Influence of gait analysis on decision-marketing for lower extremity surgery

Long-term use of botulinum toxin type A in children with cerebral palsy: treatment consistency

G MOLENAERS MD PHD A,B, K DESLOOVERE PHD B,C,
A VAN CAMPENHOUT MD A,B, V SCHORKHUBE PT B, P PAUWELS MD D,
J DE CAT PT C, E ORTIBUS MD E, P DE COCK MD PHD E

  1. 1. Department of Musculoskeletal Sciences;
  2. 2. Clinical Motion Analysis Laboratory (CERM);
  3. 3. Department of Rehabilitation Sciences;
  4. 4. Centre for Human Genetics;
  5. 5. Department of Pediatrics, University Hospital of Pellenberg, Katholieke Universiteit Leuven, Belgium

Objectives: The aim of the study was to evaluate the stability of dosage, treatment intervals, and efficacy in long-term, multi-level, high-dosage treated children with cerebral palsy (CP) and to study the evidence for safe and stable response to this treatment. It was hypothesized that: (1) the mean total botulinum toxin type A (BTX-A) dosage does not increase; (2) the mean intervals between treatments; and (3) the efficacy
Do not decrease within the longitudinal follow-up.

Design: Retrospective cohort study.

Participants/Setting: Ten percent (n=106) of all patients treated with BTX-A (n=1020) at the multidisciplinary clinic for children with CP (referral centre) between 1996 and 2005, received at least four BTX-A treatment sessions.

Methods: Information on diagnosis, age at treatment, dosage, and target muscles was extracted for each patient and treatment session from the electronic patients files. Mean dosage, decrease/increase of dosage, treatment intervals for consecutive treatment sessions, and mean age at treatment sessions were evaluated for the whole treatment group and separated groups (diplegic, hemiplegia, quadriplegia). The Goal Attainment Scale (GAS) was defined for a subgroup of 38 patients, to evaluate the functional outcome of each treatment session. A mixed model procedure was used for repeated interval/ratio data, taking diagnosis into account. Unpaired t-test was used to evaluate the difference between mean age at first treatment.

Results: Patients were followed 4 years 6 months on average (range 1y8mo-8y10mo) and received four to 12 BTX-A treatment sessions. Seventy-nine percent of all treated patients had diplegia, 9% had hemiplegia, and 12% quadriplegia. Patients were treated with a mean dosage of 23.5 U/kg body-weight (SD 5.2) at first treatment with stable subsequent values (23.4[SD 5.5] at the second, 22.2 [SD 5.7] at the third, and 21.3 [SD 6.2] at the fourth session; not significant, p=0.1202). The mean age at first treatment was 4 years 6 months, with a majority of patients (76%) first treated within 2 and 4 years of age. Treatment intervals of 1 year 1 month (SD 8mo) remained stable within subsequent treatments. The majority of patients (94%) received multilevel treatment. The strategy changed at the third and fourth treatment sessions, when multi-level treatment decreased in favour of targeted treatment including two proximal levels. The mean GAS T-score at each session was significantly higher than the expected mean of 50, indicating a successful outcome.

Conclusions; Long-tem (repeated), high-dosage, multi-level BTX-A applications can be considered a safe, stable and successful treatment option for children with CP, thereby indirectly indicating the non-development of antibody formation.

 
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