|ORIGINAL CONTRIBUTION: REHABILITATION CLINIC IN CEREBRAL PALSY
|Year : 2015 | Volume
| Issue : 1 | Page : 4-7
Clinical outcome with Botulinum toxin-A in spastic cerebral palsy children with equinus gait
Raj Kumar, Sanjay Wadhwa, U Singh, SL Yadav
Department of Physical Medicine and Rehabilitation, AIIMS, New Delhi, India
|Date of Web Publication||26-Oct-2015|
Department of Physical Medicine and Rehabilitation, AIIMS, New Delhi
Source of Support: None, Conflict of Interest: None
Objective: Analysis of spastic equinus gait, ankle movements, and spasticity change in Indian cerebral palsy (CP) children. Design: Prospective study with follow up at 2 weeks and 2 months after injection. Setting: Department of Physical Medicine and Rehabilitation, AIIMS, New Delhi between 2009 and 2011. Participants: 22 Spastic CP children (12 diplegic and 10 hemiplegic), 14 males and 8 females aged 2-8 years (mean 4.44 years) having gastrocnemius spasticity with equinus gait. Intervention: Botulinum Toxin-A marketed as Botox® (Allergan, Inc.) was administered in both the medial and lateral heads of gastrocnemius. Dosage: 4 Unit/kg/muscle, maximum of 50 U per injection site, 50 U/ml with 0.9% normal saline dilution. After injection, the children continued participating in routine rehab exercise therapy and provided ankle foot orthosis. Main Outcome Measure(s): Temporospatial parameter of gait (stride, step length, cadence, velocity, percentage contact of foot with ground), Spasticity as per modified Ashworth Scale, active and passive range of motion at ankle. Results: Significant improvement (n = 34, P < 0.0001) noted in foot contact % (50.29 to 80.08), ankle active (−16.32 to −2.71) and passive (11.03 to 19.63), range of motion and, gastrocnemius spasticity (2.97 to 2). Other gait parameters (n = 22) such as stride length, cadence, velocity, and step length did not show any statistical change. Parents felt subjective improvement in >90% of children in terms of comfort, ease of care, and walking. The improvement lasted for 2 months. Conclusions: Botulinum Toxin-A injection is effective in treatment of equinus gait with easy OPD procedure and minimal side effects which are very tolerable.
Keywords: Botulinum toxin-A, cerebral palsy, equinus, gait, spastic
|How to cite this article:|
Kumar R, Wadhwa S, Singh U, Yadav S L. Clinical outcome with Botulinum toxin-A in spastic cerebral palsy children with equinus gait. Astrocyte 2015;2:4-7
|How to cite this URL:|
Kumar R, Wadhwa S, Singh U, Yadav S L. Clinical outcome with Botulinum toxin-A in spastic cerebral palsy children with equinus gait. Astrocyte [serial online] 2015 [cited 2022 Jul 3];2:4-7. Available from: http://www.astrocyte.in/text.asp?2015/2/1/4/168241
| Introduction|| |
Cerebral palsy (CP) is the most common motor disorder in children, occurring in about 2 per 1000 live births. It is characterized by aberrant control of movement and posture, appearing early in life (secondary to central nervous system lesion damage or dysfunction) and not the result of a recognized progressive or degenerative brain disease. Based on neuromuscular deficit, CP can be classified as spastic (most common type), dystonic, dyskinetic, atonic, and mixed. Spasticity in CP results in defective walking patterns such as scissoring, crouched gait, and equinus gait. Equinus or toe walking occurs due to calf muscle tightness. These gait patterns can often deteriorate during development without proper treatment. Therefore, anti-spasticity treatment plays an important role in CP.,, There are numerous treatment options available for spasticity management, which include physical and occupational therapy, orthosis, oral medications  (such as baclofen, tizanidine, dantrolene), chemodenervation, tendon lengthening, and dorsal rhizotomy. Thus, a stepped up management protocol is adopted, beginning with the more conservative options and reserving surgical option for older children and those cases where stiffness and progressive deformities continue to hamper rehabilitative treatment. Chemodenervation is most commonly performed using Botulinum toxin-A (BoTx-A) and has the potential advantages of having a relatively focal, reversible effect with a wide safety margin. Intramuscular BoTx-A injection denervates the muscle affected by spasticity and hypertonicity by inhibiting acetylcholine release from the neuromuscular junction. The denervation temporarily reduces muscle tone and provides an opportunity to effect changes in motor learning and cortical motor organization. Many researchers have assessed the efficacy of this intervention by different outcome assessment scales. Most randomized controlled trials on the effects of BoTx-A injections have focused on spasticity, which is most commonly assessed by the modified Ashworth Scale (MAS) and limitations in range of motion (ROM). The level of function has been assessed by observing gait or reviewing the results of motor and functional outcome scales. There is a scarcity of literature reporting effects of BoTx-A on gait patterns in spastic CP children. This study was conceptualized to evaluate the effects of BoTx-A on equinus gait of paediatric spastic CP patients and quantify the changes in spasticity and (ROM).
