CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 24 enrolled
Drug / intervention
no distractor control group +3 moreprocedure
Likely dose
Not stated in record
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Search/NCT01799304
NCT01799304Phase 3Completed

Is it Possible to Improve Static and Dynamic Postural Stability in Cerebral Palsy Children by Modulating Attention?

University Hospital, Grenoble·interventional·Posted Feb 26, 2013·Updated Mar 23, 2016

In Brief

A Phase 3 clinical trial evaluating no distractor control group, visual and sound attentional distractors, and 2 other interventions for CP (Cerebral Palsy) and 3 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Cerebral palsy (CP) concerns 2 children out of 1000 in the general population (SCPE 2002). It is the main cause of postural and motor deficits in children. During the past 20 years, the postural deficits exhibited by these children have been attributed to various factors : 1. neuromuscular functions 2. sensory integration 3. muscular-squeletic functions. The common point of all these studies is the existence of immature motor patterns, probably related to an inability to implement more elaborated and adapted motor patterns with respect the task to perform. CP children do not develop the characteristics of the plant grad locomotion. They exhibit a uniform muscular activation with a high level of co-activation. Locomotion is generally characterized by an increase of stretching reflexes at short latencies and by a low level of activation associated to a low modulation of gastrocnemius muscles.. These data also suggest that it is the control of the temporal rather than the spatial parameters of the head which are mainly altered in CP children. Even though static postural control and locomotion are considered as automatic processes, this control requires, however, a significant amount of attentional resources. Within this context, the amount of attentional resources which need to be solicited can provide information on two complementary dimensions. On one hand, on the level of automaticity of postural control and/or locomotion when subjects' attention is oriented toward another task. On the other hand, on the cognitive cost of postural control and/or locomotion, depending on children age, that is, as a function of their level of maturation and of the nature and importance of their sensory-motor deficits. When the amount of required attentional resources is reduced, postural control and/or locomotion is considered as automatic processes with a low cognitive cost. The dual task paradigm in which subjects have to simultaneously process a cognitive (e.g. Stroop task) and a postural or motor task (e.g., standing upright on a force platform) is generally used to investigate these questions. How an appropriate allocation of attention is performed as a function of the cognitive and postural/motor tasks is important in the developmental process of posture and locomotion. It seems to be even more crucial in CP children and more generally in pathology. The main goal of the present project is to investigate the contribution of attentional processes in postural control and locomotion of CP children as compared to control healthy children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 26, 2013
Enrollment StartFeb 1, 2013
Primary CompletionMar 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.3 years ago

Interventions

no distractor control groupprocedure

This control condition will aim at analyzing posture and locomotion in CP children with the intent to focus attention on their equilibrium, only, without any other interference.

visual and sound attentional distractorsprocedure

The distractors will be used to orient subjects' attention toward another simple and motivating task in order to avoid focalisation on postural control and locomotion and to favour a more automatic control.

sound attentional distractor aloneprocedure

In addition to the previous condition, the goal of the present condition is to isolate the effects of a sound distractor, since it is known that CP children frequently exhibit visual deficits which may affect their postural and locomotion difficulties.

additional cognitive taskprocedure

The additional cognitive task aimed to increase the attentional load and to analyse its impact on children's capacity to process two tasks simultaneously (the cognitive and postural or locomotor tasks)