Self Rehabilitation Combined With BTI on Upper Limb Clinical Trial
Official title:
Randomised Controlled Trial to Evaluate the Effect of a Self-rehabilitation Program in Addition to Usual Treatment for Spasticity on Upper Limb Function in Stroke
To show that the addition of a self-rehabilitation program to standard treatment, involving repeated BTI and usual physiotherapy, improves impairment and activity limitation of the paretic upper limb more than the control treatment (BTI + usual physiotherapy), in a randomised controlled study of patients with spastic hemiparesis following stroke.
Following stroke, 30% of patients are left with a "hemiplegic" upper limb meaning that they
are unable to carry out any movements with the limb and are thus partially or totally
dependent for all activities of daily living (dressing, washing, feeding etc). Another 40%
have some proximal recovery. These patients are able to carry out some movement of the
shoulder and sometimes the elbow. They can use the limb for some activities of daily living
such as carrying a bag or stabilising paper while writing. The last 30% recover a certain
degree of prehension, however their motor control is altered and they have impairments of
both the reaching and grasping phases.
Treatment for chronic stroke symptoms (more than 6 months post-onset) including impairments
and activity limitations is mostly based on physiotherapy and botulinum toxin injections
(BTI).
Physiotherapy : This treatment has been shown to be effective, and is essential to reduce
impairments and improve function in patients with hemiparesis following stroke (Robertson et
al, 2008 ; Bourgeais et al, 2010). Different methods exist, and comparative studies of the
most common ones have shown a similar effectiveness (Adal et al, 2006 ; Flansbjer et al, 2008
; Brazzelli et al, 2011, Durstine et al 2009). No conventional treatment has been shown to be
more effective than another. However, it has been demonstrated that the intensity and
specificity of rehabilitation techniques are positively correlated with motor recovery
(Gordon et al, 2004).
Intensity of rehabilitation: In 2006, a meta-analysis of 21 studies on the effect of muscle
strengthening post stroke showed that it improved active function and activities of daily
living (measured on different scales) following acute and chronic stroke (Ada et al, 2006).
Currently, a meta-analysis by Brazzelli et al. (2011) contains the largest collection of
data, with 32 studies and a total of 1414 participants. The studies included were on the
subject of cardiovascular training, muscle strengthening and mixed training
(cardiovascular+strength). The main outcome measures were the incidence of mortality and the
degree of dependence and disability. The results showed improvements following cardiovascular
training and mixed training. Strength training alone did not significantly improve mobility.
These results lead the American College of Sport and Medicine to recommend endurance and
strength training coupled with stretching for stroke patients.
Task-oriented training : Carr et Shepherd (1998) were the first to promote task oriented
training. More recently, Van de port et al, (2009-2012) evaluated 250 patients following 12
weeks of task-oriented circuit training (126 patients) or conventional physiotherapy (124
patients). All the patients were at least 6 months post stroke. The training consisted of
6-minute work stations with 8 different exercises, such as rising from a chair to reach
different targets, picking up objects from the floor while walking, kicking a ball, crossing
obstacles, ascending and descending stairs etc. Greater improvements occurred in the
task-oriented group for the six-minute walk test and the Stair test (time to ascend and
descend a flight of 10 stairs. Another meta-analysis (including 307 participants)
demonstrated that task-oriented training improves distance walked, gait speed and the Timed
Up and Go test (rising from a chair, walking 3 metres, turning and returning to sit) (Wevers
et al, 2009). These results show that training should involve practice of the specific
function to be improved.
Botulinum toxin injections : Botulinum toxin is a neurotoxin produced by the clostridium
botulinum bacteria. Seven different serotypes exist but only the A and B serotypes are used
in clinical practice. Botulinum toxin blocks the presynaptic release of neurotransmitter at
the neuromuscular junction. Focal transitory paralysis thus occurs in the injected muscle.
Its action lasts on average 3 months in striated skeletal muscle. The effect of BTI in the
upper limb depends on the parameters studied. A meta-analysis carried out by Foley et al,
2013 showed a relatively large effect size for the reduction of impairment and the
improvement of passive function. However, there was only a small effect size for the
improvement of functions such as prehension. This confirms the results of a previous study
(Sheean et al, 2010) which showed that the effect of BTI in the upper limb was only
significant for the reduction of impairment or the improvement of passive function, but not
active function.
These results were further confirmed in a study which used goal attainment scaling as an
outcome measure (Turner Stokes et al, 2010). Following BTI in the upper limb of hemiparetic
patients, there was a significant improvement in the goal attainment scaling score which was,
moreover, strongly correlated with the reduction in spasticity evaluated with the Ashworth
scale (most widely used scale for the evaluation of spasticity). The results also showed that
the goal was more often attained when it involved the improvement of a passive function than
an active function. The only study to have shown an improvement in prehension following BTI
involved combined treatment with constraint induced therapy (Sun et al, 2010).
Self-rehabilitation Two recent studies have shown that rehabilitation coupled with BTI could
have a significant effect on activity limitation: A pilot randomised controlled trial of 35
patients with spastic hemiparesis by Roche et al (2014) showed that a 30-minute, daily
self-rehabilitation program coupled with a single session of BTI in the lower limb
significantly improved several gait-related activities. The self-rehabilitation program was
developed to combine different types of exercises including: i) strengthening of the hip
flexors and extensors and the triceps sural; ii) stretching of the rectus femoris, hamstrings
and triceps sural and iii) task-oriented gait-related exercises including obstacle crossing
and slaloming. They showed significantly greater improvements in the experimental group than
the control group for maximal gait speed in the 10-metre walk test, distance walked in the
6-minute walk test and the time to ascend and descend a flight of stairs. Sun et al (2010)
carried out a randomised controlled trial which included 32 patients with stroke. They showed
that constraint-induced therapy in the paretic upper limb coupled with BTI significantly
improved prehension and reduced spasticity in the finger and wrist flexors more than BTI
coupled with standard therapy.
In summary Together, these results indicate that the addition of a self-rehabilitation
program to botulinum toxin injections is the most pertinent method to optimise the effects of
BTI and usual therapy. However, no study has yet evaluated the effects of the addition of a
self-rehabilitation program to treatment by BTI and usual therapy.
Moreover, this corresponds to a public health issue which is to provide a greater intensity
of rehabilitation within the constraints of the health system, including lack of funding and
lack of physiotherapists trained in this type of specialised rehabilitation.
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