Static and Dynamic Postural Stability in Cerebral Palsy Children
NCT ID: NCT01799304
Last Updated: 2016-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
24 participants
INTERVENTIONAL
2013-02-28
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy
NCT04603625
Sitting Postural Control in Infants With Cerebral Palsy
NCT01200927
The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Spastic Diplegia Cerebral Palsy
NCT05198921
Upper Extremity Function In Cerebral Palsy And Its Association With Balance And Trunk Control
NCT03179124
Kinesio Taping in Sit to Stand Movement fo Cerebral Palsy
NCT03403322
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
no distractor control group
postural control and locomotion of CP children without attentional distractor and without additional cognitive task (control condition)
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.
visual and sound attentional distractors
postural control and locomotion of CP children with visual and sound attentional distractors (video film).
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.
sound attentional distractor alone
postural control and locomotion of CP children with sound attentional distractor alone (sound track of the video film).
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.
additional cognitive task
postural control and locomotion of CP children with an additional cognitive task (adapted Stroop task with animals)
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
7 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Grenoble
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marie-Christine COMMARE, MD
Role: PRINCIPAL_INVESTIGATOR
Unité de MPR Pédiatrique, CHU GRENOBLE
Vincent NOUGIER, Pr
Role: PRINCIPAL_INVESTIGATOR
Laboratoire TIMC-IMAG, Faculté de Médecine
Dominic PÉRENNOU, Pr
Role: PRINCIPAL_INVESTIGATOR
Clinique MPR- Institut de Rééducation- Hôpital sud, CHU Grenoble
Isabelle OLIVIER, Pr
Role: PRINCIPAL_INVESTIGATOR
Laboratoire TIMC-IMAG, Faculté de Médecine
BARBIERI GUILLAUME
Role: STUDY_CHAIR
Laboratoire TIMC-IMAG, Faculté de Médecine
FARIGOULE VINCENT, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
PRADO CHLOE, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chu Grenoble
Grenoble, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Agostini, M., Metz-Lutz , M.N., Van Hout, A., Chavance, M., Deloche, G., Pavao- Martins & Dellatolas. 1998. Batterie d'évaluation du langage oral de l'enfant aphasique - ELOLA. Revue de Neuropsychologie, 8, 319-367
Albaret, JM., Benesteau, J., & Marquet-Doleac J. 1999. AI Test d'appariement d'images. Éditions ECPA
Berger W, Altenmueller E, Dietz V. Normal and impaired development of children's gait. Hum Neurobiol. 1984;3(3):163-70.
Berger W. Characteristics of locomotor control in children with cerebral palsy. Neurosci Biobehav Rev. 1998 Jul;22(4):579-82. doi: 10.1016/s0149-7634(97)00047-x.
Blanchard Y, Carey S, Coffey J, Cohen A, Harris T, Michlik S, Pellecchia GL. The influence of concurrent cognitive tasks on postural sway in children. Pediatr Phys Ther. 2005 Fall;17(3):189-93. doi: 10.1097/01.pep.0000176578.57147.5d.
Brogren E, Hadders-Algra M, Forssberg H. Postural control in sitting children with cerebral palsy. Neurosci Biobehav Rev. 1998 Jul;22(4):591-6. doi: 10.1016/s0149-7634(97)00049-3.
Burtner PA, Qualls C, Woollacott MH. Muscle activation characteristics of stance balance control in children with spastic cerebral palsy. Gait Posture. 1998 Dec 1;8(3):163-174. doi: 10.1016/s0966-6362(98)00032-0.
Cherng RJ, Su FC, Chen JJ, Kuan TS. Performance of static standing balance in children with spastic diplegic cerebral palsy under altered sensory environments. Am J Phys Med Rehabil. 1999 Jul-Aug;78(4):336-43. doi: 10.1097/00002060-199907000-00008.
Christ SE, White DA, Brunstrom JE, Abrams RA. Inhibitory control following perinatal brain injury. Neuropsychology. 2003 Jan;17(1):171-8.
Crenna P, Inverno M, Frigo C, Palmieri R, Fedrizzi E. Pathophysiological profile of gait in children with cerebral palsy. In: Forssberg H, hirschfeld H, editors. Movement disorders in children. Karger: Medicine and Sport Sciences. Basel; 1992. p. 186-98.
Crenna P, Inverno M. Objective detection of pathophysiological factors contributing to gait disturbance. In motor development in children, E. Fedrizzi, G. Avanzini and P. Crenna. John Libbey (Eds) London;1994. p. 103-18.
Crenna P. Spasticity and 'spastic' gait in children with cerebral palsy. Neurosci Biobehav Rev. 1998 Jul;22(4):571-8. doi: 10.1016/s0149-7634(97)00046-8.
Heinen F, Desloovere K, Schroeder AS, Berweck S, Borggraefe I, van Campenhout A, Andersen GL, Aydin R, Becher JG, Bernert G, Caballero IM, Carr L, Valayer EC, Desiato MT, Fairhurst C, Filipetti P, Hassink RI, Hustedt U, Jozwiak M, Kocer SI, Kolanowski E, Krageloh-Mann I, Kutlay S, Maenpaa H, Mall V, McArthur P, Morel E, Papavassiliou A, Pascual-Pascual I, Pedersen SA, Plasschaert FS, van der Ploeg I, Remy-Neris O, Renders A, Di Rosa G, Steinlin M, Tedroff K, Valls JV, Viehweger E, Molenaers G. The updated European Consensus 2009 on the use of Botulinum toxin for children with cerebral palsy. Eur J Paediatr Neurol. 2010 Jan;14(1):45-66. doi: 10.1016/j.ejpn.2009.09.005. Epub 2009 Nov 14.
