Impact of Soft Splints on Upper Limb Spasticity in Chronic Patients with Disorders of Consciousness: a Randomized, Single-Blind, Controlled Trial

Brain Injury

ISSN: 0269-9052 (Print) 1362-301X (Online) Journal homepage: http://www.tandfonline.com/loi/ibij20

Impact of soft splints on upper limb spasticity in chronic patients with disorders of consciousness: A randomized, single-blind, controlled trial

Aurore Thibaut, Thierry Deltombe, Sarah Wannez, Olivia Gosseries, Erik Ziegler, Cyril Dieni, Maxime Deroy & Steven Laureys

To cite this article: Aurore Thibaut, Thierry Deltombe, Sarah Wannez, Olivia Gosseries, Erik Ziegler, Cyril Dieni, Maxime Deroy & Steven Laureys (2015) Impact of soft splints on upper limb spasticity in chronic patients with disorders of consciousness: A randomized, single-blind, controlled trial, Brain Injury, 29:7-8, 830-836, DOI: 10.3109/02699052.2015.1005132

To link to this article: http://dx.doi.org/10.3109/02699052.2015.1005132

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Download by: [Colorado State University] Date: 25 September 2015, At: 15:05 http://informahealthcare.com/bij ISSN: 0269-9052 (print), 1362-301X (electronic)

Brain Inj, 2015; 29(7–8): 830–836 ! 2015 Informa UK Ltd. DOI: 10.3109/02699052.2015.1005132

ORIGINAL ARTICLE Impact of soft splints on upper limb spasticity in chronic patients with disorders of consciousness: A randomized, single-blind, controlled trial

Aurore Thibaut1, Thierry Deltombe2,3, Sarah Wannez1, Olivia Gosseries1,4,5, Erik Ziegler6, Cyril Dieni2, Maxime Deroy2, & Steven Laureys1

1Coma Science Group, Cyclotron Research Centre and Neurology Department, University and University Hospital of Lie`ge, Lie`ge, Belgium, 2Motor Sciences Faculty, Catholic University of Louvain, Louvain-la-Neuve, Belgium, 3Physical Medicine and Rehabilitation Department, CHU Dinant – Godinne/UCL Namur (University of Louvain), Yvoir, Belgium, 4Center for Sleep and Consciousness, Department of Psychiatry, 5Postle Laboratory, Department of Psychology, University of Wisconsin, Madison, WI, USA, and 6Cyclotron Research Centre, University and University Hospital of Lie`ge, Lie`ge, Belgium

Abstract Keywords Objective: To assess the effectiveness of soft splints on spasticity and hand opening in chronic Disorders of consciousness, manual patients with upper limb spasticity and disorders of consciousness (vegetative state/ stretching, spasticity, splint unresponsive wakefulness syndrome-VS/UWS and minimally conscious state-MCS). Methods: In this prospective single-blind controlled trial, a blind evaluator assessed spasticity History (Modified Ashworth Scale and Modified Tardieu Scale), range of motion (ROM) at the metacarpophalangeal, wrist and elbow joints and the patients’ hand opening before and Received 12 May 2014 after soft splinting, manual stretching and a control condition (i.e. no treatment), as well as Revised 19 November 2014 60 minutes later. Accepted 5 January 2015 Subjects: Seventeen patients with chronic (43 months) disorders of consciousness were Published online 22 April 2015 included (five VS/UWS; seven women; mean age ¼ 42 ± 12 years; time since insult ¼ 35 ± 31 months). Patients received either passive splinting, manual stretching treatment or no treatment. Results: Thirty minutes of soft splinting or 30 minutes of manual stretching both improved spasticity of the finger flexors. An increase of hand opening ability was observed after 30 minutes of soft splinting. Conclusion: Thirty minutes of soft splint application reduces spasticity and improves hand opening of patients with chronic disorders of consciousness. Soft splinting is well tolerated and does not require supervision.

