Stretching is not essential for managing MS spasticity: A randomized controlled trial.

BACKGROUND: Clinical practice, expert opinion, and evidence-based guidelines recommend daily stretching as first-line treatment for multiple sclerosis (MS) spasticity, but this has not been evaluated by fully powered clinical trials. OBJECTIVE: To determine whether MS Spasticity: Take Control (STC), a guideline-based program of spasticity education and stretching exercises has different effects on the impact of spasticity than a control program of different spasticity education and range of motion (ROM) exercises. METHODS: Ambulatory people with self-reported MS spasticity were randomly assigned to STC or ROM, delivered in same duration, facilitator-led, group classes, face-to-face (F2F) initially and later virtually, due to coronavirus disease 2019 (COVID-19). Multiple Sclerosis Spasticity Scale (MSSS) scores were compared between groups at 1 (primary outcome) and 6 months after interventions. RESULTS: A total of 231 people enrolled. There was no significant difference in MSSS scores between STC and ROM at 1 month (mean difference = 0.28, 95% (confidence interval (CI)) = [-9.45 to 10.01], p = 0.955). There were significant group mean improvements in MSSS scores and most other outcomes at 1 and 6 months. CONCLUSION: Education with stretching exercises, the first-line recommended treatment for MS spasticity, and education with ROM exercises may both improve MS spasticity to a similar degree. This study debunks the belief that stretching is essential to managing MS spasticity.

Free From Falls education and exercise program for reducing falls in people with multiple sclerosis: A randomized controlled trial.

BACKGROUND: People with multiple sclerosis (PwMS) fall frequently. Community-delivered exercise and education reduce falls in older adults, but their efficacy in multiple sclerosis (MS) is unknown. OBJECTIVES: To evaluate the impact of the Free From Falls (FFF) group education and exercise program on falls in PwMS. METHODS: This was a prospective, assessor-blinded, two-arm parallel randomized controlled trial. Ninety-six participants were randomized to FFF (eight weekly 2 hour sessions) or the control condition (a fall prevention brochure and informing their neurologist of their fall history). Participants counted falls prospectively from enrollment through 6 months following intervention. Effects on fall frequency were evaluated by the Bayesian analysis. RESULTS: The modeled mean fall frequency pre-intervention was 1.2 falls/month in the FFF group (95% credible intervals (CIs) = 0.8-2.0) and 1.4 falls/month in the control group (95% CI = 0.9-2.1). Fall frequency decreased by 0.6 falls/month in both groups over time (nadir 4-6 months post-intervention: FFF 0.6 falls/month (95% CI = 0.4-0.9); control 0.8 falls/month (95% CI = 0.5-1.1)). CONCLUSION: In-person group exercise and education are not superior to written education and neurologist-initiated interventions for preventing falls in PwMS.

Moderators of Improvements in Fatigue Impact After a Self-management Intervention in Multiple Sclerosis: A Secondary Analysis of a Randomized Controlled Trial.

ABSTRACT: Fatigue is one of the most common and disabling symptoms of multiple sclerosis. A recent randomized controlled trial comparing a fatigue self-management program and a general multiple sclerosis education program found that both programs improved fatigue in participants with multiple sclerosis. Participants were randomized to a self-management program (fatigue: take control, n = 109) or a multiple sclerosis education program (multiple sclerosis: take control, n = 109). This secondary analysis of that trial used multilevel moderation analysis to examine moderators of treatment-related effects on fatigue (Modified Fatigue Impact Scale) from baseline through the 6-mo follow-up. The following potential treatment moderators were examined: age, sex, cohabitation/marital status, and baseline levels of self-efficacy, depression symptoms, and sleep quality. Cohabitation status (living with or without a spouse/partner) interacted with intervention group and time to predict fatigue impact (P = 0.04). Fatigue: take control participants who lived with a spouse/partner showed a marginal effect in greater rate of improvement in fatigue compared with those who lived alone (P = 0.08). However, rates of improvement in fatigue in multiple sclerosis: take control participants were similar in those living with or without a spouse/partner. These findings suggest that living with a spouse or partner may facilitate benefit from self-management interventions for multiple sclerosis-related fatigue. Future research should investigate the contribution of supportive others in self-management of fatigue in multiple sclerosis.

A multisite randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Very long term (5-6 year) follow-up at one site.

