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Table 14.29 Pharmaceutical Agents for the Treatment of Spasticity in Children Post ABI

Author

Year

Country

Study Design

Sample Size

Methods Outcomes

Walter et al.

(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.

Guettard et al.

(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.

Van Rhijn et al.

(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.