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An evaluator-blinded randomized controlled trial studying therapy effects and prognostic factors for a general and an individually defined physical therapy program in ambulant children with bilateral spastic cerebral palsy [with consumer summary]
Franki I, Desloovere K, de Cat J, Tijhuis W, Molenaers G, Feys H, Vanderstraeten G, van den Broeck C
European Journal of Physical and Rehabilitation Medicine 2015 Dec;51(6):677-691
clinical trial
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Cerebral Palsy (CP) is characterized by a heterogeneous nature with a variety of problems. Therefore, individualized physical therapy might be more appropriate to address the needs for these children. AIMS: The first aim was to compare the effectiveness of an individually-defined therapy program (IT) and a general therapy program (GT) on gait and gross motor function in children with CP. The second aim was to evaluate interaction-effects, time-effects, treatment with Botulinum Toxin A, age, gross motor function classification scale (GMFCS), treatment frequency and quality as factors influencing outcome. DESIGN: An evaluator-blinded, randomized controlled trial SETTING: Outpatient rehabilitation POPULATION: Forty ambulant children with spastic bilateral CP (mean age 6 years 1 month) METHODS: All children were randomly assigned to receive either IT or GT over a 10 week period. Nineteen of these children were enrolled into a second and/or third program, resulting in 60 interventions. Primary outcome was assessed with the Goal Attainment Scale (GAS) for gross motor function goals and z-scores for goals based on specific 3D gait parameters. Secondary outcome included the Gross Motor Function Measure-88 (GMFM-88) scores, time and distance gait parameters, Gait Profile Score, Movement Analysis Profiles and time needed to complete Timed-Up-and-Go and Five-Times-Sit-To-Stand tests. RESULTS: There were higher, but non-significant GAS and z-score changes following the IT program compared to the GT program (GAS: 46.2 for the IT versus 42.2 for the GT group, p = 0.332, ES 0.15; z-score: 0.135 for the IT compared to 0.072 for the GT group, p = 0.669, ES 0.05). Significant time-effects could be found on the GAS (p < 0.001) and the GMFM-88 total score (p < 0.001). Age was identified as a predictor for GAS and GMFM-88 improvement (p = 0.023 and p = 0.044). CONCLUSION: No significant differences could be registered between the effects of the IT and the GT. The favorable outcome after the IT program was only a trend and needs to be confirmed on larger groups and with programs of longer duration.

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