BACKGROUND: A multicomponent group MS fatigue self-management program reduced fatigue impact compared to a rigorous control 12 months after enrollment. OBJECTIVES: Assess and compare changes between groups in fatigue impact and behavior changes implemented 5-6 years after enrollment. METHODS: The Modified Fatigue Impact Scale (MFIS) and a behavior change questionnaire were administered 5-6 years after enrollment. RESULTS: There were no significant changes in mean MFIS scores within or between groups from baseline to 5-6 years later. Behavior changes were of similar frequency in both groups. CONCLUSION: Fatigue impact was stable and behavior changes were similar between groups 5-6 years after a fatigue self-management program.

MS Spasticity: Take Control (STC) for ambulatory adults: protocol for a randomized controlled trial.

BACKGROUND: Spasticity affects 60-80% of people with multiple sclerosis (MS), impacting activity, participation and quality of life. We developed the group delivered spasticity self-management program, "MS Spasticity: Take Control" (STC), with DVDs for education and lower extremity stretching. STC is based on an international guideline and recommendations from systematic reviews and emphasizes the importance of stretching with specific stretching exercises. Our pilot trial (n = 38) compared STC followed by one month of home stretching practice to unguided use of the National MS Society (NMSS) brochure titled "Stretching for People with MS: An Illustrated Manual," also followed by one month of home stretching practice. In this pilot trial, STC showed promising effects on the impact of spasticity (MS Spasticity Scale-88) and other self-report and physical performance measures. We will now carry out a fully-powered trial to evaluate the effect of STC compared to a comparably delivered control program on the impact and severity of spasticity in people with MS and self-reported lower extremity spasticity. METHODS: Two hundred-twenty ambulatory adults with MS self-reported spasticity interfering with daily activities will be randomized 1:1 to STC or control, using the same NMSS brochure used in the pilot study, with both programs delivered in groups with trained facilitators. Outcomes are the impact of spasticity with the MS Spasticity Scale-88, the severity of spasticity with the Numeric Rating Scale for Spasticity, other self-report questionnaires, and physical performance walking measures at baseline and one and 6 months after the interventions. DISCUSSION: Stretching is the cornerstone of spasticity management. Stretching takes time and energy every day. Unfortunately, beyond the logical expectation that regular stretching should help prevent muscle shortening and contractures in the presence of spasticity, there is very little data on the effects of stretching on spasticity in people with MS or any other condition. Our pilot trial of STC suggested that education and stretching help reduce the impact of spasticity. To definitively determine if this education and instructional program with daily stretching practice is effective, a fully powered trial with a comparable control intervention and facilitators who did not create STC is needed. Here we report the protocol for this trial. TRIAL REGISTRATION: NCT03166930 May 25, 2017.

Assessment and Measurement of Spasticity in MS: State of the Evidence.

PURPOSE OF REVIEW: The purpose of this review is to familiarize the reader with assessments and measurement of spasticity in people with multiple sclerosis (MS). Spasticity affects 60-84% of people with MS, worsening as disability worsens and impacting activity, participation, and quality of life. Spasticity manifests in many ways, including spasms, resistance to passive stretch, pain, and perception of tightness, and can affect muscles throughout the body, making assessment and quantification of spasticity challenging but important. Assessment tools include those quantified by clinicians, instrumentation, and patients. RECENT FINDINGS: Most tools for measuring spasticity are based on clinician scoring, were developed many years ago, and have undergone minimal recent advances. More recent developments are patient-reported outcome measures for spasticity, including the Numeric Rating Scale for Spasticity (NRS-S) and the disease-specific Multiple Sclerosis Spasticity Scale-88 (MSSS), and, most recently, imaging through elastography. MS-related spasticity is common and often disabling. There are various spasticity measurement tools available, each with advantages and limitations. Newer tools are likely to be developed as our understanding of spasticity in MS grows.

Evaluation of a web-based fall prevention program among people with multiple sclerosis.

