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175 active trials for Cerebral Palsy

Effectiveness of Robotic Gait Training and Physical Therapy for Children and Youth With Cerebral Palsy

Robot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to support its effectiveness compared to best practice physical therapy is lacking. This research consists of a randomized controlled trial (RCT) and a qualitative descriptive study that is linked with the RCT. The goal of the RCT is to compare: 1) a walking training program with the Lokomat® robotic device (LOK), 2) a functional physical therapy program (fPT) that includes activities to enhance balance/co-ordination/endurance and advanced motor skills conducted over 'real ground', 3) a combined Lokomat® + functional physical therapy (LOK+fPT) program, and 4) a regular maintenance therapy condition (CONT) for ambulatory children and youth with CP (aged 5- 18 years). The three intervention programs will consist of sixteen 50-minute sessions given twice weekly over 8 to 10 weeks. The primary objective of the RCT is to compare the four groups with respect to walking-related motor skills as measured by the Gross Motor Function Measure. The secondary objectives are to compare each intervention's impact on walking abilities, individualized goals, fitness, balance, physical activity levels, child's belief in ability to do physical activity, participation and quality of life. The investigators will also evaluate the extent of carryover or progress 3 months after the intervention. The qualitative part of the study will consist of interviews of children and parents after they have finished the study intervention. The information from the interviews will assist us with interpretation of the outcome results (areas of impact and amount of change) from the RCT. In particular, the interviews will 1) provide insight into their experiences with the trial interventions, 2) identify the mobility-related outcomes that are important to families and the factors that influence their preferences, and 3) explain the family values, experiences and contextual factors that influenced participation in the study. This research will provide information needed to allow clinicians and families to make informed choices about Lokomat therapy and physical therapy options in relation to their child's functional goals and abilities.

Start: January 2016
Trends in Prevalence and Comorbidities of Children With Cerebral Palsy in Norway

Many studies have reported that the prevalence of cerebral palsy (CP) has been relatively stable and is mainly due to events before birth and therefore cannot be prevented. However, these studies were undertaken in populations born towards the end of the last century. There has since been significant improvement in both obstetrical and neonatal intensive care. The main aim is to investigate trends in the prevalence and clinical characteristics of children with CP in Norway born from 1996 to 2010 in order to gain a modern understanding of the panorama of CP in Norway. The investigators suspect that improved methods of obstetrical and neonatal care introduced in Norway during the last 20 years has resulted in a decrease in the prevalence of CP as well as in the proportion of children with severe CP subtypes and comorbidities. The long term aim is to improve the quality of pregnancy care and newborn medicine for children at risk of CP, and to ensure equal diagnostics and treatment of patients with CP, regardless of place of residence in Norway. For this project, the investigators will use data from three national health registers: The Cerebral Palsy Registry of Norway (CPRN), The Medical Birth Registry of Norway and The Norwegian Patient Registry (NPR). The use of data from these high quality health registries provides us with a unique opportunity to study our aims on a population level, as well as per health region/health trust.

Start: January 2017
Evaluation of the Efficacy of the Injection of Botulinum Toxin A vs Scopolamine Patches in the Treatment of Drooling in Children With Cerebral Palsy

Cerebral palsy is the first cause of motor disability in developed countries. It is associated with altered motor function but also with mental, sensorial and behavior deficiencies. Drooling frequently occurs in children with cerebral palsy (37 to 58%). It causes multiple medical and social complications which can all increase disability and reduce quality of life for the patients and their family. Drooling treatments are various and includes orofacial rehabilitations, anticholinergic medications, botulinum toxin A and B salivary gland injections. Surgeries could also be used, but their benefits are often outweighed by the risk. Orofacial rehabilitation is firstly recommended, even if few studies evaluated its efficacy. Medication by Scopoderm®, a cutaneous anticholinergic drug, is frequently used in spite of frequent side effects and a lack of evidence regarding efficacy. Botulinum toxin salivary gland injections (Botox®) were shown to be effective in reducing the severity of drooling consequences for the patient quality of life up to 12 months after the injections (Reid 2008). A recent survey carried showed that treatment by Botox® injection would be preferred by professional to Scopoderm® patch, because of better tolerance and efficacy, even if Scopoderm® remained more used by professionals (Chaleat-Valayer 2016). However, a Cochrane review (Walshe 2012) concluded that there is 1) no strong consensus regarding assessment or the timing of all treatments 2) not enough efficacy studies with high level of evidence, 3) mostly efficacy studies vs placebo or no intervention 4) a lack of long term treatment assessment 5) a lack of studies on the patient quality of life. Our study will be a comparative randomized clinical trial with an active control arm. The hypothesis is that therapeutic treatment of drooling in children with cerebral palsy consisting of a standardized rehabilitation treatment associated with a botulinum toxin A injection (Botox®) in the salivary glands is more effective than the same rehabilitation treatment associated with a treatment by scopolamine patches (Scopoderm®). The main outcome will be assessed 15 months after initiation of treatment to evaluate long-term effectiveness. Patients from both arms of the trial will received rehabilitation, in order to compare treatment efficacy as it is done in real conditions of treatment. The efficacy of the treatment will be assessed on the impact of the drooling perceived by the patients and their family rather than on the measure of salivary production, as recommended (Walshe 2012).

Start: January 2019