CP (Cerebral Palsy)Phase 3Dual-TaskNCT01799304
Static and Dynamic Postural Stability in Cerebral Palsy Children
A Phase 3 study testing visual and sound attentional distractors, sound attentional distractor alone and additional cognitive task in people with CP (Cerebral Palsy) and Diplegia, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- CP (Cerebral Palsy), Diplegia, Hemiplegia
- What is being tested?
- visual and sound attentional distractors, sound attentional distractor alone and additional cognitive task
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is it Possible to Improve Static and Dynamic Postural Stability in Cerebral Palsy Children by Modulating Attention?
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 :
Read more
- 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.
Read the 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.
- Conditions
- CP (Cerebral Palsy), Diplegia, Hemiplegia, Postural; Defect
- Being tested
- no distractor control group, visual and sound attentional distractors, sound attentional distractor alone, additional cognitive task
- Keywords
- Locomotion, cerebral palsy, Postural; Defect
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no distractor control groupProcedure or surgery
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 distractorsProcedure or surgery
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 aloneProcedure or surgery
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 taskProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| no distractor control group | Experimental | postural control and locomotion of CP children without attentional distractor and without additional cognitive task (control condition) Receives: 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). Receives: 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). Receives: 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) Receives: Procedure: additional cognitive task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First day of inclusion T0
Secondary outcomes (4)
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)
Measured: First day of inclusion T0
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)
Measured: First day of inclusion T0
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)
Measured: First day of inclusion T0
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)
Measured: First day of inclusion T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for CP (Cerebral Palsy)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Christine COMMARE, MD, Principal investigator, Unité de MPR Pédiatrique, CHU GRENOBLEVincent NOUGIER, Pr, Principal investigator, Laboratoire TIMC-IMAG, Faculté de MédecineDominic PÉRENNOU, Pr, Principal investigator, Clinique MPR- Institut de Rééducation- Hôpital sud, CHU GrenobleIsabelle OLIVIER, Pr, Principal investigator, Laboratoire TIMC-IMAG, Faculté de MédecineBARBIERI GUILLAUME, Study chair, Laboratoire TIMC-IMAG, Faculté de MédecineFARIGOULE VINCENT, MD, Principal investigator, University Hospital, GrenoblePRADO CHLOE, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799304
- Sponsor's protocol ID
- DCIC - 13 01
- Acronym
- Dual-Task
- Status last verified
- Mar 2016
- First submitted
- 14 Feb 2013
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 6480437Berger 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.
PubMed 9595572Blanchard 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.
PubMed 16357673Brogren 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.
PubMed 9595574Burtner 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.
PubMed 10200406Cherng 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.
PubMed 10418839Christ SE, White DA, Brunstrom JE, Abrams RA. Inhibitory control following perinatal brain injury. Neuropsychology. 2003 Jan;17(1):171-8.
PubMed 12597086Crenna 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.
PubMed 9595571Heinen 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.
PubMed 19914110Holt 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.
PubMed 10630284Lajoie 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.
PubMed 8131825
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Possible to Improve Static and Dynamic Postural Stability in Cerebral Palsy Children by Modulating Attention?
- ClinicalTrials.gov ID
- NCT01799304
- Acronym / sponsor ID
- Dual-Task / DCIC - 13 01
- Conditions
- CP (Cerebral Palsy), Diplegia, Hemiplegia, Postural; Defect
- Keywords
- Locomotion, cerebral palsy, Postural; Defect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| no distractor control group | Experimental | Procedure: no distractor control grouppostural control and locomotion of CP children without attentional distractor and without additional cognitive task (control condition) |
| visual and sound attentional distractors | Experimental | Procedure: visual and sound attentional distractorspostural control and locomotion of CP children with visual and sound attentional distractors (video film). |
| sound attentional distractor alone | Experimental | Procedure: sound attentional distractor alonepostural control and locomotion of CP children with sound attentional distractor alone (sound track of the video film). |
| additional cognitive task | Experimental | Procedure: additional cognitive taskpostural control and locomotion of CP children with an additional cognitive task (adapted Stroop task with animals) |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no distractor control groupThis 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. | Procedure or surgery | no distractor control group |
| visual and sound attentional distractorsThe 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. | Procedure or surgery | visual and sound attentional distractors |
| sound attentional distractor aloneIn 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. | Procedure or surgery | sound attentional distractor alone |
| additional cognitive taskThe 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) | Procedure or surgery | additional cognitive task |
Primary outcome
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
Mean velocity of center of foot pressure displacements (mm/sec) in static posture under the different experimental conditions
4 secondary outcomes
Without attentional distractor and without additional cognitive task (control condition)
Time frame: First day of inclusion T0
With visual and sound attentional distractors (video film).
Time frame: First day of inclusion T0
With sound attentional distractor alone (sound track of the video film).
Time frame: First day of inclusion T0
With an additional cognitive task (adapted Stroop task with animals).
Time frame: First day of inclusion T0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- BackgroundAgostini, 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
- BackgroundAlbaret, JM., Benesteau, J., & Marquet-Doleac J. 1999. AI Test d'appariement d'images. Éditions ECPA
- Background: PubMed 6480437Berger W, Altenmueller E, Dietz V. Normal and impaired development of children's gait. Hum Neurobiol. 1984;3(3):163-70.
- Background: PubMed 9595572Berger 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.
- Background: PubMed 16357673Blanchard 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.
- Background: PubMed 9595574Brogren 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.
- Background: PubMed 10200406Burtner 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.
- Background: PubMed 10418839Cherng 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.
- Background: PubMed 12597086Christ SE, White DA, Brunstrom JE, Abrams RA. Inhibitory control following perinatal brain injury. Neuropsychology. 2003 Jan;17(1):171-8.
- BackgroundCrenna 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.
- BackgroundCrenna 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.
- Background: PubMed 9595571Crenna 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Christine COMMARE, MD principal investigator
Unité de MPR Pédiatrique, CHU GRENOBLE
Vincent NOUGIER, Pr principal investigator
Laboratoire TIMC-IMAG, Faculté de Médecine
Dominic PÉRENNOU, Pr principal investigator
Clinique MPR- Institut de Rééducation- Hôpital sud, CHU Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing visual and sound attentional distractors, sound attentional distractor alone and additional cognitive task in people with CP (Cerebral Palsy) and Diplegia, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01799304, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016; AzTrials last refreshed its copy on 30 Oct 2026.