The clinical- and cost-effectiveness of functional electrical stimulation and ankle-foot orthoses for foot drop in Multiple Sclerosis: a multicentre randomized trial.

OBJECTIVE: To compare the clinical- and cost-effectiveness of ankle-foot orthoses (AFOs) and functional electrical stimulation (FES) over 12 months in people with Multiple Sclerosis with foot drop. DESIGN: Multicentre, powered, non-blinded, randomized trial. SETTING: Seven Multiple Sclerosis outpatient centres across Scotland. SUBJECTS: Eighty-five treatment-naïve people with Multiple Sclerosis with persistent (>three months) foot drop. INTERVENTIONS: Participants randomized to receive a custom-made, AFO (n = 43) or FES device (n = 42). OUTCOME MEASURES: Assessed at 0, 3, 6 and 12 months; 5-minute self-selected walk test (primary), Timed 25 Foot Walk, oxygen cost of walking, Multiple Sclerosis Impact Scale-29, Multiple Sclerosis Walking Scale-12, Modified Fatigue Impact Scale, Euroqol five-dimension five-level questionnaire, Activities-specific Balance and Confidence Scale, Psychological Impact of Assistive Devices Score, and equipment and National Health Service staff time costs of interventions. RESULTS: Groups were similar for age (AFO, 51.4 (11.2); FES, 50.4(10.4) years) and baseline walking speed (AFO, 0.62 (0.21); FES 0.73 (0.27) m/s). In all, 38% dropped out by 12 months (AFO, n = 21; FES, n = 11). Both groups walked faster at 12 months with device (P < 0.001; AFO, 0.73 (0.24); FES, 0.79 (0.24) m/s) but no difference between groups. Significantly higher Psychological Impact of Assistive Devices Scores were found for FES for Competence (P = 0.016; AFO, 0.85(1.05); FES, 1.53(1.05)), Adaptability (P = 0.001; AFO, 0.38(0.97); FES 1.53 (0.98)) and Self-Esteem (P = 0.006; AFO, 0.45 (0.67); FES 1 (0.68)). Effects were comparable for other measures. FES may offer value for money alternative to usual care. CONCLUSION: AFOs and FES have comparable effects on walking performance and patient-reported outcomes; however, high drop-outs introduces uncertainty.

Web-based physiotherapy for people affected by multiple sclerosis: a single blind, randomized controlled feasibility study.

OBJECTIVE:: To examine the feasibility of a trial to evaluate web-based physiotherapy compared to a standard home exercise programme in people with multiple sclerosis. DESIGN:: Multi-centre, randomized controlled, feasibility study. SETTING:: Three multiple sclerosis out-patient centres. PARTICIPANTS:: A total of 90 people with multiple sclerosis (Expanded Disability Status Scale 4-6.5). INTERVENTIONS:: Participants were randomized to a six-month individualized, home exercise programme delivered via web-based physiotherapy ( n = 45; intervention) or a sheet of exercises ( n = 45; active comparator). OUTCOME MEASURES:: Outcome measures (0, three, six and nine months) included adherence, two-minute walk test, 25 foot walk, Berg Balance Scale, physical activity and healthcare resource use. Interviews were undertaken with 24 participants and 3 physiotherapists. RESULTS:: Almost 25% of people approached agreed to take part. No intervention-related adverse events were recorded. Adherence was 40%-63% and 53%-71% in the intervention and comparator groups. There was no difference in the two-minute walk test between groups at baseline (Intervention-80.4(33.91)m, Comparator-70.6(31.20)m) and no change over time (at six-month Intervention-81.6(32.75)m, Comparator-74.8(36.16)m. There were no significant changes over time in other outcome measures except the EuroQol-5 Dimension at six months which decreased in the active comparator group. For a difference of 8(17.4)m in two-minute walk test between groups, 76 participants/group would be required (80% power, P > 0.05) for a future randomized controlled trial. CONCLUSION:: No changes were found in the majority of outcome measures over time. This study was acceptable and feasible by participants and physiotherapists. An adequately powered study needs 160 participants.

Accelerometer measured physical activity and sedentary time in individuals with multiple sclerosis versus age matched controls: A systematic review and meta-analysis.