Introduction negative signs are muscle weakness, loss of dexterity and fatigue. Spasticity is generally defined as a velocity-depend- About one out of four patients with brain damage develop ent increase in muscle tone and can be easily clinically

Downloaded by [Colorado State University] at 15:05 25 September 2015 abnormal patterns of muscle activity within 2 weeks of their assessed [5, 6]. The occurrence of spasticity is difficult to insult [1], with spasticity primarily affecting the flexors and predict due to its high variability [7]. The prevalence of pronators of the upper limbs. Nowadays, there is no consensus spasticity does not seem to differ between upper and lower about the definition of spasticity. The most accurate definition limbs. However, higher degrees of spasticity (Modified of motor disorders arising after a brain injury is the ‘upper Ashworth Scale; MAS 43) are more frequently (19% of motor neuron syndrome’ which can be defined by positive patients) observed in the upper limb than in the lower limb and negative signs [2]. Spasticity is one of the positive signs muscles (6%), with the most frequently affected joints being between other motor symptoms which arise after lesions in the elbow (79%) and the wrist (66%) [8]. Moreover, spasticity the descending corticospinal system such as spastic dystonia is associated with muscle contracture, tendon retraction and (i.e. muscle’s constriction in the absence of any voluntary pain [9, 10]. Muscle contracture is a pathological condition movement), spastic co-contraction (contraction of both the characterized by an increase of soft tissues’ stiffness and is agonist and antagonist muscles resulting from an abnormal usually associated with the loss of elasticity and fixed pattern of commands in the descending supraspinal pathway), shortening of affected tissues which cause both loss of extensor or flexor spasms, clonus, exaggerated deep tendon range of motion (ROM) and increased stiffness around the reflexes and associated reaction [3, 4]. On the other hand, joint [11]. O’Dwyer et al. [12] showed that the resistance to passive stretch was associated with the presence of Correspondence: Aurore Thibaut, Alle´e du Six Aout, 8, 4000 Lie`ge, muscle contracture and this resistance could be due to the Belgium. E-mail: [email protected] presence of muscle contracture. Moreover, contracture arises DOI: 10.3109/02699052.2015.1005132 Impact of soft splints on spasticity in DOC 831

more easily if spasticity holds a joint in a shortened position [13]. Spasticity may contribute to contracture formation [11] and some studies confirm this association [14–17]. These symptoms increase muscular hyperactivity and may poten- tially worsen the functional recovery of patients with brain injury. For a complete review see (Thibaut et al., 2013) [18]. Treating spasticity is, therefore, of paramount importance, especially in patients who are not able to communicate, as is the case for many patients who recover from coma. Progress in acute neurocritical care has led to an increase in the number of patients surviving a severe brain injury. Whereas some recover quickly, others pass through various altered states of consciousness: coma (i.e. unconscious, no eye opening), vegetative state/unresponsive wakefulness syndrome (VS/UWS, i.e. eye opening, but still unconscious) [19, 20] Figure 1. Soft splint positioning. and minimally conscious state (MCS; signs of consciousness, but no communication) [21]. Any possible sources of pain must be relieved, since patients with disorders of consciousness (DOC) are able to perceive pain, but cannot express their Materials and methods feelings [22–24]. It is even more important to treat spasticity, Materials because the proportion of patients with DOC who suffer from this disorder reaches almost 90% and it seems to be correlated The soft splint is a form of roller splint that fits in the palm of with pain during care [25]. the hand (Figure 1). It was designed to overcome the vicious As these patients are unable to actively participate in position of the upper limb of patients who suffer from rehabilitation, passive techniques are mainly used to treat spasticity. The material used is polyurethane, with a density of spasticity. The mainstay of physical treatment is muscle 85 kg m3. The manual stretching of the upper limbs was stretching, which should be started as early as possible to performed as a conventional physiotherapy session. It was prevent muscle shortening. Physical therapy sessions com- conducted below the pain threshold to obtain the maximal monly involve passive ROM exercises or short posturing amplitude. Manual stretching always started from distal sessions. However, to prevent contractures in the long-term, (fingers and wrist) to proximal (elbow) joints. Patients were muscle stretching should be applied daily for several hours in triple flexion and the stretching aimed to extend the fingers, [26–28]. The disadvantage of manual stretching is the then the wrist and finally the elbow to their maximal required participation of a physiotherapist, which limits the amplitudes [36]. Therefore, the metacarpophalangeal and frequency at which it is applied. In addition, severe contrac- the wrist joints were constantly stretched during the 30 tures necessitate prolonged stretching that can only be minutes of the stretching’s session. achieved through the use of postures, splints or casts [29]. Spasticity was evaluated by means of the MAS [37] Rigid splints are often used as orthopaedic devices in patients (grades 0; 1; 1+; 2; 3; 4) and MTS [38] (grades 0–5) over the in VS/UWS and MCS, although, for this population of fingers, wrist and elbow flexors. Several differences exist patients, their efficacy is still questionable [30, 31]. Moreover, between the two scales. The MAS measures the level of they are poorly tolerated when used for long periods of time resistance to passive movement, but does not evaluate the [32] and their effectiveness remains controversial, as they velocity of passive joint movement, the angle of catching or seem to be of little use if they are implemented when the potential tendon retraction [39]. The MTS does take into Downloaded by [Colorado State University] at 15:05 25 September 2015 patient with brain injury already presents severe contractures account the velocity of passive joint movement and the angle and significant spasticity [33–35]. Moreover, rigid splints can of catching. In this scale, spasticity is assessed with three be harmful for patients with severe spasticity, because they velocities (low, normal and fast) and the angle of catching is may induce bedsores, oedema or circulatory troubles [32]. reported as the angle of retraction [38, 40, 41]. Although the Soft splints are a potential alternative, but at present they are MTS seems more accurate than the MAS and more used due rarely used. They may avoid these negative effects due to their to a better sensitivity to change of the catching angle [29], softness and still decrease spasticity and improve hand both scales were used because many patients with DOC do opening by relaxing the patient and maintaining their hands not present any angle of catching due to a severe tendon in an open position. retraction. Moreover, some studies assessing treatment’s The aim of the present study was to compare the effect on spasticity showed a modification of the MAS but effectiveness of a hand rolled soft splint on the upper limb not the MTS [42]. Nevertheless, it is now established that the spasticity of patients with DOC, compared to conventional MAS evaluates a combination of soft tissue contracture and manual stretching. It was hypothesized that: (i) soft splints spastic dystonia, in addition to spasticity itself [31, 43]. decrease spasticity of the finger flexor muscles, as assessed The ROM was measured at the level of the metacarpo- with the MAS and the Modified Tardieu Scale (MTS); phalangeal joints (neutral position ¼ 180), the wrist (neutral (ii) soft splints increase hand opening of patients and position ¼ 90) and the elbow (full extension ¼ 180), using (iii) manual stretching could have a higher impact on elbow standard and digital goniometers. Hand opening was assessed spasticity than splints. by measuring the passive major-palm distance. Assessments 832 A. Thibaut et al. Brain Inj, 2015; 29(7–8): 830–836