| Methods|| |
This was a prospective study with follow ups at 2 weeks and 2 months after injection. Spastic CP children were recruited into the study from the outpatient clinic at the Department of Physical Medicine and Rehabilitation (PMR), AIIMS, New Delhi. Inclusion criteria were (1) Spastic CP patients with involvement of gastrocnemius (toe walking), (2) Age 2-8 years, and (3) Willingness of guardian to participate. Children were excluded if there was (1) Fixed equinus contractures or previous surgery on gastrosoleus, (2) Bleeding disorder and, (3) Previous treatment with BoTx-A within 6 months, (4) Concomitant treatment with phenol, alcohol or any neurolytic procedures, (5) Known allergy to BoTx-A, (6) Spasticity not interfering with walking, (7) Cognitive dysfunction to such an extent that the patient will not be able to cooperate or follow instructions.
Ethical clearance was obtained from the Institutional Ethical Committee. The parents/guardians of patients were explained about the study and their written consent was taken. The children were evaluated (history and physical examination) and outcome measure including Gait parameters (stride, step length, cadence, velocity, percentage of foot contact with ground), active ROM (AROM), passive ROM (PROM) at ankle (measured by goniometry), and gastrocnemius spasticity (by MAS) were noted. For simplification and easy quantification of foot contact part of physician rating scale (PRS) in busy OPD setting measurement of the percentage of foot contact, length antero-posteriorly from heel to toe was taken. Percentage of foot contact length was measured by direct floor technique by applying chalk powder on the sole of children. Children were asked to walk over a measured 10 meter distance. Out of the 3 best measurements median value was taken. Number of steps and time taken to cover the 10 meter distance was noted and then cadence, velocity, and step length were calculated arithmetically. Subjective assessment questionnaire in terms of comfort (feeling better than earlier), ease of care, and walking was administered. Answer was taken as Yes/No. Follow up was done at 2 weeks and 2 months. At each follow-up both objective and subjective outcome measures were noted. No change in anti-spasticity treatment was done during the course of the study.
BoTx-A marketed as Botox ® was used (Allergan, Inc.) in this study in all patients because it is easily and widely available. Dosage: 4 U/kg/muscle with maximum of 50 U per injection site divided between both heads of gastrocnemius as 50 U/ml with 0.9% normal saline dilution. Injection procedure: It was done on OPD basis. Attention of the child from fear of injection was diverted (such as songs played on mobile phones, engaging the child in talking, telling the child stories) and then the injection was given under complete sterile and aseptic condition. In some very anxious children, sedation with syrup promethazine hydrochloride or triclofos was given. Injection were given by 1 ml tuberculin syringe with 26 gauge needle. Localization technique was solely on anatomical basis where muscle belly is most prominent, i.e., at the site of motor end plate and localization of the injecting needle through fascia of the target muscle at 5-10 mm depth. Patients were observed for 1 hour postinjection to evaluate possible adverse events (pain, bleeding, rash, allergic reaction, and other concerns, if any) and Afterwards, patients were discharged but they were asked to contact over mobile phone with concerns regarding possible side effects. Patients were followed up at 2 weeks and 2 months, and both objective and subjective outcomes were noted. After BoTx-A treatment, the children continued participating in routine physical therapy throughout the study period as doing earlier. All children were provided Ankle foot orthosis (AFO) (plastic) that included solid ankle and articulated type as needed.