BACKGROUND: People with Multiple Sclerosis (PwMS) find it more difficult to engage in physical activity (PA) than healthy controls. Accelerometers can be used to measure sedentary time and free-living physical activity, understanding the differences between PwMS and controls can help inform changes such as interventions to promote a more active lifestyle. This in turn will help prevent secondary conditions and reduce symptom progression. OBJECTIVE: To conduct a systematic review and meta-analysis on accelerometer measured sedentary behavior and physical activity between PwMS and healthy controls. METHODS: A systematic search of five databases (PubMed, Web of Science, Ovid, Science Direct and CINAHIL) from inception until 22nd November 2019. Inclusion criteria was (1) included a group of participants with a definite diagnosis of multiple sclerosis of any type; (2) have 3 or more days of PA monitoring using accelerometers during free living conditions; (3) include age matched healthy controls; (4) assess adults over the age of 18; (5) reported data had to have been reported in a manner suitable for quantitative pooling including: percent of time spent sedentary, minutes per day of sedentary, light, moderate, vigorous activity (moderate and vigorous totaled together), steps per day or counts per day. RESULTS: Initial search produced 9021 papers, after applying inclusion criteria 21 eligible papers were included in the study. One paper was a longitudinal study from which only baseline data was included. One paper was a reliability and validity study, with data for PwMS versus controls in the validity section. All other papers are cross sectional, with one being a pilot study and another a random control study. One paper used two devices in unison, only one set of data is included in the statistics. Outcome data was available for 1098 participants, 579 PwMS and 519 healthy controls. Significant differences were seen in all categories tested: (1) sedentary time (min/day), standard mean difference -0.286, P = 0.044, n = 4 studies; (2) relative sedentary time (%/day), standard mean difference -0.646, P = 0.000, n = 5 studies; (3) LPA (min/day), standard mean difference 0.337, P = 0.039, n = 5 studies; (4) relative LPA (%/day), standard mean difference 0.211, P = 0.152, n = studies; (5) MVPA (min/day), standard mean difference 0.801, P = 0.000, n = 8 studies; (6) relative MVPA (%/day), mean difference 0.914, P = 0.000, n = 5 studies; (7) step count, standard mean difference 0.894, P = 0.000, n = 8 studies; (8) activity count, standard mean difference 0.693, P = 0.000, n = 13 studies. CONCLUSION: PwMS are more sedentary and engage in less LPA, MVPA, steps per day and accelerometer counts per day than healthy controls when measured using accelerometers during free-living conditions.

Blood lactate concentrations during rest and exercise in people with Multiple Sclerosis: A systematic review and meta-analysis.

BACKGROUND: Multiple Sclerosis (MS) is a chronic disorder which irreversibly damages axons within brain matter. Blood lactate concentration could be a biomarker of MS onset and progression, but no systematic review has yet sought to confirm or dispute the elevation and biomarker potential of blood lactate in people with MS (PwMS) or to consolidate understanding of lactate production during exercise in PwMS. OBJECTIVE: To perform a systematic review and meta-analysis on blood lactate in PwMS during rest and exertion compared to Healthy Controls (HC) and following chronic exercise intervention. METHODS: A systematic search of six electronic databases (PubMed, CINAHL, Science Direct, Cochrane Library, SPORTDiscus and PEDro) was performed on 10th April 2020. Mean, standard deviation and sample size for lactate measures at rest and during exercise were pooled to determine overall effect size using a random effects model.  The 20-point Appraisal tool for Cross-Sectional Studies was utilised to assess study quality and inherent risk of bias. To qualify for inclusion, studies had to include human adults (>18 years) with a confirmed clinical diagnosis of MS, be published in English, have undergone peer review, report absolute blood lactate values for data extraction, and if involving testing during/after exercise, to do so during bilateral exercise methods. RESULTS: 18 studies were qualitatively analysed and 15 studies quantitatively analysed. Outcome data was available for 1986 participants (nMS = 1129). A total of 7 papers tested blood lactate during rest (LactateREST), 7 papers tested during sub-maximal intensity exercise (LactateSUB-MAX), and 8 papers tested during maximal intensity exercise (LactateMAX). Meta analyses showed elevated LactateREST and reduced LactateMAX in PwMS compared to HC, higher LactateMAX in lower EDSS-scoring PwMS compared to higher EDSS-scoring PwMS, and that LactateSUB-MAX decreases and LactateMAX increases in PwMS following a chronic exercise intervention. Qualitative analysis reported LactateREST to be reduced in PwMS following a chronic exercise intervention. CONCLUSIONS: LactateREST is elevated in PwMS compared to HC. LactateMAX is lower in PwMS compared to HC and lower still in higher compared to lower EDSS-scoring groups of PwMS. Chronic exercise interventions have the potential to reduce LacatateSUB-MAX for a given power output and increase LactateMAX in PwMS compared to baseline values. LactateREST may be reduced in PwMS following a chronic exercise intervention but more research is required for confirmation. The results of this review were limited by small sample sizes and number of studies available for each testing condition, limited data available for potentially confounding/correlating factors (eg. VO2 and power output) as well as heterogeneity of methodology adopted across studies, often due to lactate testing being a secondary outcome measure. PLS: Lactate levels in the blood are different during rest and at intense exercise levels in people with Multiple Sclerosis (MS) compared to healthy counterparts, with people with MS showing a smaller jump in lactate during intense exercise from a higher resting level. After exercising for at least 3 months, blood lactate levels during exercise may become more similar to the levels seen in people without Multiple Sclerosis, but more research is required to give a clearer picture of this. We can hopefully use blood lactate in future to measure the progression of MS in an individual as well as the effectiveness of their exercise programme.

