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

Primary Purpose

CP (Cerebral Palsy), Diplegia, Hemiplegia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
no distractor control group
visual and sound attentional distractors
sound attentional distractor alone
additional cognitive task
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for CP (Cerebral Palsy) focused on measuring Locomotion, cerebral palsy, Postural; Defect

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chu Grenoble

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

no distractor control group

visual and sound attentional distractors

sound attentional distractor alone

additional cognitive task

Arm Description

postural control and locomotion of CP children without attentional distractor and without additional cognitive task (control condition)

postural control and locomotion of CP children with visual and sound attentional distractors (video film).

postural control and locomotion of CP children with sound attentional distractor alone (sound track of the video film).

postural control and locomotion of CP children with an additional cognitive task (adapted Stroop task with animals)

Outcomes

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.
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)
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).
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).
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).
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)

Full Information

First Posted
February 14, 2013
Last Updated
March 22, 2016
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01799304
Brief Title
Static and Dynamic Postural Stability in Cerebral Palsy Children
Acronym
Dual-Task
Official Title
Is it Possible to Improve Static and Dynamic Postural Stability in Cerebral Palsy Children by Modulating Attention?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 : neuromuscular functions sensory integration 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.
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: without attentional distractors and without additional cognitive task (control condition) with attentional visual and sound distractors (video film) with sound attentional distractor alone (sound track of the video film) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CP (Cerebral Palsy), Diplegia, Hemiplegia, Postural; Defect
Keywords
Locomotion, cerebral palsy, Postural; Defect

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no distractor control group
Arm Type
Experimental
Arm Description
postural control and locomotion of CP children without attentional distractor and without additional cognitive task (control condition)
Arm Title
visual and sound attentional distractors
Arm Type
Experimental
Arm Description
postural control and locomotion of CP children with visual and sound attentional distractors (video film).
Arm Title
sound attentional distractor alone
Arm Type
Experimental
Arm Description
postural control and locomotion of CP children with sound attentional distractor alone (sound track of the video film).
Arm Title
additional cognitive task
Arm Type
Experimental
Arm Description
postural control and locomotion of CP children with an additional cognitive task (adapted Stroop task with animals)
Intervention Type
Procedure
Intervention Name(s)
no distractor control group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
visual and sound attentional distractors
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
sound attentional distractor alone
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
additional cognitive task
Intervention Description
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)
Primary Outcome Measure Information:
Title
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.
Description
Mean velocity of center of foot pressure displacements (mm/sec) in static posture under the different experimental conditions
Time Frame
First day of inclusion T0
Secondary Outcome Measure Information:
Title
Without attentional distractor and without additional cognitive task (control condition)
Description
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)
Time Frame
First day of inclusion T0
Title
With visual and sound attentional distractors (video film).
Description
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)
Time Frame
First day of inclusion T0
Title
With sound attentional distractor alone (sound track of the video film).
Description
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)
Time Frame
First day of inclusion T0
Title
With an additional cognitive task (adapted Stroop task with animals).
Description
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)
Time Frame
First day of inclusion T0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Christine COMMARE, MD
Organizational Affiliation
Unité de MPR Pédiatrique, CHU GRENOBLE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent NOUGIER, Pr
Organizational Affiliation
Laboratoire TIMC-IMAG, Faculté de Médecine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominic PÉRENNOU, Pr
Organizational Affiliation
Clinique MPR- Institut de Rééducation- Hôpital sud, CHU Grenoble
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabelle OLIVIER, Pr
Organizational Affiliation
Laboratoire TIMC-IMAG, Faculté de Médecine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BARBIERI GUILLAUME
Organizational Affiliation
Laboratoire TIMC-IMAG, Faculté de Médecine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
FARIGOULE VINCENT, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PRADO CHLOE, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

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Static and Dynamic Postural Stability in Cerebral Palsy Children

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