were always performed from distal to proximal, starting at Mann-Whitney U-tests to investigate the difference of MAS the metacarpophalangeal joints and continuing up to the scores according to medication (i.e. presence vs absence of shoulder. All assessments were made while the patients were pharmacological treatment). Correlations between MAS lying in bed. scores and time since insult was assessed with Kendall’s Tau tests. For parametric data (major-palm distances and Methods ROM), differences between changes occurring after the Patients were seen at either the University Hospital of Lie`ge treatment and 60 minutes later were analysed by ANOVA or at their nursing homes. Those admitted to the University with repeated measures (pre, post and 60 minutes post). When Hospital were subjects for a week-long behavioural, neuroi- a significant time effect was observed, a post-hoc analysis was maging and electrophysiological assessment of their level of performed using a t-test for paired sample. Non-parametric consciousness. Those who were in nursing homes were data (MAS and MTS) were analysed using Wilcoxon’s signed referred by their treating physicians. rank test. This study compared the difference between T1 and The inclusion criteria were: (i) aged over 18 years, (ii) in a T2; and T1 and T3. Statistical analysis was performed using VS/UWS or a MCS after a severe acquired brain injury Statistica 10.0 with statistical significance set at the 5% level, according to published diagnostic criteria [21, 44], (iii) in a Bonferroni-corrected for multiple comparisons (p50.025). VS/UWS or a MCS for at least 3 months, (iv) have stable vital This study further evaluated the possible impact of treatment, signs and (v) have a spastic pattern in flexion bending both diagnosis and aetiology on major-palm distance and ROM upper limbs (MAS 1). Exclusion criteria were: (i) have using a repeated-measures analysis of variance with one cutaneous or joint pathologic states in the upper limb (e.g. independent variable. The independent variable represented wound, bedsore or fracture), (ii) have a spasticity pattern whether patients were medicated or not, VS/UWS or MCS or in extension and (iii) demonstrate a hypersensitivity to if their injury had traumatic or non-traumatic origin. A Mann- polyurethane. Whitney U-test was used for the non-parametric measures The experimental protocol was approved by the local (i.e. MAS or MTS). ethics committee (University Hospital of Lie`ge). The family of each patient signed a statement of informed consent. Results Patients received a different treatment on each upper A total of 26 chronic patients with DOC were consecu- limb. Two treatments applied for 30 minutes (i.e., manual tively screened; seven patients suffered from a spasticity stretching, splint treatment or no treatment) were tested on pattern in extension and two patients had no spasticity each upper limb separated by 60-minutes of break. The order (MAS ¼ 0). Seventeen patients who fulfilled the selection of the applied techniques was randomized (ratio: 1:1:1). In criteria were included in this randomized, single blind and total, four techniques were tested in every patient, two for controlled study (five VS/UWS, 12 MCS; mean age ¼ 42 ± each upper limb to increase the number of applied techniques 12; time since insult ¼ 35 ± 31 months; seven women, see due to the small population of patients (17 patients and 34 Table I). measures). The protocol was divided in nine steps (Figure 2). The soft splint was well tolerated by patients. The results The protocol was performed by two physiotherapists and showed significant changes at the level of the metacarpopha- lasted 4 hours and 30 minutes. The first physiotherapist, the langean joints. No significant results were observed for the assessor, handled pre- (T1), post- (T2) and 60 minutes post- wrist and elbow. No differences were observed between treatment (T3) assessments alone in the patient’s room and patients in VS/UWS and MCS. left the room after the assessments. Then, the second physiotherapist, the experimenter, entered the room and Splint-stretching group (n 14) applied the stretching or the splint or control condition to ¼

