An evaluator-blinded randomized controlled trial evaluating therapy effects and prognostic factors for a general and an individually defined physical therapy program in ambulant XXXX with bilateral @entity306 .

@entity1 @entity34 @entity306
BACKGROUND: @entity306 ( @entity306 ) 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 @entity1 . AIM: The first aim was to compare the effectiveness of an individually-defined therapy program (IT) and a @entity34 ( @entity34 ) on gait and gross motor function in @entity1 with @entity306 . 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 unit. POPULATION: Forty ambulant @entity1 with @entity306 (mean age 6 years 1 month). METHODS: All @entity1 were randomly assigned to receive either IT or @entity34 over a 10 week period. Nineteen of these @entity1 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 @entity34 program (GAS: 46.2 for the IT versus 42.2 for the @entity34 group, P=0.332, ES 0.15; z-score: 0.135 for the IT compared to 0.072 for the @entity34 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 @entity34 . 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. CLINICAL REHABILITATION IMPACT: Both programs had a positive impact on the @entity1 's motor functioning. It is useful to involve older @entity1 more actively in the process of goal setting.