BACKGROUND: Falls are common and impactful in people with multiple sclerosis (MS) but currently there is no accepted standard of care for fall prevention in MS. Evidence supports that the in-person, group-based, Free from Falls (FFF) program is associated with both immediate and six-month sustained improvements in mobility and balance and a reduction in falls, but program attendance is limited by access to the class at a given time and location and by the cost and availability of trained facilitators. Therefore, we developed and evaluated an online, web-based version of FFF, Free from Falls Online (FFFO). METHODS: Thirty people with MS who reported falling at least twice in the previous two months were randomized to FFFO or to a control group. FFFO consists of eight weekly sessions, each with an instructional and exercise component. Subjects in the control group were given a brochure on minimizing fall risk, a letter was sent to their treating physician informing them that the subject reported falling, and these subjects were invited to use the FFFO program at study completion. Outcomes included baseline demographics, falls prospectively reported for the eight weeks of intervention and the following three months, and a program satisfaction survey for the active group. Regression models were used to test for associations between treatment group and fall incidence. RESULTS: Subjects' mean age was 55.8 years, 70% were female, 73% had progressive MS, median Expanded Disability Status Scale (EDSS) score was 6.0, and subjects reported a median of two falls in the month prior to study enrollment. Although, in general, regression models demonstrated trends that those in the intervention group were less likely to fall than those in the control group, statistical significance was only achieved (p = 0.0038) with a post hoc model evaluating the relationship between the square of days and the probability of not falling. This model supported that those in the intervention group were slightly less likely to fall than those in the control group. This difference was most prominent in the first month of the study, less prominent in the following month, and not sustained three months following the intervention. User experience with FFFO was overall positive, with over 75% reporting the web-based program easy to learn and to use, 85% reporting the program was easy to follow, 62% reporting the material to be useful, and 77% finding the exercises to be a useful component of the program. CONCLUSION: This study supports the viability of online delivery of self-management strategies in MS, suggests that FFFO may help prevent falls in people with MS, and provides the preliminary data needed to verify the findings of this pilot study of FFFO with a fully powered randomized controlled trial in people with MS.

A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Short- and medium-term benefits.

BACKGROUND: Fatigue occurs in 75%-95% of people with multiple sclerosis (MS) and is frequently reported as the most disabling symptom. A multicomponent group program of six weekly 2-hour sessions, Fatigue: Take Control (FTC), was developed from an international MS fatigue management guideline. OBJECTIVE: To determine whether FTC is associated with greater improvements in fatigue than MS: Take Control (MSTC), a similarly structured general MS education program. METHODS: This four-site, parallel, single-blind, randomized controlled trial compared FTC and MSTC in 204 ambulatory participants with MS. The primary outcome, the Modified Fatigue Impact Scale (MFIS), and secondary outcomes of self-efficacy, physical activity, sleep, and medications were assessed at baseline, program completion, and 3 and 6 months later. RESULTS: Mean MFIS scores improved in both groups between baseline and program completion (FTC -4.4, p < 0.001; MSTC -3.8, p < 0.001), between baseline and 3 months after program completion (FTC -3.2, p = 0.01; MSTC -3.3, p = 0.01), and between baseline and 6 months after program completion (FTC -5.2, p < 0.001; MSTC -4.8, p < 0.001). These improvements were not statistically different between groups ( p = 0.64, 0.92, and 0.82, respectively). CONCLUSION: Participation in FTC modestly improved self-reported fatigue for up to 6 months. This improvement did not differ significantly from that occurring with the control program.

A multicenter randomized controlled trial of two group education programs for fatigue in multiple sclerosis: Long-term (12-month) follow-up at one site.

BACKGROUND: A four-site RCT of Fatigue: Take Control (FTC), a multicomponent group program, found no significant differences from a control program, MS: Take Control (MSTC), in fatigue on the Modified Fatigue Impact Scale (MFIS) through 6 months. OBJECTIVE: Assess FTC for a delayed effect on fatigue. METHODS: Of 78 subjects at one site, 74 randomized to FTC or MSTC completed the MFIS at 12 months. RESULTS: Compared to baseline, FTC produced greater improvements in MFIS scores than MSTC (FTC -8.9 (confidence interval (CI): 32.2, 45), MSTC -2.5 (CI 39.6, 47.7), p = 0.03) at 12 months. CONCLUSION: The delayed effect of FTC on fatigue suggests the need for longer follow-up when assessing interventions for fatigue.

ADSTEP: Preliminary Investigation of a Multicomponent Walking Aid Program in People With Multiple Sclerosis.