Data was analyzed by SPSS20 and presented as mean (SD), frequency, and percentage. Changes within continuous variables following normal distribution was analyzed by repeated measure ANNOVA followed by Bonferonni correction, and data not folowing normal distribution were analyzed by Friedman test followed by multiple comparison using Wilcoxon signed rank test with Bonferroni correction. P value <0.05 was considered as significant.
| Result|| |
A total of 22 patients (12 diplegic and 10 hemiplegic), 14 males and 8 females, completed the study. Mean age was 4.44 years. 12 diplegic patients were given injection in both gastrocnemius. All hemiplegic patients (7 left and 3 right hemiplegic) were given BoTx-A injection in respective gastrocnemius muscles only. A total 34 gastrocnemius muscles were injected [Table 1], [Table 2], [Table 3] and [Figure 1], [Figure 2], [Figure 3].
|Figure 2: ROM at Ankle n = 34; P < 0001. Active Dorsiflexion (ADF) and Passive Dorsiflexion (PDF)|
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Subjective improvement was noted in 21 out of 22 patients (96.4%); parents felt comfortable in all 22 out of 22 cases in terms of ease of care (100%); and 20 out of 22 cases reported improved walking (92.9%) at 2 weeks which remained till 2 months post-injection. Only one patient reported adverse effect as flu-like symptoms (fever) 1 day after the injection, which responded within 2 days after taking paracetamol.
| Discussion|| |
Treatment with Botox was effective in correcting the position of the feet, as shown by the increased percentage contact of the foot, increased AROM and PROM of the ankle joint, and decreased gastrocnemius spasticity, thus comparing similarly with the findings of various previous studies.
In a study by El-Etribi et al., the BoTx-A group demonstrated statistically significant decrease in spasticity, improved gait function, and improved ROM. Koman et al. compared BoTx-A (n = 56) and placebo group (n = 58). They found that AROM at ankle was significantly greater in BoTx-A treated group at 4 weeks and 12 weeks (P < 0.05). Fazzi et al. observed a reduction in spasticity, increase in joint mobility as reflected in the gait pattern, selective motor control in foot dorsiflexion, and the acquisition of new motor abilities. Many other studies have shown similar reductions in tone, and improvements in ROM, gait.,, Carlos et al. (n = 20) reported improved ambulation and equinus gait pattern and physician rating scale (PRS) (P < 0.001) with BoTx-A. The heel-ground distance was significantly decreased.
We also observed an improvement on the foot contact component related to PRS scale. Physiological explanations for this adjustment in the feet include not only weakening of the gastrocnemius but also the increase in length of the gastrocnemii muscle-tendon unit, the shortening of the antagonist muscles, or a combination of these events. Any of these effects could be the direct result of chemical denervation caused by BoTx-A, and it is unlikely that they would occur spontaneously. Gait velocity, a matter of discussion with BoTx-A effect, actually decreased in follow ups (especially 1st), although statistically not significant. After newly achieved decrease in gastrocnemius spasticity, now child/parents main focus was on placing of foot as much as possible on the ground, which results in decreased number of steps/minute or decrese in ambulation speed. Another reason could be that the children having gastrocnemius spasticity tends to have smaller area of foot contact over the ground, making them to "catch" balance by reflex increase in cadence. Further increase in cadence during 2nd follow up may be attributed to learning the new gait pattern which boosts child confidence, hence improving gait velocity and cadence, possibly due to established reduction in spasticity.
Although the effects of BoTx-A are seen primarily in reduction of hypertonia, the changes in tone can improve the child's balance, strength, motor control, and fixed contractures. It is observed in our study that the increased effect of BoTx-A at 2 months could also be related to the results of more aggressive physical exercises. These are clear arguments for intensifying exercise therapy after the application of BoTx-A to achieve better results in the long term ,, as our patients did and could be able to tolerate easily. Therefore, reduced spasticity following BoTx-A applications can delay the need for surgery, thus reducing the possibility of recurring deformities.,
A study by Baker et al. showed more than half of the parents reported good or minimal improvement. In our study, parents reported subjective improvement in more than 90% of all cases that might be explained by younger children (mean age 4.44) and less strict subjective criteria followed in this assessment.
Emilie Guettard et al. did not report any serious side-effects, and whatever occurred were mild and transient. In our study, only one patient had low grade fever. These findings are consistent with the published reports of Botox ® use in children with cerebral palsy.,, This reveals that if BoTx-A is injected properly, adverse effects are very minimal.
| Conclusion and Limitations|| |
BoTx-A injection of gastrocnemius muscles in children with CP is effective in the treatment of spastic equinus pattern. The treatment was feasible and can be easily implemented in outpatient settings. Injections were well tolerated and yielded minimal adverse events. Study limitations were short follow up without control group and un-verified extent of physical exercises and AFO wearing time.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3]