Downloaded by [Colorado State University] at 15:05 25 September 2015 the patient (a different treatment on each upper limb) based on Regarding the finger flexor muscles, the MAS score a list built by a classifier (ration: 1:1:1). The assessor decreased significantly at T2 (post-technique) compared to physiotherapist stayed outside the room of the patient during T1 (pre-technique) after splint application (p ¼ 0.014; median the experimentation and was blinded to the treatment used (IQR) from 3.5 (1.25) to 2.5 (2.25)) and after the manual prior to the assessments. Three groups were formed based on stretching (p ¼ 0.022; median (IQR) from 2.5 (3) to 2 (2)). treatments received on one upper limb: (1) splint and manual At T3 (60 minutes post-treatment), however, no significant stretching (n ¼ 14), (2) splint and controlled condition improvement was observed for either technique (p ¼ 0.093; (n ¼ 12) and (3) manual stretching and controlled condition median (IQR) ¼ 3 (1.25) and p ¼ 1; median (IQR) ¼ 2.5 (n ¼ 8). (2.25), respectively; see Figure 3 and opening (i.e. major- To evaluate the influence of treatment and time since insult palm distance) increased significantly at T2 for the splinting on patients enrolled in the present study, this study used the (p ¼ 0.005; mean ± SD from 5.07 ± 4.32 to 7.46 ± 3.51), but

Assessments Assessments Assessments Assessments Assessments

30’ treatment 60’ break 30’ treatment 60’ break

Figure 2. Experimental protocol. Technique A ¼ splint; technique B ¼ manual stretching; technique C ¼ no treatment;assessments: physiotherapist 1; treatments: physiotherapist 2. DOI: 10.3109/02699052.2015.1005132 Impact of soft splints on spasticity in DOC 833

Table I. Clinical data of patients.

