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Tolerance and effectiveness of a new dynamic hand-wrist orthosis in chronic stroke patients A.S. Andringa∗, Ingrid G.L. Van de Port and J.W.G. Meijer Revant Rehabilitation Centre Breda, Breda, The Netherlands Abstract.
PURPOSE: To evaluate tolerance of a new dynamic hand-wrist orthosis and effectiveness on the prevention of progressive wrist
contracture and spasticity after stroke.
METHOD: Chronic stroke patients (N = 6) with upper limb spasticity, who had not been able to endure a static orthosis, were
provided with a custom-made dynamic orthosis. Tolerance of the orthosis was evaluated by the daily wearing time, and self- reported pain and spasticity. Effectiveness was measured by contracture of wrist and finger flexor muscles, upper limb spasticity and use of spasticity treatment. Outcome measures were collected at time of fitting of the dynamic orthosis (baseline) and after RESULTS: Five patients could endure the dynamic orthosis without discomfort for 6 hours daily during the 6-month period.
Self-reported spasticity and pain decreased significantly (p < 0.05) compared to wearing the static orthosis. In comparison to baseline, the maximum passive wrist extension increased significantly from −29◦ to −12◦ (p < 0.05). Although, no significant change in spasticity was measured, the use of Botulinum Toxin injections decreased for two patients.
CONCLUSIONS: The majority of the included chronic stroke patients tolerated the new dynamic orthosis for at least 6 hours
daily and the use significantly reduced wrist contractures in a 6-month period.
Keywords: Stroke, upper extremity, contracture, spasticity, dynamic, orthosis 1. Introduction
Spasticity and contractures in the upper limb may sig- nificantly interfere with daily activities and hygiene After stroke, patients frequently experience prob- maintenance of the palmar skin (Franceschini, La lems in upper limb function (Nakayama, Jorgensen, Porta, Agosti, Massucci, & ICR2 group, 2010; Nichols- Raaschou, & Olsen, 1994). Patients with more severe Larsen, Clark, Zeringue, Greenspan, & Blanton, 2005; paresis in the upper limb muscles have a higher risk Sveen, Bautz-Holter, Sodring, Wyller, & Laake, 1999).
of developing spasticity in the arm (Kong, Chua, & Moreover, without appropriate attention, patients are at Lee, 2010; Urban, 2010) and contractures of the wrist risk to develop a clenched fist, a hand which is deformed into a fist by permanent shortening of flexor muscles of the fingers and soft tissue (Heijnen, Franken, Bevaart, Pandyan, Cameron, Powell, Stott, Uncorrected Author Proof One way to prevent contractures is applying pro- longed stretch to the flexor muscles by a static orthosis, ∗Address for correspondence: A.S. Andringa, MSc, Revant Reha- which is commonly used in rehabilitation for stroke bilitation Centre Breda, Brabantlaan 1, 4817 JW Breda, The Netherlands. Tel.: +31 76 5797900; Fax: +31 76 5331790; E-mail: patients with severe paresis in the upper limb (Farmer & James, 2001; Stoeckmann, 2001). To prevent a muscle 1053-8135/13/$27.50 2013 – IOS Press and the authors. All rights reserved A.S. Andringa et al. / Tolerance and effectiveness of a new dynamic hand-wrist orthosis from contracting, the muscle must be slightly stretched A secondary aim is to determine the effect of wearing for at least 6 hours a day (Burge, Kupper, Finckh, Ryer- a dynamic orthosis for six months on the contracture of son, Schnider, & Leemann, 2008; Tardieu, Lespargot, the wrist and finger flexor muscles, spasticity and use Tabary, & Bret, 1988). Long-term splinting by static orthoses in the prevention of contractures is widely accepted and recommended in guidelines for rehabilita- tion after stroke (Duncan et al., 2005; Miller, 2010; Van 2. Method
Peppen, Hendriks, Van Meeteren, Helders, & Kwakkel, 2007), but evidence is limited (Aoyagi & Tsubahara, 2004; Burge et al., 2008; Lannin & Herbert, 2003; Steultjens, Dekker, Bouter, Van de Nes, Cup, & Van In the present study with a longitudinal design, sub- jects were tested on three different time-points during In clinical practice, we see many stroke patients who a six-month follow-up period. Measurements were col- do not tolerate the static orthosis during the advised 6 lected at baseline (time of fitting the dynamic orthosis hours a day. Patients complain about an increase of pain (T0)) and, after three (T1) and six months (T2). At base- and spasticity, which makes it difficult to endure the line, retrospective information about the situation at the orthosis for a longer period each day. Approximately time of the use of the static orthosis was reported (T-1).
