Static and Dynamic Postural Stability in Cerebral Palsy Children

Hemiplegia Clinical Trial

— Dual-Task  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799304
• Other study ID #: DCIC - 13 01
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2013
• Last updated: March 22, 2016
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

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.
• 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)

Locations

Country	Name	City	State
France	Chu Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (34)

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. — View Citation

Berger W. Characteristics of locomotor control in children with cerebral palsy. Neurosci Biobehav Rev. 1998 Jul;22(4):579-82. Review. — View Citation

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. — View Citation

Brogren E, Hadders-Algra M, Forssberg H. Postural control in sitting children with cerebral palsy. Neurosci Biobehav Rev. 1998 Jul;22(4):591-6. Review. — View Citation

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. — View Citation

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. — View Citation

Christ SE, White DA, Brunstrom JE, Abrams RA. Inhibitory control following perinatal brain injury. Neuropsychology. 2003 Jan;17(1):171-8. — View Citation

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. Review. — View Citation

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, Krägeloh-Mann I, Kutlay S, Mäenpää 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. Review. — View Citation

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. — View Citation

Lajoie Y, Teasdale N, Bard C, Fleury M. Attentional demands for static and dynamic equilibrium. Exp Brain Res. 1993;97(1):139-44. — View Citation

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. Epub 2007 May 29. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Okoshi Y, Itoh M, Takashima S. Characteristic neuropathology and plasticity in periventricular leukomalacia. Pediatr Neurol. 2001 Sep;25(3):221-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Prevalence and characteristics of children with cerebral palsy in Europe. Dev Med Child Neurol. 2002 Sep;44(9):633-40. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jul 28. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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.

* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	First day of inclusion T0	No
Secondary	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)	First day of inclusion T0	No
Secondary	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)	First day of inclusion T0	No
Secondary	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)	First day of inclusion T0	No