An evaluator-blinded randomized controlled trial evaluating therapy effects and prognostic factors for a general and an individually defined physical therapy program in ambulant children with bilateral spastic cerebral palsy.

[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.

[AIM] 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 unit.

[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.

[CLINICAL REHABILITATION IMPACT] Both programs had a positive impact on the children's motor functioning. It is useful to involve older children more actively in the process of goal setting.