33–50% of stroke patients is not able to wear a static After obtaining the patient’s written informed consent, orthosis on a daily basis for 6 hours or more because of a custom-made dynamic orthosis was produced.
discomfort (XXX, XXX & XXX, submitted; Feldman, 1990). We hypothesize that the combination of a static device on one side and fluctuating spasticity levels on the other side will lead to this pain and discomfort. Dur- Between January 2010 and January 2011, all patients ing moments with high levels of spasticity, the wrist will who reported discomfort during usage of their static try to flex against the static orthosis which causes pain, orthosis to their rehabilitation physician or physiother- decubitus ulcers and an even higher muscle tone as a apist at XXX were screened for eligibility. Patients were result of a sensory pain stimulus. On other moments, the wrist will relax and there will be a lack of stretch. When static orthoses are poorly tolerated, contractures can – had a history of stroke resulting in upper limb develop and other, more aggressive interventions like spastic hemiplegia more than one year prior to Botulinum Toxin treatment and surgery are necessary to prevent the development of a clenched fist (Heijnen – were not able to wear a static orthosis for at least 6 et al., 2008; Ward, Roberts, Warner, & Gillard, 2005).
hours a day during a three-month period because To overcome problems of intolerance with the static of pain complaints or an increase of spasticity, orthosis, a dynamic orthosis has been developed by despite revisions of the orthosis by an orthopaedic XXX and XXX, XXX. This dynamic device gives a low-load prolonged stretch at a constant force to the upper limb which keeps the joint at end range. The – and were motivated to wear a dynamic orthosis for dynamic component ensures a slow, passive stretch to the wrist and finger flexor muscles. The resistance of the dynamic orthosis may be overcome by sudden changes Patients were excluded from the study if: in spasm, which allows the joint to flex, thereby reduc- ing the occurrence of pressure, skin breakdown and – deficits in language or cognitive impairments were pain. After relaxation, the hinge will go likely to interfere with the ability to cooperate in – they had a contracture affecting flexor muscles of erance of the new dynamic orthosis in Uncorrected Author Proof the spastic upper limb which leads to fitting prob- patients who did not tolerate a static orthosis because lems for the dynamic orthosis (fingers could not of secondary pain and spasticity. We hypothesized that be extended to 0 degrees and wrist could not be these patients will be able to endure the dynamic ortho- sis for the prescribed 6 hours a day without discomfort.
– if they had wounds at the affected upper limb; A.S. Andringa et al. / Tolerance and effectiveness of a new dynamic hand-wrist orthosis was slowly increased by the physiotherapist dependent on the muscle tonus in combination with the tolerance All assessments were made while the patient was in a sitting position. Outcome measures were collected by a trained physiotherapist at least three hours after the Fig. 1. Dynamic hand-wrist orthosis with Ultraflex hinge.
Primary outcome was tolerance of the dynamic orthosis measured by the daily amount of orthosis wear- ing time, and self-reported pain and spasticity. During the first three months, the actual daily orthosis wearing time was recorded in a diary delivered with the ortho- sis, in which time-on and time-off were registered by the patient or the caretaker who helped applying the orthosis. After six months (T2), patients reported their orthosis wearing time of the second three months in a Pain and subjective reported spasticity while wearing the static respectively dynamic orthosis was measured with a 100-mm visual analogue scale with 0 mm rep- resenting ‘no pain’ or ‘no spasticity’ and 100 mm representing ‘worst pain’ or ‘worst spasticity’. This – if they had medical problems, other than directly scale was used to score pain and spasticity experienced related to hemiplegia, which could influence the with the static (T-1) and dynamic orthoses (T1 and T2).
During all assessments the skin of the hand and fore-arm – or if they were hypersensitive for orthosis was inspected and adverse events were monitored.