Evaluating functional electrical stimulation (FES) cycling on cardiovascular, musculoskeletal and functional outcomes in adults with multiple sclerosis and mobility impairment: A systematic review.

BACKGROUND: People with Multiple Sclerosis (PwMS) are at an increased risk of diseases associated with low levels of physical activity (PA). Deconditioning may lead to an acceleration in the development of secondary complications from MS, impairing physical function and exacerbating disease progression. Functional Electrical Stimulation (FES) Cycling may provide a suitable lower limb exercise intervention for PwMS with mobility impairment. The effects of FES cycling on cardiovascular, musculoskeletal and functional outcomes for PwMS with mobility impairment are yet to be investigated to date. OBJECTIVE: The objective of this review was to systematically examine the outcomes of PwMS with mobility impairment following FES cycling intervention. METHODS: A systematic search of four electronic databases (MEDLINE, Web of Science, CINAHL and PEDro) from their inception to 8th January 2019 was performed. Inclusion criteria was (1) include human participants with definite diagnosis of MS (2) participants had to be aged 18 years or older (3) include participants with mobility impairment (determined as an average participant EDSS ≥ 6.0) (4) evaluate FES cycling as an intervention study. RESULTS: Initial searches found 1163 studies. 9 of which met the full inclusion criteria: 5 pre-post studies with no control group, 2 randomised controlled trials (RCTs), 1 retrospective study and 1 case study. Two studies had the same participant group and intervention but reported different outcomes. Outcome data was available for n = =76 unique participants, with n = =82 completing a FES cycling intervention. Of the n = =4 papers with clear dropout rates, pooled dropout rate was 25.81%. Two papers reported non-significant improvements in aerobic capacity following a FES cycling intervention. Four papers reported no change in lower limb strength and two papers reported significant reductions in spasticity post training. Four studies failed to provide information regarding adverse events with the other studies reporting n = =10 adverse events across 36 participants. CONCLUSION: Findings suggest FES cycle training may reduce CVD risk alongside trends for a reduction in spasticity post training, however the low quality of the literature precludes any definitive conclusions. FES cycle training appears to be well tolerated in PwMS with mobility impairment, with no serious adverse events.

An exploration of the experiences and utility of functional electrical stimulation for foot drop in people with multiple sclerosis.

