Table 14.29 Pharmaceutical Agents for the Treatment of Spasticity in Children Post ABI
Author Year Country Study Design Sample Size |
Methods | Outcomes |
(2015) Switzerland Case Series N=3 |
Population: ABI: Hypoxia=3; Mean Age=4.0 yr; Gender: Male=2, Female=1; Mean Time Post Injury=64.3 d. Intervention: Patients received intrathecal baclofen pump implants and were monitored for a mean of 2,315 d (approximately 6.3 yr). Dosage increased from 117 mcg at baseline to 660 mcg at the study end. Assessments were conducted at baseline and annually for at least 5 yrs. Outcome Measure: Modified Ashworth Scale (MAS), Complication Rate. |
1. Spasticity on MAS decreased from baseline to post-treatment in the upper and lower extremities. 2. Five occurrences of pump-related complications were observed including two cases of skin protrusion, one case of infection, one case of lumbar cerebrospinal fluid leak, and one case of intractable spasticity requiring a pump replacement. |
(2009) France Case Series N=25 |
Population: ABI: TBI=12, Stroke=6, Brain Tumour=5, Anoxia=2; Mean Age=9.3 yr, Gender: Male=14, Female=11; Mean Time Post Injury=3.0 yr. Intervention: Patients received botulinum toxin type A (BTX-A) to lower or upper limbs, or both. Doses were given in accordance with the patient’s age and muscle size and did not exceed 10 U/kg or 300 U. All participants received physical therapy, occupational therapy and auto-exercises. Assessments were taken at baseline, 4 wk post-injection and 3 mo follow-up. Outcome Measure: Ashworth scale (AS), Zancolli Scale (ZS), Range of Motion (ROM). |
1. Following the injections, spasticity was significantly reduced on the AS from baseline to 4 wk (p<0.0001). 2. Quality of opening hand improved significantly according to the ZS (p<0.001). 3. Mean ROM (p=0.040) improved from pre-injection to 4 wk. 4. Overall, 68.6% of treatment sessions led to positive results, whereas 23.6% did not have as good as expected functional outcomes. |
(2005) Belgium PCT N=21 |
Population: TBI; Age Range=2.7 yr-19.8 yr; Gender: Male=15, Female=6. Group 1 (n=4): Mean Time Post Injury=35.8 mo. Group 2 (n=10): Mean Time Post Injury=11.3 mo. Group 3 (n=7): Mean Time Post Injury=18.0 mo. Intervention: Patients in Group 1 (spastic quadriparesis with impaired consciousness) received bilateral injections of botulinum toxin type A (BTX-A) to the hip adductors, knee and plantar flexors. Group 2 (patients with upper limb spasticity) received unilateral injections to the elbow, fingers, wrist flexors, and/or shoulder muscles. Group 3 (patients with lower limb spasticity) received bilateral or unilateral injections to the plantar, knees, hip flexors, and/or hip adductors. Following the injections, all patients received a cast or an orthosis with Groups 2 and 3 receiving additional physiotherapy, ergotherapy and functional exercises. Assessments were conducted at baseline, and at 1, 3 and 5 mo follow-ups. Outcome Measure: Modified Ashworth Scale (MAS), Range of Motion (ROM) Goniometry Assessment. |
1. All groups demonstrated improvements in spasticity on MAS from baseline to 1 mo follow-up. 2. At 3 mo follow-up, Group 1 demonstrated the greatest level of improvement in spasticity on MAS compared to baseline. Groups 2 and 3 also demonstrated improvements from baseline to 3 mo follow-up. 3. At 5 mo follow-up, Group 2 continued to demonstrate improvements in spasticity on MAS compared to baseline. Groups 1 and 3 also exhibited improvements compared to baseline, but improvements had declined in comparison to 3 mo follow-up. 4. Group 2 exhibited the greatest level of improvement in ROM with mean increases of 23o, 36o and 53o at 1 mo, 3 mo and 5 mo follow-ups compared to baseline. 5. ROM in Group 3 improved by a mean of 4o from baseline to 1 mo follow-up but then experienced a -6o decline at 3 mo follow-up and a -3o decline at 5 mo follow-up compared to baseline ROM. 6. Group 1 exhibited moderate improvements in ROM with mean increases of 5o, 7o and 2o at 1 mo, 3 mo and 5 mo follow-ups compared to baseline. |