Comment:

The UCP Research and Educational Foundation is often asked about the usefulness of a specific treatment for an impairment (e.g. muscle spasticity) or of a disability (e.g. difficulty walking) due to cerebral palsy. In many instances, the scientific answer is: “we don’t know!” This includes commonly used medical, surgical interventions (e.g. orthopedic surgery for toe walking) or other clinical interventions (e.g. hyperbaric oxygenation). Why don’t we know?

Over many years, clinicians using the commonly accepted medical, surgical and physiotherapy interventions have built up a body of experience that indicates when and how these treatments can be of help to persons with impairments and disabilities. Because these methods are so well established in clinical practice, it is difficult to evaluate them by establishing a scientifically sound clinical evaluation. There are methods to do this (e.g. comparing the results of one treatment to the results of another), but busy clinicians and hopeful parents are often reluctant to participate in the trial of an “accepted” intervention. Thus, these interventions continue to be used, altered over time by thoughtful clinicians and the experiences reported. However, the scientific proof for their usefulness has often not been demonstrated.

Another of the major problems in establishing an adequate clinical evaluation (trial) is the diversity of the characteristics of the population seeking treatment. Things that always need to be considered are: age; type and degree of impairment; type and degree of disability; associated factors (e.g. nutrition; breathing insufficiency; community resources) and criteria to evaluate “success”. Thus, large numbers of persons usually need to be involved in these evaluation efforts to account for differences in results that may be due to factors other than the treatment being evaluated.

In the case of newly proposed but still unsupported treatments (e.g. the Adeli Suit), all of the above problems are present; but also, the reluctance of clinicians and those with a disability to be involved in an “experiment” which may mean discontinuing the present type of treatment. Also, since unrecognized interventions are often not covered by insurance or other payment sources, the availability of funds to offset the clinical care costs are often not available. The research costs (special tests; record analysis) are generally available from government or non-government research organizations; but “clinical care costs” have to be provided from other sources. These trials, therefore, can be very expensive since the clinicians involved rarely are willing to donate their services and the facilities being used generally ask for full costs.

The desire to do scientifically acceptable clinical evaluation is universal. However, the planning, organization, conduct and financial support necessary are very difficult to put together.

Our Foundation provides the technical advice required to design these needed trials and the research funds needed to organize and do pilot studies. Unfortunately, applicants are very rare. Clinicians in academic institutions (e.g. university-affiliated hospitals and clinics) are more likely to want to evaluate clinical practices and have the needed evaluation services available to them. However, the cost of clinical trials is still a major problem. Other clinicians are busy doing what they have been taught to do and find it difficult to challenge what they believe to be true. It will probably take a great deal of public pressure — and cooperation — to change the situation so that evaluations of both accepted and unsupported clinical methods can be done.