Report of a Clinical Trial
What role does physical therapy have in improving the quality of life of children with cerebral palsy? Generations of experience support the concept that it plays an important role in both (1) improving function and (2) in preventing deterioration in the existing status of the person. But does it? For one? The other? Both? Does it principally improve the person’s performance or does it help support the caregiver’s aspirations? Is functional improvement maintained after discontinuation of therapy or does improvement require a lifetime of therapy? Are there subgroups for whom therapy is important and other groups for whom therapy is of marginal usefulness? Does the “type” or intensity of therapy make a difference? These, plus a dozen other questions need to be asked and studies done to provide answers. To date, when the questions were asked, the replies were based on personal experiences or professional consensus; rarely on well-designed studies.
However, a beginning is being made in exploring two of the strategies used in physical therapy: periodic therapy vs. intensive therapy; and who is setting the goals of therapy? A multi-site, randomized evaluation has been completed to determine whether motor function (muscle control) and performance (task accomplishment) are improved by use of intensive therapy and by collaborative goal setting agreed to by the child, the parents and the therapist. (1) 56 children with “bilateral cerebral palsy” (needing assistance with mobility) were studied; the children were between 3 and 12 years of age. Equal numbers and types of children were assigned to one of four strategies:
Strategy 1: Continuation of the present pattern of physiotherapy ranging from one to several hours/month with therapists establishing aims;
Strategy 2: Intense therapy of one hour/day, Monday through Friday with therapists establishing aims;
Strategy 3: Group (1) above with collaborative setting of goals (therapists and caregivers);
Strategy 4: Group (2) above with collaborative setting of goals (therapists and caregivers). The specific format of physiotherapy already being used for each child was not changed; it included a variety of procedures including the Bobath approach, conductive education, a musculo-skeletial approach and a combination of approaches (“eclectic”). The children were first evaluated during 6 months of no change in the treatment plan, then evaluated during the following 6 months after being assigned to one of the four trial groups, and finally after 6 months of having returned to the original plan of treatment. During this 18 month period, changes were measured in motor function and performance.
The results were: no changes of significance in already existing motor function or performance in any of the four groups during both the treatment period or after 6 months of post treatment observation. There was a trend towards improvement during treatment in the intensive therapy group (group 2), but it was not significant and was not maintained during the 6 month post treatment period of routine therapy. This was also true in groups (3) and (4); neither the therapists alone setting the aims or doing it collaboratively with the caregiver significantly influenced outcome. Also, both the children and therapists complained about the 6 months of intensive therapy being “stressful and tiring”.
This well done study explored a difficult area evaluating both the usefulness of intensive therapy and of family participation in goal setting. It also demonstrated that programs of physiotherapy can be evaluated utilizing modern methods of clinical trial investigation. Using similar formats, other questions can–and should–be addressed. The results of the above study, are disappointing, but an exploration of the positive trends might reveal the characteristics of that group who might benefit from these interventions and who should be further studied.
Also, we need to consider whether any intervention improves performance by raising the subject permanently to an improved level of performance or by improving performance within the limits of the present range of abilities. Many interventions have been shown to provide some improvement of function for short periods of time; however, when evaluated in one to two years, there appears to have been no meaningful permanent improvement that can be attributed to the intervention. We also know that the participation in a trial itself is a strong stimulus for temporary improvement, irrespective of the nature of the intervention. Thus, follow-up over time is an essential ingredient of evaluating the efficacy of an intervention.
In any case, this study explored two aspects of the strategies of physical therapy and found each to be ineffective for long-term improvement in the populations studied.
1/ Bower E, et al. Randomized controlled clinical trial of physiotherapy in 56 children with cerebral palsy followed for 18 months. DMCN 2001; 43: 4-15