Static and Dynamic Postural Stability in Cerebral Palsy Children (Dual-Task)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01799304
First received: February 14, 2013
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
CP (Cerebral Palsy)
Diplegia
Hemiplegia
Postural; Defect
Procedure: no distractor control group
Procedure: visual and sound attentional distractors
Procedure: sound attentional distractor alone
Procedure: additional cognitive task
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Is it Possible to Improve Static and Dynamic Postural Stability in Cerebral Palsy Children by Modulating Attention?

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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. [ Time Frame: First day of inclusion T0 ] [ Designated as safety issue: No ]
    Mean velocity of center of foot pressure displacements (mm/sec) in static posture under the different experimental conditions


Secondary Outcome Measures:
  • Without attentional distractor and without additional cognitive task (control condition) [ Time Frame: First day of inclusion T0 ] [ Designated as safety issue: No ]

    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.

    Outcome measurement : Mean velocity of center of foot pressure displacements (mm/sec)


  • With visual and sound attentional distractors (video film). [ Time Frame: First day of inclusion T0 ] [ Designated as safety issue: No ]

    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.

    Outcome measurement : Mean velocity of center of foot pressure displacements (mm/sec)


  • With sound attentional distractor alone (sound track of the video film). [ Time Frame: First day of inclusion T0 ] [ Designated as safety issue: No ]

    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.

    Outcome measurement : Mean velocity of center of foot pressure displacements (mm/sec)


  • With an additional cognitive task (adapted Stroop task with animals). [ Time Frame: First day of inclusion T0 ] [ Designated as safety issue: No ]
    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) Outcome measurement : Mean velocity of center of foot pressure displacements (mm/sec)


Estimated Enrollment: 24
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: no distractor control group
postural control and locomotion of CP children without attentional distractor and without additional cognitive task (control condition)
Procedure: no distractor control group
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.
Experimental: visual and sound attentional distractors
postural control and locomotion of CP children with visual and sound attentional distractors (video film).
Procedure: visual and sound attentional distractors
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.
Experimental: sound attentional distractor alone
postural control and locomotion of CP children with sound attentional distractor alone (sound track of the video film).
Procedure: sound attentional distractor alone
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.
Experimental: additional cognitive task
postural control and locomotion of CP children with an additional cognitive task (adapted Stroop task with animals)
Procedure: additional cognitive task
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)

Detailed Description:

Within this scientific and clinical context, we hypothesize:

  • That CP children will be less stable than healthy children (in control situation) and that the attentional cost for controlling static posture will be higher.
  • On the basis of Olivier et al.'s work (2008) showing in adults and children aged 4 to 11 that postural control is better when attention is oriented toward a video film (i.e., decrease of the attentional demand allocated to the control of static posture), we predict that CP children will be more stable in dual task situation with visual or sound distractors than when focusing attention on postural control alone.
  • We also predict that an additional cognitive task (adapted Stroop task), by increasing the attentional demand, will induce a deficit of postural control confirming Reilly et al.'s results (2008b).

On the same basis, we will also investigate the attentional cost of locomotion.

Exploratory study of dynamic equilibrium during locomotion in the same conditions.

Investigation of posture in the following conditions:

  1. without attentional distractors and without additional cognitive task (control condition)
  2. with attentional visual and sound distractors (video film)
  3. with sound attentional distractor alone (sound track of the video film)
  4. with an additional cognitive task (Stroop task adapted for children).

Considering the goals of this research project, no serious undesirable event is expected to occur. However, falls may occur accidentally while rising or descending from the force platform, during static posture, or during locomotion. Consequently, in addition to the experimenter, a physiotherapist or someone of the medical staff will be present during all experimental recordings.

The environment will be also organized to the secure the experimental room by excluding all potentials dangerous or non necessary objects. Whenever necessary, the potentials falls will be reported and declared to the health authorities.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CP children with postural and/or motor deficits due to early cerebral deficits (from conception to 2 years of age according to G. Tardieu) non hereditary and non evolutionary.
  • Aged 7 to 12 years because before 7 years of age the range and speed of postural control exhibit a great variability and after 12, our eligibility criteria are not standardized
  • presenting a clinical CP diplegia or hemiplegia (cf. EMGF),
  • able to stand upright without assistance for at least (real recording time of 30 sec during the experiment) on a force platform (L 50 cm x l 50 cm x h 4,4 cm) and to walk straight ahead on a walking track (518 cm long x 90 cm wide and 0,5 cm thin) without assistance,
  • without severe visual or hearing deficit (>0,3 for the worse eye without correction or hearing loss <70db for the worse ear without correction) as indicated in the personal medical report
  • without hyperactivity trouble (Conners' questionnaires non significant <70), without major attentional deficits (images matching test), without denomination troubles (ELOLA test), able to perform dual tasks (Tea-ch test).

Exclusion Criteria:

  • parents' or children' informed consent rejected,
  • Participation to another biomedical experiment during this study,
  • Children unable to control upright posture without assistance for at least 45 sec on a force platform (L 50 cm x l 50 cm x h 4.4 cm) or unable to walk without assistance
  • Absence of social security coverage.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799304

Contacts
Contact: carole ROLLAND 04 76 76 50 40 CarRolland@chu-grenoble.fr

Locations
France
Chu Grenoble Recruiting
Grenoble, France, 38000
Principal Investigator: OLIVIER ISABELLE, MD         
Principal Investigator: NOUGIER VINCENT, MD         
Principal Investigator: PERENNOU DOMINIC, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Marie-Christine COMMARE, MD Unité de MPR Pédiatrique, CHU GRENOBLE
Principal Investigator: Vincent NOUGIER, Pr Laboratoire TIMC-IMAG, Faculté de Médecine
Principal Investigator: Dominic PÉRENNOU, Pr Clinique MPR- Institut de Rééducation- Hôpital sud, CHU Grenoble
Principal Investigator: Isabelle OLIVIER, Pr Laboratoire TIMC-IMAG, Faculté de Médecine
Study Chair: BARBIERI GUILLAUME Laboratoire TIMC-IMAG, Faculté de Médecine
Principal Investigator: FARIGOULE VINCENT, MD CHU GRENOBLE
Principal Investigator: PRADO CHLOE, MD CHU GRENOBLE
  More Information

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01799304     History of Changes
Other Study ID Numbers: DCIC - 13 01
Study First Received: February 14, 2013
Last Updated: April 15, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: French Data Protection Authority

Keywords provided by University Hospital, Grenoble:
Locomotion
cerebral palsy
Postural; Defect

Additional relevant MeSH terms:
Cerebral Palsy
Hemiplegia
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014