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[ARTICLE] Effects of a 6-month self-rehabilitation programme in addition to botulinum toxin injections and conventional physiotherapy on limitations of patients with spastic hemiparesis following stroke (ADJU-TOX): protocol study for a randomised controlled, investigator blinded study -Full Text

Abstract

Introduction Home-based self-rehabilitation programmes combined with botulinum toxin injections (BTIs) appear to be a relevant approach to increase the recommended intensive rehabilitation of patients with spasticity following a stroke. The literature highlights a lack of evidence of beneficial effects of this adjuvant therapy to reduce limitations of patients with stroke. The aim of this study is to assess the effects of a 6-month self-rehabilitation programme in adjunction to BTI, in comparison with BTI alone, to reduce limitations of patients with spasticity following a stroke.

 

Methods and analysis 220 chronic patients will participate to this multicentre, prospective, randomised, controlled, assessor blinded study. All patients will benefit from two successive BTI (3 months apart), and patients randomised in the self-rehabilitation group will perform in adjunction 6 months of self-rehabilitation at home. All patients continue their conventional physiotherapy. The main outcome is the primary treatment goal (PTG), which will be determined jointly by the patient and the medical doctor using Goal Attainment Scaling. Impairments and functions, quality of life, mood and fatigue will be assessed. Botulinum toxin will be injected into the relevant muscles according to the PTG. Patients in the self-rehab group will be taught the self-rehabilitation programme involving respectively 10 min of stretching, 10 min of strengthening and 10 min of task-oriented exercises, corresponding to their PTG. Compliance to the self-rehabilitation programme will be monitored.

Strengths and limitations of this study

  • This study is the first to assess the effects of a self-rehabilitation in addition of usual treatments over a long period (6 months).

  • This study will include a large sample with patients from 16 hospitals across all the country.

  • The design of this study (randomised, controlled, assessor blinded study) tends to meet the highest level of evidence.

  • This study would permit to apply recommendations to improve patients limitations with little additional cost to the already limited health system budget.

Background

Stroke is the second highest cause of death worldwide and the fourth leading cause of lost productivity (disability-adjusted life years) according to WHO. The annual incidence is around 130 000 new cases each year in France.1 Around half of survivors are left with some functional limitations as a result of multiple impairments including motor impairments with a loss of strength, stereotyped movements and changes in muscle tone.2 3 Following stroke, about one-third of people with motor deficits have complete upper limb recovery, one-third have a partial recovery, with capacity to carry a bag or to point to an object and, one-third have little to no recovery of function with often dependence for activities of daily living.4 Among impairments, positive signs of the upper motor neuron syndrome (spasticity, cocontraction and dystonia) are associated with active motor dysfunction and disabilities to use arm in daily living activities.5 6 Gait limitations following symptoms of upper motor neuron syndrome reduce also displacements and participation of patients with stroke.7 8 Although 65%–85% of stroke survivors regain the capacity to walk, their gait is slower and their cadence, step length and single support phase of gait cycle are reduced in comparison with healthy subjects.9 These spatio-temporal changes are associated with joint kinematics changes, such as reduced peak hip flexion,10 reduced peak knee flexion during swing (stiff knee gait)10 11 and reduced ankle dorsiflexion (equinus).10 Motor impairments are largely involved in these kinematic abnormalities, particularly spasticity of quadriceps reducing knee flexion in stiff knee gait11 and spasticity of the ankle plantar flexors contributing to the equinus.12

Physiotherapy has been shown to be effective for the treatment of motor impairment and the improvement of function following stroke.13 14 Different techniques have been developed, however, one has not been shown more effective than another.15 16 Nevertheless, it has been demonstrated that the intensity, the frequency and the specificity (to train specifically the task to improve) of physiotherapy is positively correlated with recovery.17–20 To increase the duration and the specificity of physiotherapy lead indeed to greater improvements in impairments and functional limitations. French et al 21 published a systematic review relating positive effects of repetitive functional task practice on upper and lower limb function in 1078 patients with stroke.21 Van de Port et al 22 showed indeed that intensive circuit training organised in specific workstations induced greater locomotor improvements than usual physiotherapy in 250 chronic outpatients with stroke.22 This likely suggests that patients do not attempt their maximal potential of recovery when they benefit of usual care. This means also that an adjuvant care might permit to the patients to reach their maximal capacity and thus reducing the impact of impairments and functional limitations. Moreover, many studies highlighted that improvements continue and are effective in chronic patients with stroke who follow intensive active rehabilitation.13 23 Currently, because of the constraints within the French health system, patients with stroke living at home usually receive only 1.7 sessions of 20–30 min of physiotherapy per week.24 These sessions, which last about 30 min, usually only consist of stretching and strengthening exercises. This contrasts with recommendations of intensive rehabilitation for chronic patients due to functional deteriorations observed when patients decrease or stop their rehabilitation.19 20 25 This suggests the necessity to develop novel approaches which could increase the intensity and specificity of rehabilitation for chronic patients with stroke living at home. A self-rehabilitation (SR) programme appears a relevant approach to increase the intensity of the oriented rehabilitation which is needed and further improve recovery of these patients.