Secondary outcome was the effect of the orthosis assessed on three different parameters. First, the con- tracture of wrist and finger flexor muscles was measured as passive wrist extension in degrees with the fingers All subjects were provided with a custom-made, in extension by using a goniometer. A brief stretch dynamic, palmar hand-wrist orthosis with Ultraflex into wrist extension was provided to all participants hinge (Ultraflex Systems Inc., Pottstown, PA). As before assessment. Second, spasticity in the elbow flex- depicted in Fig. 1, the dynamic component of the ortho- ors, wrist flexors and fingers flexors was assessed by the sis gives a low-load prolonged passive stretch to the Modified Ashworth Scale (MAS) (Gregson et al., 1999; wrist and a special finger shell gives little stretch to the Bohannon & Smith, 1987). Last, use of spasticity treat- fingers. The thumb is in a static position.
ment for the spastic upper limb was monitored during Subjects were instructed to wear the dynamic ortho- sis for at least 8 hours a day, every day of the week. The minimal clinically-worthwhile orthosis wearing time To summarize the results of the duration of wear- ing time descriptive statistics were provided for each patient. Pain and spasticity experienced with the static In the first three months of the intervention, phys- and dynamic orthoses were compared by employing iotherapy sessions in which patients were coached in a Wilcoxon’s signed rank test. Maximum passive wrist wearing the orthosis were held once every two weeks. In extension and spasticity baseline, follow-up at 3 months those first three months, the extension force of the hinge and 6 months were compared with a Friedman’s test.
A.S. Andringa et al. / Tolerance and effectiveness of a new dynamic hand-wrist orthosis Individual data of daily orthosis wearing time ∗Stopped wearing the dynamic orthosis after month 4.
All values = median [range]. ∗Compared with static orthosis, p < 0.05 (Wilcoxon); VAS: visual analogue scale.
Statistical analysis was performed using SPSS, version nurses were not able to fit the dynamic orthosis. After 18. Statistical significance was set at the 5% level.
four months, one patient stopped wearing the dynamic orthosis because this participant experienced a lack of improvement. The reason for stopping was clearly unrelated to the tolerability of the dynamic orthosis. In 3. Results
the first four months, this participant wore the ortho- sis for at least 6 hours a day, mostly every day of the week. This participant did complete the six-month Six stroke patients (5 male, 1 female; mean age 65 yr Reasons reported for wearing the orthosis inciden- (range 53–73); mean time post-stroke 64 months (range tally less than 6 hours a day or less than 7 days a week 22–110)) with spasticity in the upper limb after stroke were: special activities e.g. going out, shopping, swim- were included in the study. None of the patients were ming, cycling, or attending the hospital, problems with able to wear their static orthosis for the prescribed 6 the orthosis e.g. wearing clothes with too narrow sleeves hours a day because of pain or spasticity, even after to fit the orthosis, or lack of help to fit the orthosis, or revisions of the orthosis by an orthopaedic technician.
because of problems of tolerance e.g. pain in the fingers All were still at risk to develop a clenched first because or extensor-muscles, being tired of wearing the orthosis, of severe paresis and increased muscle tone of the upper skin eruption of the palmar skin. Two patients reported a minor adverse event by wearing the dynamic orthosis.
Both had a pressure ulcer (stage I) which was caused 3.2. Dynamic orthosis tolerability by closing the straps to tight while applying the ortho- sis. Pressure ulcers in both patients were disappeared at Individual data of daily orthosis wearing times can Table 2 presents complaints of pain and spasticity while using the static orthosis, and the dynamic ortho- sis at three-month and six-month follow-ups. There is a significant difference (p < 0.05) in self-reported they still wore the dynamic orthosis for more than 6 pain and spasticity when using the static compared to hours a day. In the first month, one of the patients was the dynamic orthosis in favour of the dynamic ortho- admitted to hospital for 25 days because of lung prob- sis. From these data we can conclude that all six lems. These days were excluded from analysis because patients could tolerate the dynamic orthosis for the pre- A.S. Andringa et al. / Tolerance and effectiveness of a new dynamic hand-wrist orthosis Measurements of passive wrist extension and spasticity before and during dynamic orthosis usage All values = median [range]. ∗p < 0.05 Friedman; MAS: Modified Ashworth Scale.