Holt KG, Ratcliffe R, Jeng SF. Head stability in walking in children with cerebral palsy and in children and adults without neurological impairment. Phys Ther. 1999 Dec;79(12):1153-62.
Lajoie Y, Teasdale N, Bard C, Fleury M. Attentional demands for static and dynamic equilibrium. Exp Brain Res. 1993;97(1):139-44. doi: 10.1007/BF00228824.
Laufer Y, Ashkenazi T, Josman N. The effects of a concurrent cognitive task on the postural control of young children with and without developmental coordination disorder. Gait Posture. 2008 Feb;27(2):347-51. doi: 10.1016/j.gaitpost.2007.04.013. Epub 2007 May 29.
Leonard C. Neural and behavioral changes associated with perinatal damage. In: H.Forssberg and H. Hirschfeld Eds. Movement Disorders in Children. Karger: Medicine and Sport Science Basel; 1992. p. 50-6.
Lowes LP, Westcott SL, Palisano RJ, Effgen SK, Orlin MN. Muscle force and range of motion as predictors of standing balance in children with cerebral palsy. Phys Occup Ther Pediatr. 2004;24(1-2):57-77. doi: 10.1300/j006v24n01_03.
Mainly T., Robertson IH, Anderson V., & Mimmo-Smith I. 2004. Test d'évaluation de l'attention chez l'enfant. Éditions ECPA
Molin I, Alricsson M. Physical activity and health among adolescents with cerebral palsy in Sweden. Int J Adolesc Med Health. 2009 Oct-Dec;21(4):623-33. doi: 10.1515/ijamh.2009.21.4.623.
Nashner LM, Shumway-Cook A, Marin O. Stance posture control in select groups of children with cerebral palsy: deficits in sensory organization and muscular coordination. Exp Brain Res. 1983;49(3):393-409. doi: 10.1007/BF00238781.
Okoshi Y, Itoh M, Takashima S. Characteristic neuropathology and plasticity in periventricular leukomalacia. Pediatr Neurol. 2001 Sep;25(3):221-6. doi: 10.1016/s0887-8994(01)00309-5.
Olivier I, Cuisinier R, Vaugoyeau M, Nougier V, Assaiante C. Dual-task study of cognitive and postural interference in 7-year-olds and adults. Neuroreport. 2007 May 28;18(8):817-21. doi: 10.1097/WNR.0b013e3280e129e1.
Olivier I, Cuisinier R, Vaugoyeau M, Nougier V, Assaiante C. Age-related differences in cognitive and postural dual-task performance. Gait Posture. 2010 Oct;32(4):494-9. doi: 10.1016/j.gaitpost.2010.07.008. Epub 2010 Aug 9.
Olivier I, Palluel E, Nougier V. Effects of attentional focus on postural sway in children and adults. Exp Brain Res. 2008 Feb;185(2):341-5. doi: 10.1007/s00221-008-1271-6. Epub 2008 Jan 24.
Palluel E, Nougier V, Olivier I. Postural control and attentional demand during adolescence. Brain Res. 2010 Oct 28;1358:151-9. doi: 10.1016/j.brainres.2010.08.051. Epub 2010 Aug 22.
Platt MJ, Cans C, Johnson A, Surman G, Topp M, Torrioli MG, Krageloh-Mann I. Trends in cerebral palsy among infants of very low birthweight (<1500 g) or born prematurely (<32 weeks) in 16 European centres: a database study. Lancet. 2007 Jan 6;369(9555):43-50. doi: 10.1016/S0140-6736(07)60030-0.
Reilly DS, van Donkelaar P, Saavedra S, Woollacott MH. Interaction between the development of postural control and the executive function of attention. J Mot Behav. 2008 Mar;40(2):90-102. doi: 10.3200/JMBR.40.2.90-102.
Reilly DS, Woollacott MH, van Donkelaar P, Saavedra S. The interaction between executive attention and postural control in dual-task conditions: children with cerebral palsy. Arch Phys Med Rehabil. 2008 May;89(5):834-42. doi: 10.1016/j.apmr.2007.10.023.
Seidman LJ, Valera EM, Makris N, Monuteaux MC, Boriel DL, Kelkar K, Kennedy DN, Caviness VS, Bush G, Aleardi M, Faraone SV, Biederman J. Dorsolateral prefrontal and anterior cingulate cortex volumetric abnormalities in adults with attention-deficit/hyperactivity disorder identified by magnetic resonance imaging. Biol Psychiatry. 2006 Nov 15;60(10):1071-80. doi: 10.1016/j.biopsych.2006.04.031. Epub 2006 Jul 28.
Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40.
Woollacott MH, Burtner P. Neural and musculoskeletal contributions to the development of stance balance control in typical children and in children with cerebral palsy. Acta Paediatr Suppl. 1996 Oct;416:58-62. doi: 10.1111/j.1651-2227.1996.tb14279.x.
Woollacott MH, Burtner P, Jensen J, Jasiewicz J, Roncesvalles N, Sveistrup H. Development of postural responses during standing in healthy children and children with spastic diplegia. Neurosci Biobehav Rev. 1998 Jul;22(4):583-9. doi: 10.1016/s0149-7634(97)00048-1.
Woollacott MH, Crenna P. Postural control in standing and walking in children with cerebral palsy. Chapter. In: Hadders-Algra M, Brogren Carlberg E, editors. Posture: a key issue in developmental disorders. London: Mac Keith Press; 2008.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DCIC - 13 01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.