Purpose: Functional electrical stimulation (FES) is effective in improving walking in people with multiple sclerosis (MS) with foot drop. There is limited research exploring people's experiences of using this device. This study aims to explore the utility, efficacy, acceptability, and impact on daily life of the device in people with MS.Methods: An interpretative phenomenological approach was employed. Ten participants who had used FES for 12 months were interviewed. Transcripts were analysed, and emergent themes identified.Results: Nine participants continued to use the device. Three relevant super-ordinate themes were identified; impact of functional electrical stimulation, sticking with functional electrical stimulation, and autonomy and control. Participants reported challenges using the device; however, all reported positive physical and psychological benefits. Intrinsic and external influences such as; access to professional help, the influence of others, an individual's ability to adapt, and experiences using the device, influenced their decisions to continue with the device. A thematic model of these factors was developed.Conclusions: This study has contributed to our understanding of people with MS experiences of using the device and will help inform prescribing decisions and support the continued, appropriate use of FES over the longer term.Implications for RehabilitationPeople with multiple sclerosis using functional electrical stimulation report benefits in many aspects of walking, improved psychological well-being and increased engagement in valued activities.A number of challenges impact on functional electrical stimulation use. Factors such as; a positive experience using the device, access to professional help, the influence of others, a strong sense of personal autonomy and an individual's ability to adapt, influence an individual's decision to continue using functional electrical stimulation.Clinicians prescribing functional electrical stimulation should be aware of these factors so that the right support and guidance can be provided to people with multiple sclerosis, thus improving outcomes and compliance over the long term.

Evaluating the Effect of Functional Electrical Stimulation Used for Foot Drop on Aspects of Health-Related Quality of Life in People with Multiple Sclerosis: A Systematic Review.

BACKGROUND: Multiple sclerosis (MS) is a common degenerative neurologic condition resulting in walking difficulties. Foot drop is a common walking impairment in MS that can affect health-related quality of life (HRQOL). Functional electrical stimulation (FES) can improve walking in people with MS, but its effect on HRQOL is not well established. This review investigated the effect of FES used for foot drop on HRQOL in adults with MS. METHODS: A systematic search was performed using CINAHL, MEDLINE, Cochrane Library, PubMed, and PEDro online databases. Inclusion and exclusion criteria were applied to select eligible studies. Data were extracted, and two reviewers independently rated the quality of the studies using the Effective Public Health Practice Project assessment tool. RESULTS: Eight studies were eligible for review; seven were of moderate-to-strong methodological quality and one was weak. Seven studies demonstrated significant positive effects of FES on different aspects of HRQOL as measured by the 29-item Multiple Sclerosis Impact Scale, 36-item Short Form Health Status Survey, Canadian Occupational Performance Measure, and Psychosocial Impact of Assistive Devices Scale. CONCLUSIONS: This review provides preliminary evidence that FES has a positive effect on aspects of HRQOL in people with MS; however, the variety of HRQOL outcomes used makes it difficult to determine definitive conclusions. Future larger-scale randomized studies with long-term follow-up are recommended to better understand the effect of FES on HRQOL. This will inform prescribing decisions and support compliance with FES over the longer-term.

A comparison of the initial orthotic effects of functional electrical stimulation and ankle-foot orthoses on the speed and oxygen cost of gait in multiple sclerosis.

BACKGROUND: Foot drop affects walking in people with multiple sclerosis (pwMS). This study compares the initial orthotic effects of two treatments for foot drop: ankle-foot orthoses (AFO) and functional electrical stimulation (FES), on the speed and oxygen cost of walking in MS. METHOD AND MATERIALS: Seventy-eight pwMS were randomised to receive AFO or FES (ODFS PACE (OML, Salisbury, UK)). Participants completed the 25-ft walk test (25ftWT) and 5-min self-selected walk test (5minSSWT), from which oxygen cost was determined, with and without their device. Between-, within- and sub-group analyses (based on baseline walking speed of <0.8 m/s (slow) or ≥0.8 m/s (fast)) were undertaken. RESULTS: No significant differences between baseline measures were observed. The AFO group walked significantly slower than the FES group (5minSSWT, p = 0.037, 0.11 m/s). The AFO group walked significantly slower with than without AFO (25ftWT, p = 0.037), particularly in the fast-walking group ( p = 0.011). The slow-walking FES group walked significantly faster with FES than without (25ftWT; p = 0.029, 5minSSWT; p = 0.037). There were no differences in the fast-walking FES group or in the oxygen cost for either device. CONCLUSION: AFO reduced walking speed, particularly in fast walkers. FES increased walking speed in slow, but not fast walkers.