Non pharmacological interventions for spasticity in multiple sclerosis.

BACKGROUND: Spasticity is commonly experienced by people with multiple sclerosis (MS), and it contributes to overall disability in this population. A wide range of non pharmacological interventions are used in isolation or with pharmacological agents to treat spasticity in MS. Evidence for their effectiveness is yet to be determined. OBJECTIVES: To assess the effectiveness of various non pharmacological interventions for the treatment of spasticity in adults with MS. SEARCH METHODS: A literature search was performed using the Specialised Register of the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Review Group on using the Cochrane MS Group Trials Register which among other sources, contains CENTRAL, Medline, EMBASE, CINAHL, LILACS, PEDRO in June 2012. Manual searching in the relevant journals and screening of the reference lists of identified studies and reviews were carried out. Abstracts published in proceedings of conferences were also scrutinised. SELECTION CRITERIA: Randomised controlled trials (RCTs) that reported non pharmacological intervention/s for treatment of spasticity in adults with MS and compared them with some form of control intervention (such as sham/placebo interventions or lower level or different types of intervention, minimal intervention, waiting list controls or no treatment; interventions given in different settings), were included. DATA COLLECTION AND ANALYSIS: Three review authors independently selected the studies, extracted data and assessed the methodological quality of the studies using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) tool for best-evidence synthesis. A meta-analysis was not possible due to methodological, clinical and statistical heterogeneity of included studies. MAIN RESULTS: Nine RCTs (N = 341 participants, 301 included in analyses) investigated various types and intensities of non pharmacological interventions for treating spasticity in adults with MS. These interventions included: physical activity programmes (such as physiotherapy, structured exercise programme, sports climbing); transcranial magnetic stimulation (Intermittent Theta Burst Stimulation (iTBS), Repetitive Transcranial Magnetic Stimulation (rTMS)); electromagnetic therapy (pulsed electromagnetic therapy; magnetic pulsing device), Transcutaneous Electrical Nerve Stimulation (TENS); and Whole Body Vibration (WBV). All studies scored 'low' on the methodological quality assessment implying high risk of bias. There is 'low level' evidence for physical activity programmes used in isolation or in combination with other interventions (pharmacological or non pharmacological), and for repetitive magnetic stimulation (iTBS/rTMS) with or without adjuvant exercise therapy in improving spasticity in adults with MS. No evidence of benefit exists to support the use of TENS, sports climbing and vibration therapy for treating spasticity in this population. AUTHORS' CONCLUSIONS: There is 'low level' evidence for non pharmacological interventions such as physical activities given in conjunction with other interventions, and for magnetic stimulation and electromagnetic therapies for beneficial effects on spasticity outcomes in people with MS. A wide range of non pharmacological interventions are used for the treatment of spasticity in MS, but more robust trials are needed to build evidence about these interventions.

Multidisciplinary rehabilitation following botulinum toxin and other focal intramuscular treatment for post-stroke spasticity.

