to show effectiveness Objective Functional electrical stimulation ( FES ) is used clinical ly in the management of drop foot in people suffering from neurological conditions . The aim of the study was to investigate the effects of FES , in terms of speed and physiological cost of gait , in people with multiple sclerosis ( pwMS ) . Methods Twelve pwMS and 12 healthy matched controls walked at their own preferred walking speed ( PWS ) for 5 min around a 10 m elliptical course . Subjects with MS completed the protocol with and without using their FES . In addition , control subjects completed the protocol twice more walking at the same PWS of the pwMS to which they were matched . Results Wearing FES lead to a significant improvement in walking speed ( 0.49 ms−1 and 0.43 ms−1 with and without their FES respectively ; P < 0.001 ) and a significant reduction in the physiological cost of gait ( 0.41 mL min−1 kg−1 m−1 and 0.46 mL min−1 kg−1 m−1 with and without FES respectively ; P = 0.017 ) in pwMS . The speed of walking , oxygen uptake , and physiological cost were significantly different between pwMS and controls both at preferred and matched speeds . Although pwMS exhibit a higher physiological cost of walking  , FES offers an orthotic benefit to pwMS and should be considered as a possible treatment option 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 Changes in health policy have underlined the importance of evidence -based clinical practice and rigorous evaluation of patient-based outcomes . As patient-based outcome measurement is particularly important in treatment trials of multiple sclerosis , a number of disease-specific instruments have been developed recently . One limitation of these instruments is that none was developed using the st and ard psychometric approach of reducing a large item pool generated from people with multiple sclerosis . Consequently , an outcome measure for clinical trials of multiple sclerosis that is disease specific and combines patient perspective with rigorous psychometric methods will complement existing instruments . The aim of this study was to develop such a measure . St and ard psychometric methods were used . A pool of 129 question naire items was generated from interviews with 30 people with multiple sclerosis , expert opinion and literature review . The question naire was administered by postal survey to 1530 people selected r and omly from the Multiple Sclerosis Society membership data base . Redundant items and those with limited measurement properties were removed . The remaining items ( n = 41 ) were grouped into scales using factor analysis , and then refined to form the Multiple Sclerosis Impact Scale ( MSIS-29 ) , an instrument measuring the physical ( 20 items ) and psychological ( nine items ) impact of multiple sclerosis . Five psychometric properties of the MSIS-29  ( data quality , scaling assumptions , acceptability , reliability and validity ) were examined in a separate postal survey of 1250 Multiple Sclerosis Society members . A preliminary responsiveness study of the MSIS-29 was undertaken in 55 people admitted for rehabilitation and intravenous steroid treatment of relapses . The MSIS-29 satisfied all psychometric criteria . Data quality was excellent , missing data were low ( maximum 3.9 % ) , item test-re-test reliability was high ( r = 0.65 - 0.90 ) and scale scores could be generated for > 98 % of respondents . Item descriptive statistics , item convergent and discriminant validity , and factor analysis indicated that it was legitimate to generate scores for MSIS-29 scales by summing items . MSIS-29 scales showed good variability , small floor and ceiling effects , high internal consistency ( Cronbach 's alpha < or=0.91 ) and high test-re-test reliability ( intraclass correlation < or=0.87 ) . Correlations with other measures and the analysis of group differences provided evidence that the MSIS-29 measures the physical and psychological impact of multiple sclerosis . Effect sizes ( physical scale = 0.82 , psychological scale = 0.66 ) demonstrated preliminary evidence of good responsiveness . These results indicate the MSIS-29 is a clinical ly useful and scientifically sound patient-based outcome measure of the impact of multiple sclerosis suitable for clinical trials and epidemiological studies OBJECTIVE To describe changes in and predictors of comfortable gait speed ( GS-C ) after using a foot-drop stimulator ( FDS ; Bioness L300 ; Bioness Inc , Valencia , CA ) for 42 weeks in persons who had sustained a stroke . DESIGN Secondary analysis of prospect i ve assessment s. SETTING Multicenter clinical trial . PARTICIPANTS A total of 99 subjects who had sustained a stroke ≥ 3 months earlier and who had GS-C ≤ 0.8 m/s and drop foot with a mean age of 60.7 years and a poststroke time of 4.8 years . METHODS GS-C was assessed at baseline and at 30 weeks with and without use of an FDS ( therapeutic effect ) and at 6 , 12 , 30 , 36 , and 42 weeks with use of an FDS ( total effect ) . After subjects participated in 8 physical therapy sessions , an FDS was used for ambulation over the course of 42 weeks . MAIN OUTCOME MEASUREMENTS Changes in mean GS-C over time , FDS " responder " status defined as either ≥ 0.1 m/s gain in GS-C ( the minimal clinical ly important difference [ MCID ] ) or advancing by one Perry Ambulation Category ( PAC ) , and the incidence and nature of adverse events ( AEs ) . RESULTS A total of 74 ( 75 % ) and 69 ( 70 % ) of 99 subjects completed assessment s at 30 weeks and 42 weeks , respectively . Baseline GS-C was 0.42 m/s without use of an FDS and 0.49 m/s with use of an FDS . GS-C improved to 0.54 m/s at 30 weeks without use of an FDS ( effect size = 0.75 ) and 0.54 , 0.55 , 0.58 , 0.60 , and 0.61 m/s at 6 , 12 , 30 , 36 , and 42 weeks with use of an FDS , respectively ( effect size 0.84 at 42 weeks ) . Half of the subjects achieved a maximum GS-C by 12 weeks . Approximately 18 % were PAC responders and 29 % were MCID responders for 30-week therapeutic effect , and 55 % were PAC responders and 67 % were MCID responders for 42-week total effect . After logistic regression , the following factors emerged as the strongest predictors of FDS responders : younger age , faster baseline GS-C and Timed Up and Go , and balance . At 42 weeks , 60 % reported a device-related AE ; 92 % were mild and 96 % were anticipated . CONCLUSIONS When an FDS was used , GS-C improved progressively over 42 weeks , with ≥ 50 % of patients achieving a clinical ly meaningful 42-week total effect and 50 % achieving a maximum GS-C by 12 weeks . Younger patients with greater mobility levels may benefit most from use of an FDS . AEs were frequent , mild , and reversible The Timed 25-Foot Walk is under evaluation as a clinical tool to follow patients with MS . Several approaches have been taken to define a clinical ly significant change in this measurement . This study was undertaken to define the range of values expected for the Timed 25-Foot Walk and to correlate prospect ively the change in walk-time that occurs during an exacerbation of MS associated with subjective difficulty walking . Five results from this study are emphasized . ( 1 ) Patients who were minimally affected by MS frequently walked 25 feet between three and five seconds . ( 2 ) the walk-time variability , defined as the ratio of the longest to the shortest walk-time , minus 1 , times 100 % , for three consecutive trials was generally 20 % or less ; ( 3 ) if the two fastest walk-times obtained in three trials were compared , the walk-time variability was almost always 10 % or less ; ( 4 ) for clinical ly stable individuals , the walk-times of single trials separated by 12 months or less generally varied less than 20 % ; and ( 5 ) patients who complained of difficulty walking , but who did not have changes otherwise detectable by examination , generally had a prolongation of walk-time . These results suggest that an increase of more than 20 % in the  Timed 25-Foot Walk  may indicate a significant change in gait
BACKGROUND Functional electrical stimulation ( FES ) is commonly used to ameliorate gait deficits in patients with multiple sclerosis ( PwMS ) .
This review critically evaluates the literature describing the orthotic and therapeutic effects of FES on gait in PwMS .