Static and Dynamic Postural Stability in Cerebral Palsy Children

NCT01799304 | Completed Phase 3

• 1 other identifier: DCIC - 13 01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 :

1. 1.neuromuscular functions
2. 2.sensory integration
3. 3.muscular-squeletic functions.

Conditions

CP (Cerebral Palsy); Diplegia; Hemiplegia; Postural; Defect

Keywords

Locomotion; cerebral palsy; Postural; Defect

Outcome Measures

Primary Outcomes (1)

• 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

  First day of inclusion T0

Secondary Outcomes (4)

• Without attentional distractor and without additional cognitive task (control condition)

  First day of inclusion T0

• With visual and sound attentional distractors (video film).

  First day of inclusion T0

• With sound attentional distractor alone (sound track of the video film).

  First day of inclusion T0

• With an additional cognitive task (adapted Stroop task with animals).

  First day of inclusion T0

Study Arms (4)

no distractor control group

EXPERIMENTAL

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

Procedure: no distractor control group

visual and sound attentional distractors

EXPERIMENTAL

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

Procedure: visual and sound attentional distractors

sound attentional distractor alone

EXPERIMENTAL

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

Procedure: sound attentional distractor alone

additional cognitive task

EXPERIMENTAL

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

Procedure: additional cognitive task

Interventions

no distractor control group PROCEDURE

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.

no distractor control group

visual and sound attentional distractors PROCEDURE

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.

visual and sound attentional distractors

sound attentional distractor alone PROCEDURE

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.

sound attentional distractor alone

additional cognitive task PROCEDURE

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)

additional cognitive task

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Chu Grenoble

Grenoble, 38000, France

Location

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  BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• BARBIERI GUILLAUME

  Laboratoire TIMC-IMAG, Faculté de Médecine

  STUDY CHAIR

• FARIGOULE VINCENT, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• PRADO CHLOE, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 26, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

FR (1)