MAS Patient Diagnosis Age (gender) Aetiology Elbow joint Elbow Wrist MCP Anti-spastic treatment 1 VS/UWS 29 (M) Anoxia 490 211No 2 VS/UWS 37 (M) Anoxia 590 1 2 3 Diazepam, baclofen (oral) 3 VS/UWS 57 (M) TBI 490 300No 4 VS/UWS 48 (F) Ruptured aneurysm 490 412No 5 VS/UWS 45 (M) TBI 590 4 4 4 Dantrium, baclofen (oral) 6 VS/UWS 49 (F) Anoxia 590 4 5 4 Dantrium, baclofen (oral) 7 MCS 31 (M) TBI 490 4 2 3 Baclofen pomp 8 MCS 71 (F) Ruptured aneurysm 490 103No 9 MCS 30 (F) TBI 590 4 3 3 Baclofen (oral) 10 MCS 46 (M) Ruptured aneurysm 590 2 2 2 Baclofen (oral) 11 MCS 43 (F) Anoxia 590 2 3 2 Baclofen (oral) 12 MCS 31 (F) TBI 490 220No 13 MCS 46 (F) Ruptured aneurysm 490 211No 14 MCS 35 (M) Anoxia 590 4 5 3 Tetrazepam, baclofen, dantrium (oral) 15 MCS 30 (M) TBI 590 354No 16 MCS 51 (F) Ruptured aneurysm 490 414No 17 MCS 18 (M) TBI 490 442No

MCP, metacarpophalangeal; VS/UWS, patients in vegetative state/unresponsive wakefulness syndrome; MCS, patients in minimally conscious state; TBI, traumatic brain injury, F/M, female/male.

Eﬀect of splint on the hand muscles spascity Eﬀect of stretching on hand muscles spascity 4 4 ns ns * * 3 3

2 2

1+ 1+ MAS median

1 1

0 0 T1 T2 T3 T1 T2 T3 Time of assessment Time of assessment

Figure 3. Me´dian and interquartile range of Modified Ashworth Scale (MAS) scores at baseline (T1), after 30 minutes of treatment – splint or stretching (T2), and 60 minutes later (T3). Results are significant at p50.05. ns ¼ non significant. Downloaded by [Colorado State University] at 15:05 25 September 2015

not for the manual stretching (p ¼ 0.249; mean ± SD from T3 (p ¼ 0.486; mean ± SD ¼ 3.88 ± 3.29). Other variables 5.79 ± 4.49 to 6.11 ± 4.58). At T3, the values returned to (MTS, ROM) did not change significantly. No significant baseline for the splint group (mean ± SD ¼ 4.86 ± 3.79). No changes were found when the patients were not treated. significant changes were observed for the other variables No difference in terms of treatment, diagnosis or aetiology (MTS, ROM). No difference in terms of treatment, diagnosis was observed for MAS scores (p40.05), nor for major-palm or aetiology was observed for MAS scores (p40.05), nor for distance in term of treatment or aetiology. This study, major-palm distance (p40.05). however, found an interaction effect for diagnosis (p ¼ 0.027). Post-hoc Tukey’s test revealed a significant Splint-no treatment group (n ¼ 12) difference for patients in VS/UWS (n ¼ 4), but not for patients When wearing the splint, the MAS score of finger flexor in MCS (n ¼ 8) at T2 compared to T1, but no difference was muscles decreased significantly between T1 and T2 observed between T3 and T1. (p ¼ 0.014; median (IQR) from 2.5 (2) to 1.5 (2)) and this Stretching-no treatment group (n ¼ 8) reduction was maintained at T3 (p ¼ 0.022; median (IQR) ¼ 2 (1.5)). Hand opening (i.e. major-palm distance) increased This study did not find any significant changes for all the significantly in T2 (p ¼ 0.009; mean ± SD from 3.54 ± 3.49 variables of all tested joints, neither after stretching nor after to 6.17 ± 3.47), but the effect was not maintained at the absence of treatment. 834 A. Thibaut et al. Brain Inj, 2015; 29(7–8): 830–836