BACKGROUND: Spasticity may affect stroke survivors by contributing to activity limitations, caregiver burden, pain and reduced quality of life (QoL). Spasticity management guidelines recommend multidisciplinary (MD) rehabilitation programmes following botulinum toxin (BoNT) treatment for post-stroke spasticity. However, the evidence base for the effectiveness of MD rehabilitation is unclear. OBJECTIVES: To assess the effectiveness of MD rehabilitation, following BoNT and other focal intramuscular treatments such as phenol, in improving activity limitations and other outcomes in adults and children with post-stroke spasticity. To explore what settings, types and intensities of rehabilitation programmes are effective. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (February 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 12), MEDLINE (1948 to December 2011), EMBASE (1980 to January 2012), CINAHL (1982 to January 2012), AMED (1985 to January 2012), LILACS (1982 to September 2012), PEDro, REHABDATA and OpenGrey (September 2012). In an effort to identify further published, unpublished and ongoing trials we searched trials registries and reference lists, handsearched journals and contacted authors. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared MD rehabilitation (delivered by two or more disciplines in conjunction with medical input) following BoNT and other focal intramuscular treatments for post-stroke spasticity with placebo, routinely available local services, or lower levels of intervention; or studies that compared MD rehabilitation in different settings, of different types, or at different levels of intensity. We excluded RCTs that assessed the effectiveness of unidisciplinary therapy (for example physiotherapy only) or a single modality (for example stretching, casting, electrical stimulation or splinting only). The primary outcomes were validated measures of activity level (active and passive function) according to the World Health Organization's International Classification of Functioning, Disability and Health. Secondary outcomes included measures of symptoms, impairments, participation, QoL, impact on caregivers and adverse events. DATA COLLECTION AND ANALYSIS: We independently selected the trials, extracted data, and assessed methodological quality using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE). Due to the limited number of included studies, with clinical, methodological and statistical heterogeneity, quantitative meta-analysis was not possible. Therefore, GRADE provided qualitative synthesis of 'best evidence'. MAIN RESULTS: We included three RCTs involving 91 participants. All three studies scored 'low quality' on the methodological quality assessment, implying high risk of bias. All studies investigated various types and intensities of outpatient rehabilitation programmes following BoNT for upper limb spasticity in adults with chronic stroke. Rehabilitation programmes included: modified constraint-induced movement therapy (mCIMT) compared with a neurodevelopmental therapy programme; task practice therapy with cyclic functional electrical stimulation (FES) compared with task practice therapy only; and occupational, manual therapy with dynamic elbow extension splinting compared with occupational therapy only. There was 'low quality' evidence for mCIMT improving upper limb motor function and spasticity in chronic stroke survivors with residual voluntary upper limb activity, up to six months, and 'very low quality' evidence for dynamic elbow splinting and occupational therapy reducing elbow range of movement at 14 weeks. Task practice therapy with cyclic FES did not improve upper limb function more than task practice therapy alone, only at 12 weeks. No studies addressed interventions in children and those with lower limb spasticity, or after other focal intramuscular treatments for spasticity. AUTHORS' CONCLUSIONS: At best there was 'low level' evidence for the effectiveness of outpatient MD rehabilitation in improving active function and impairments following BoNT for upper limb spasticity in adults with chronic stroke. No trials explored the effect of MD rehabilitation on 'passive function' (caring for the affected limb), caregiver burden, or the individual's priority goals for treatment. The optimal types (modalities, therapy approaches, settings) and intensities of therapy for improving activity (active and passive function) in adults and children with post-stroke spasticity, in the short and longer term, are unclear. Further research is required to build evidence in this area.

Multidisciplinary rehabilitation for follow-up of women treated for breast cancer.

BACKGROUND: Breast cancer is the most common malignancy in women worldwide. Multidisciplinary rehabilitation aims to improve outcomes for women but the evidence base for its effectiveness is yet to be established. OBJECTIVES: To assess the effects of organised multidisciplinary rehabilitation during follow-up in women treated for breast cancer. SEARCH METHODS: We searched the Cochrane Breast Cancer Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, CINAHL, AMED, PEDro and LILACS in December 2011. SELECTION CRITERIA: Randomised and controlled clinical trials (RCTs, CCTs, respectively) that compared multidisciplinary rehabilitation with some form of control intervention (such as a lower level or different type of intervention, minimal intervention, waiting list controls or no treatment, interventions given in different settings). DATA COLLECTION AND ANALYSIS: The type of data retrieved did not allow for quantitative synthesis and therefore a narrative synthesis was provided. The methodological quality of the included studies was evaluated by three authors using the risk of bias tool. MAIN RESULTS: Two RCTs, including 262 participants, met the inclusion criteria. Both trials scored poorly for methodological quality. There was 'low level' evidence that multidisciplinary rehabilitation produced short-term gains at the levels of impairment (that is range of shoulder movement), psychosocial adjustment and quality of life after breast cancer treatment (up to 12 months). No evidence was available for the longer-term functional outcomes for caregivers or the cost effectiveness of these programmes. It was not possible to suggest the most appropriate frequency and duration of therapy or choice of one type of intervention over another. AUTHORS' CONCLUSIONS: There was 'low level' evidence that multidisciplinary rehabilitation can improve the outcomes of people with breast cancer in terms of functional ability, psychosocial adjustment and participation in social activities. There was no evidence available on functional gain at the level of activity. This review highlights the limitations of RCTs in rehabilitation settings and the need for high-quality trial-based research in this area. Regular evaluation and assessment of breast cancer survivors for rehabilitation is recommended.

More than a black box of rehabilitation: Characterizing therapy programmes following botulinum toxin injections for spasticity in adults with stroke.