BTX: Intramuscular Botulinum Toxin-A injection.
scribed 6 hours a day without discomfort of pain and 4. Discussion
These results indicate that the newly developed 3.3. Effect of six-month dynamic orthosis usage dynamic orthosis, according to the low-load pro- longed stretch principle, was tolerated by chronic stroke Table 3 illustrates the effect of the dynamic ortho- patients who could not endure a static orthosis and sis on passive wrist extension and spasticity (MAS) was effective in significantly reducing wrist contrac- at three-month and six-month follow-up. After three tures. Also, pain and spasticity were less when using months, there was no significant difference in max- the dynamic orthosis compared to the static. These data imum passive wrist extension. Over the six-month indicate that the dynamic orthosis not only prevents intervention period, the maximum passive wrist exten- progressive wrist contractures but also decreases exist- sion significantly (p < 0.05) increased from −29◦ to ing contractures by lengthening the shortened wrist and −12◦. There were no differences in spasticity in the elbow, wrist, or finger flexor muscles after three or six To our knowledge, no studies to date have focused months of wearing a dynamic orthosis.
on the use of a dynamic orthoses in the prevention Paramedic services remained at the same level after and treatment of progressive wrist contractures after six months of intervention with the dynamic orthosis.
stroke. Two studies (McPherson, Becker, & Franszczak, Spasticity treatment changed for two patients during six 1985; Scherling & Johnson, 1989) showed a reduction months of dynamic orthosis usage (Table 4). Patient of hypertonus by dynamic splinting in the hemiplegic 1, who was dependent on three-monthly Botulinum arm in chronic stroke patients but they did not study Toxin injections, cancelled both three-monthly appoint- the effect on contractures. Despite the scarcity of stud- ments with the rehabilitation physician during the ies, more dynamic orthoses have been developed in the last few years (Farmer, Woollam, Patrick, Roberts, & Bromwich, 2005; Hoffman & Blakey, 2011) which might be due to the ineffectiveness of static orthoses.
three locations (m. biceps brachii, Uncorrected Author Proof Two recent systematic reviews (Lannin & Ada, 2011; longus and m. flexor pollicis longus), at a high dosage.
Tyson & Kent, 2011) demonstrated that static orthoses After the 6-month use of the dynamic orthosis, only one do not have an effect on preventing contractures or low dosed injection was required in the flexor palmaris in reducing spasticity. In contrast to these studies, we found a significant effect of the dynamic orthosis on A.S. Andringa et al. / Tolerance and effectiveness of a new dynamic hand-wrist orthosis muscle length in the wrist. For this reason, we think questionnaire over the last three months, which might that the objective improvement of reduced wrist con- be vulnerable for bias. In future studies, we suggest that tractures observed in the present study is mainly due actual wearing time should be monitored by a sensor to the new orthosis based on the low-load and pro- connected to the orthosis which records the time when longed stretch technique. Static rigid orthoses may the orthosis is in contact with the skin of the upper limb.
cause increased stress in the finger and wrist joints by fluctuations in spasticity levels which may lead to pain.
Our study confirms the lack of effect of a dynamic 5. Conclusion
orthosis on spasticity measured by the MAS reported by previous studies (Katalinic et al., 2010; Lannin et In conclusion, this study shows that a dynamic hand- al., 2011). Although no significant change in spasticity wrist orthosis is a feasible and effective alternative to was seen six months after intervention with the ortho- the static orthosis in patients who do not tolerate a sis, there was a difference in spasticity treatment during static orthosis. Dynamic orthoses caused less pain and the intervention period. One of the patients stopped the spasticity discomfort compared to the static orthoses.
three-monthly Botulinum Toxin injections and another In addition, the dynamic orthosis has a clinically- decreased the dosage and number of Botulinum Toxin worthwhile effect on wrist contracture after stroke. This injections since wearing the dynamic orthosis. This makes it a promising treatment method in contracture might indicate that the dynamic orthosis has some effect prevention and possibly even contracture treatment for on spasticity, but further research is needed.
Despite the fact that all included patients could not tolerate their static orthosis and stopped wearing it, only Acknowledgments
one patient stopped wearing the dynamic orthosis after 4 months. However, the reason was unrelated to the A special thanks to XXX and XXX of XXX for the tolerability of the orthosis. The orthosis did not meet development and revision of the dynamic orthoses.
the expectations of the patient who had expected the orthosis to decrease the level of spasticity in the upper arm and to improve, instead of maintain the length of Declaration of interest statement
wrist and finger flexor muscles. Because of a lack of improvement the patient decided to stop with the ortho- The authors report no declarations of interest.
sis intervention. In future, it is important to explain what a patient can expect and monitor if the possible effects meet the expectations of the patient.
We have to address several limiting factors of this study. The sample size of this study was small (n = 6) XXX, XXX & XXX (submitted). Long-term use of a static hand-wrist and results should be confirmed in larger studies. How- orthosis in chronic stroke patients.
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