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An evaluator-blinded randomized controlled trial evaluating therapy effects and prognostic factors for a general and
I Franki1, K Desloovere, J De Cat
1Rehabilitation Sciences and Physiotherapy, Ghent University, Gent, Belgium - inge.franki@kuleuven.be.
Insights
Individualized therapy (IT) and general therapy (GT) showed similar outcomes for children with cerebral palsy (CP). While IT demonstrated a trend towards better results, further research with larger groups and longer durations is needed to confirm its effectiveness in improving motor function.
Area of Science:
- Rehabilitation Medicine
- Pediatric Neurology
- Biomedical Engineering
Background:
- Cerebral palsy (CP) presents with diverse challenges, necessitating tailored interventions.
- Individualized physical therapy (IT) may offer a more personalized approach compared to general therapy (GT) for children with CP.
Purpose of the Study:
- To compare the efficacy of IT versus GT on gait and gross motor function in children with CP.
- To investigate factors influencing outcomes, including treatment type, botulinum toxin A, age, GMFCS level, and treatment frequency/quality.
Main Methods:
- Evaluator-blinded, randomized controlled trial involving 40 ambulant children with spastic bilateral CP.
- Children were randomized to 10-week IT or GT programs.
- Outcomes assessed using Goal Attainment Scale (GAS), z-scores for gait parameters, GMFM-88, and various timed functional tests.
Main Results:
- No significant differences were found between IT and GT in GAS or z-score changes, although IT showed a non-significant trend towards higher improvements.
- Significant time-effects were observed for GAS and GMFM-88 total scores, indicating overall improvement over time.
- Younger age was a significant predictor of greater improvement in both GAS and GMFM-88 scores.
Conclusions:
- Neither IT nor GT demonstrated statistically significant superiority over the other in this study.
- The observed trend favoring IT suggests potential benefits that warrant further investigation in larger, longer-duration studies.
- Both therapy approaches positively impacted children's motor function, with active involvement of older children in goal-setting being beneficial.
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.