OBJECTIVES: To describe ambulatory rehabilitation programmes (physical and occupational therapy activities and interventions) following botulinum toxin injections for post-stroke spasticity using a stroke rehabilitation taxonomy. To explore the relationship between therapy provided and injected limb/s and treatment goals. DESIGN: Prospective, observational cohort study. PARTICIPANTS: Stroke survivors (n = 47) participating in ambulatory rehabilitation programmes following botulinum toxin injections for upper limb, lower limb or upper and lower limb spasticity. METHODS: Standardized therapy documentation forms were completed prospectively for each occupational and physical therapy session. Main outcomes were the proportion of total therapy time spent in various therapeutic activities; total sessions during which each intervention was used to facilitate the activities most time was spent in; and goals related to each activity category. Sub-analysis was carried out for participants, based on limb/s injected. RESULTS: Most time was spent in "upper extremity control" activities as the upper limb was more often injected. A large proportion of therapy time was spent in activities remediating "performance skills or body structure and function impairments". In the upper and lower limb, and upper limb groups 38.7% and 46.2% of goals, respectively, related to this activity category, but less than 10% in the lower limb group. Little time was spent in community participation and leisure activities, whilst over one-third of lower limb group goals related to this category. CONCLUSION: Ambulatory rehabilitation programmes following botulinum toxin injections for post-stroke spasticity varied depending on limb/s injected and reflected treatment goals to some extent.

Outcomes of ambulatory rehabilitation programmes following botulinum toxin for spasticity in adults with stroke.

OBJECTIVE: To examine the benefits of high intensity ambulatory rehabilitation programmes over usual care following botulinum toxin A (BoNT-A) for post-stroke spasticity in Australian adults. DESIGN: Prospective single centre, controlled clinical trial. PARTICIPANTS: Fifty-nine adults, median 61 years old and 2.5 years following stroke. METHODS: PARTICIPANTS were dichotomised into high intensity ambulatory rehabilitation programmes (≥ 3 × 1-h weekly sessions for approximately 10 weeks) or usual care programmes (≤ 2 × 1-h weekly sessions) following BoNT-A injections for spasticity. A blinded assessor completed outcomes at 0 (baseline), 6, 12 and 24 weeks. Primary endpoints: proportion of participants achieving ≥ 50% of their goals (using Goal Attainment Scaling: GAS) and GAS T-score change at 12 weeks. SECONDARY OUTCOMES: Modified Ashworth Scale (MAS), participant satisfaction, activity/participation measures and caregiver burden. RESULTS: Both groups showed significant improvement in goal attainment and participant satisfaction up to 24 weeks, with no overall between-group significant differences. There was, however, a statistical trend (p = 0.052) for participants to achieve more upper limb goals in the high intensity therapy group. GAS and satisfaction benefits persisted beyond the duration of spasticity reduction as measured by MAS. CONCLUSIONS: While patient-centred outcomes following BoNT-A injections for post-stroke spasticity were not influenced by intensity of ambulatory rehabilitation programmes, there was a trend for high intensity therapy to be associated with greater upper limb goal attainment. This suggests that the effects of more intensive therapy may be a modifier of the 'black box' of rehabilitation; however, further research is required to evaluate this effect and determine which elements of therapy programmes optimise post-BoNT-A outcomes.

Relevance and completeness of the International Classification of Functioning, Disability and Health (ICF) comprehensive breast cancer core set: the patient perspective in an Australian community cohort.

OBJECTIVE: To examine the relevance and completeness of the International Classification of Functioning, Disability and Health (ICF) comprehensive core set for breast cancer using patient reported disability in an Australian cohort. METHOD: Cross-sectional community survey of 85 women following definitive treatment for primary breast cancer. Everyday living problems reported by participants (using open ended questionnaires) were linked with ICF categories using 'linkage' rules. Participants rated 'Activities and Participation' and 'Environmental factors' components of ICF checklist using World Health Organisation qualifiers (0-4). The impact of breast cancer on health areas corresponding to 90 ICF categories in these two components was assessed; and compared with ICF categories within the comprehensive breast cancer core set. RESULTS: Participants identified 16 of 22 categories from 'Activities and Participation' and 11 of 23 categories (barriers) from 'Environmental factors' included in the comprehensive Core Set for BC, as relevant (≥ 10% of the participants). Median number of problems reported was 4 (IQR 1-9) and 1 (IQR 1-4) for 'Activities and Participation' and 'Environmental factors' categories', respectively. Thirteen additional relevant categories relating to mobility, major life areas, community civic life and societal attitudes currently not included in the breast cancer core set, were identified. CONCLUSION: The comprehensive breast cancer core set needs to incorporate issues important to survivors with breast cancer in post-acute settings, prior to its validation from a global perspective.