OBJECTIVE: To evaluate the effect of the Assistive Device Selection, Training and Education Program (ADSTEP) on falls and walking and sitting activity in people with multiple sclerosis (PwMS). DESIGN: Randomized controlled trial. SETTING: Veterans affairs medical center. PARTICIPANTS: PwMS (N=40) using a walking aid at baseline who had fallen in the previous year. INTERVENTIONS: Participants were randomly assigned to ADSTEP or control. ADSTEP had 6 weekly, 40-minute, 1-on-1 sessions with a physical therapist, starting with walking aid selection and fitting, followed by task-oriented progressive gait training. Control was usual medical care with the option of ADSTEP after the study. MAIN OUTCOME MEASURES: The following were assessed at baseline, intervention completion, and 3 months later: falls, timed Up and Go, timed 25-foot walk, 2-minute walk, Four Square Step Test, International Physical Activity Questionnaire, Quebec User Evaluation of Satisfaction with Assistive Technologies, Multiple Sclerosis Walking Scale-12, Activities-Specific Balance Confidence Scale, and Multiple Sclerosis Impact Scale-29. Effect on these outcomes was estimated by a 2-by-2 repeated measures general linear model. RESULTS: Fewer ADSTEP than control participants fell (χ2=3.96, P<.05. number needed to treat =3.3). Time spent sitting changed significantly differently with ADSTEP than with control from baseline to intervention completion (F=11.16, P=.002. ADSTEP: reduced 87.00±194.89min/d; control: increased 103.50±142.21min/d; d=0.88) and to 3-month follow-up (F=9.25, P=.004. ADSTEP: reduced 75.79±171.57min/d; control: increased 84.50±149.23min/d; d=0.79). ADSTEP yielded a moderate effect on time spent walking compared to control at 3-month follow-up (P>.05. ADSTEP 117.53±148.40min/d; control 46.43±58.55min/d; d=0.63). CONCLUSIONS: ADSTEP prevents falls, reduces sitting, and may increase walking in PwMS.

A group-delivered self-management program reduces spasticity in people with multiple sclerosis: A randomized, controlled pilot trial.

BACKGROUND: Spasticity affects more than 80% of people with multiple sclerosis (MS), affecting activity, participation, and quality of life. Based on an international guideline, an MS spasticity group education and stretching program, MS Spasticity: Take Control (STC), has been developed. OBJECTIVE: The objective of this paper is to determine whether STC with home stretching is associated with greater changes in spasticity than usual care (UC), consisting of an illustrated stretching booklet and home stretching but without group instruction or support, in people with MS. METHODS: Ambulatory MS patients with self-reported spasticity interfering with daily activities were randomized to STC or UC. Individuals completed questionnaires regarding MS, spasticity, walking, fatigue and mood, and physical measures of spasticity and walking. RESULTS: Thirty-eight of 40 participants completed both assessments. Mean total score and scores on two subscales of the MS Spasticity Scale-88 improved more with STC than with UC (p < 0.03). There was no significant change in the Modified Ashworth Scale in either group. Mean scores on the Modified Fatigue Impact Scale, the Beck Depression Inventory-II, and the physical component of the Multiple Sclerosis Impact Scale-29 showed statistically and clinically significant improvements in the STC group only. CONCLUSIONS: Participation in STC improved self-reported impact of spasticity more than UC and provided encouraging improvements in other measures.

Community Delivery of a Comprehensive Fall-Prevention Program in People with Multiple Sclerosis: A Retrospective Observational Study.

BACKGROUND: People with multiple sclerosis (MS) fall frequently. In 2011, the National Multiple Sclerosis Society launched a multifactorial fall-prevention group exercise and education program, Free From Falls (FFF), to prevent falls in MS. The objective of this study was to assess the impact of participation in the FFF program on balance, mobility, and falls in people with MS. METHODS: This was a retrospective evaluation of assessments from community delivery of FFF. Changes in Activities-specific Balance Confidence scale scores, Berg Balance Scale scores, 8-foot Timed Up and Go performance, and falls were assessed. RESULTS: A total of 134 participants completed the measures at the first and last FFF sessions, and 109 completed a 6-month follow-up assessment. Group mean scores on the Activities-specific Balance Confidence scale (F1,66 = 17.14, P < .05, η(2) = 0.21), Berg Balance Scale (F1,68 = 23.39, P < .05, η(2) = 0.26), and 8-foot Timed Up and Go (F1,79 = 4.83, P < .05, η(2) = 0.06) all improved significantly from the first to the last session. At the 6-month follow-up, fewer falls were reported (χ(2) [4, N = 239] = 10.56, P < .05, Phi = 0.21). CONCLUSIONS: These observational data suggest that the FFF group education and exercise program improves balance confidence, balance performance, and functional mobility and reduces falls in people with MS.