The treatment commonly used to reduce spasticity and increase functions in patients with stroke is botulinum toxin injections (BTIs).12 26–28 In the upper limb, BTI appear associated with a global moderate treatment effect and depends of the parameters studied. A meta-analysis carried out by Foley et al 29 showed a relatively large effect size for the reduction of spasticity and the improvement of passive function and, a small effect size for the improvement of active functions such as prehension.29 This confirms the results of a previous international consensus statement in which authors consider BTI as effective for reduction of pain, deformity and improvement of washing and dressing (class I evidence, recommendation level A), but no clear benefit in active function (class III evidence, recommendations C).30 In the lower limb, several studies have evaluated the effects of BTI in the rectus femoris (RF) and triceps surae muscles in patients with stroke. Studies have shown that BTI in the triceps surae reduced passive resistance to ankle dorsiflexion, pain and the requirement of a gait aid and increased gait speed of patients with hemiparesis.31 32 An open-label study found a significant increase of 8° peak knee flexion during swing following BTI in the RF in patients with hemiparesis with inappropriate RF activity in mid-swing.33 However, there were no significant improvements in functional tests of gait capacity (gait speed, gait distance assessed during the 6 min walking test, stairs). Taken together, the results obtained in the upper and lower limbs after a single BTI session suggest that, although this treatment reduces muscle tone and increases passive function, its impact on active function is low and it does not improve activities of daily living. Some authors state that conventional outcome measures used in these previous studies are not suitable.30 34 35 They suggest using an individually based approach such as the Goal Attainment Scaling (GAS) which showed significant improvements following BTI.34 35 GAS determined the primary treatment goal which is the main treatment objective determined jointly by the patient and the therapist.

Several studies showed moreover that repeated BTI induce better improvements of muscle tone, active movements, functions and quality of life of patients with stroke than single injection.27 36–38

In view of all these studies, it appears essential to develop a combined therapy approach to improve the treatment of spasticity and functional activities in daily life. To increase the intensity of the oriented rehabilitation following BTI would be indeed relevant. Sun et al 39 highlighted greater improvements of spasticity, active function and use of the paretic upper limb of patients with stroke when a constraint-induced therapy is coupled with BTI in comparison with less intensive rehabilitation.39 Similarly, Roche et al showed that a 30 min daily SR programme of 4 weeks coupled with a single session of BTI in the lower limb significantly improved several gait-related activities compared with BTI alone.40 The SR programme was developed to combine safe and feasible exercises combining 10 min of strengthening, 10 min of stretching and 10 min of task-oriented gait-related exercises. Eighty-three per cent of the patients in the SR group carried out 33 min exercises per day more than 5 days per week.40 These results show that combining SR at home with BTI seems effective, well accepted and well tolerated. Results of these pilot studies with restricted sample suggest effectiveness of adding sessions of specific exercises following BTI in patients with stroke, which corresponds to the conclusions of two recent reviews.41 42 These reviews recommend however further study with large sample size, long duration and robust methodology.

The aim of this study is to assess the effects of a 6 months SR programme in adjunction to BTI, in comparison with BTI alone, to reduce limitations of patients with spasticity having a stroke. All previous results lead us to the hypothesis that the addition of a specific 30 min SR programme to repeated BTI and usual physiotherapy should increase the proportion of patients who attain their primary treatment goal (impairments and functions assessed with GAS) more than usual care (involving repeated BTI and conventional physiotherapy), in poststroke outpatients with spasticity. Secondary objectives are to compare the effects of the two therapeutic strategies on impairments and functional status, on quality of life, mood, fatigability and fatigue of patients with stroke and evaluate the time course of the effects. Another aim is to assess compliance with, and tolerability of the SR programme, and to define the characteristics of compliant and non-compliant patients.[…]

Continue —> Effects of a 6-month self-rehabilitation programme in addition to botulinum toxin injections and conventional physiotherapy on limitations of patients with spastic hemiparesis following stroke (ADJU-TOX): protocol study for a randomised controlled, inves… | BMJ Open

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