All results and p values, median, mean, interquartile range, assessing the fingers, then the wrist then the elbow. This standard deviation and delta are summarized in supplemen- order could increase the chance to observe an effect on the tary material (Tables S1 and S2). fingers flexor muscles. Moreover, manual stretching can generate pain and increase spasticity. Indeed, in this study, the physiotherapists often had to decrease the stretching due to Discussion pain signs (e.g., grimaces, crying, restlessness). The main results showed that the soft splint and manual In both groups ‘splint-stretching’ and ‘splint-no treatment’, stretching reduced spasticity of finger flexors muscles in the soft splinting improved hand opening (major-palm patients with DOC. distance). The thickness of the splint allowed metacarpopha- A decrease in spasticity was observed after 30 minutes langeal and interphalangeal joints to be positioned near their of soft splinting and after 30 minutes of manual stretching. maximum stretching position. In patients with DOC, it is A long-lasting effect of the soft splint was only observed in important to maintain a good hand opening, first from a the group ‘splint-no treatment’. The results of manual hygienic standpoint, to avoid problems of maceration, pres- stretching are in line with previous studies that report the sure sores or injury caused by driving nails into the palm transient effect of manual stretching in children with DOC and also to facilitate nursing. In addition, if patients [45]. Other studies also showed the direct effect of manual recover cognitively, it is important that they are able to stretching in reducing spasticity for post-stroke patients [46], mobilize their fingers to grasp objects, in order to maximize children with cerebral palsy [47] and traumatic brain injury their autonomy. [48], but its effect fades after 30 minutes. Gracies et al. [49] For the group ‘splint-no treatment’, better improvement tested the effectiveness of wearing a soft splint (a glove in of hand opening (i.e. major-palm distance) was observed Lycra) for 3 hours in 16 acute patients with stroke. They after 30 minutes of splinting for patients in VS/UWS than showed that this glove provided comfort to patients by for patients in MCS. At the individual level, this study reducing spasticity (MAS) in flexion of the wrist and fingers found that two patients in VS/UWS improved substan- and improving wrist posture. The lasting effect of the soft tially compared to the 10 others, VS/UWS (n ¼ 2) and MCS splint in the ‘splint-no treatment’ group may be interpreted (n ¼ 8) (hand opening increased by 5 and 10 cm, respect- by the comfortable aspect of the splint, which could be ively), which may have had an influence on the results. relaxing. Unlike manual stretching, where the upper limb None of them were taking anti-spastic medication at the is mobilized, putting on a soft splint is less likely to time of assessment and none showed tendon retraction in cause pain, which could induce a spastic reaction [50]. the upper limbs. This could explain why they reacted Thus, when the splint is removed, the patient is relaxed and well to the splint. Nevertheless, as the sample size is very this relaxing effect can last longer. The advantage of splinting small (four VS/UWS compared to eight MCS), the results as compared to manual stretching is the duration of its must be interpreted carefully. application. One of the limitations of this study is the small number of The results are consistent with those of Gracies et al. [49]. patients and the results must interpreted with caution. Further The advantages of soft splints are that they are easy to studies should assess the effect of soft splints in a larger group place, comfortable and flexible and allow patient contraction of patients with DOC, as well as in both the acute and chronic (e.g. grasping reflex or muscles contraction) without resist- stages. ance. Thus, they can be worn for hours without pain and without inducing a grasping reflex or muscle cramps. In Conclusion addition, compared to rigid splints, the risk of injury and bedsores are reduced. Indeed, rigid splints are often diffi- This is the first study that compares soft splints and manual cult to place, especially in patients with severe spasticity and stretching in patients with chronic DOC. Soft splints and Downloaded by [Colorado State University] at 15:05 25 September 2015 tendon retraction, for whom hand opening and access to manual stretching both transiently reduced spasticity of the the palm is frequently difficult. Furthermore, a study flexor finger muscles. The soft splint, however, was the only conducted by Lannin et al. [34] showed that the rigid treatment able to improve hand opening. Thanks to its splints were not effective against spasticity. In patients comfort and simple application, soft splints could be easily with DOC, using a soft and comfortable splint should be applied in patient’s daily cares. Further studies of the long- recommended, since they are not able to communicate their term effects of wearing these splints are required prior to their pain feelings. Moreover, in cases of abrupt muscle contrac- introduction in daily clinical practice, but they have shown tion, soft splints can adapt themselves to the increase of promise in this study of upper limb spasticity. patient over-activity. Thanks to this adaptation, spasticity is not increased. Acknowledgments The soft splint failed to show an improvement on We are grateful to Serge Devreese from Vigo Group for spasticity and ROM of the wrist and elbow. This is logical technical assistance with soft splint. as the splint extended the fingers, but had no direct action on the wrist or elbow. Nevertheless, manual stretching also failed Declaration of interest to decrease the spasticity of the wrist and elbow joints, even if all the joints have been maximally elongated. This could The study was supported, in part, by Vigo Group, Belgium. be due to the order of joint assessment, since the physiother- The company put soft splint at our disposal but provided no apist who performed the evaluations always started by financial support, had no control over the data analysis and DOI: 10.3109/02699052.2015.1005132 Impact of soft splints on spasticity in DOC 835

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