Hôpital San Salvadour
Hyères, Var, 83407, France
Location status: Recruiting
NCT Number: NCT04280458
Primary objective of the study is to compare and evaluate the impact of intensive care of rehabilitation of psychomotor vs. the standard care on adaptive behaviour of children with polyhandicap at 12 months after randomization.
Interested in participating?
Request Info4 year–13 year
All sexes
Interventional
Not applicable
Hyères, Var, 83407, France
Location status: Recruiting
As secondary objectives, the study aims to:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intervention included:
during 12 months.
Intervention included:
Time frame: At 12 months
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
Time frame: At 6 months
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
Time frame: At 12 months
Brunet-Lézine Scale will be used to evaluate the evolution of development.
Time frame: At 12 months
Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain.
Time frame: at 18 months
Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities.
Time frame: at 18 months
The Brunet-Lézine scale for the cognitive and motor assessment will be used to evaluate durability of acquired cognitive-motor abilities.
Time frame: At baseline and 12 months
WHOQOL-Bref questionnaire will be used.
Time frame: At baseline and 12 months
Hospital Anxiety and Depression Scale will be used to evaluate the emotional distress of polyhandicapped children's parents.
Time frame: At baseline and 12 months
Caregiver Reaction Assessment (CRA) will be used to evaluate the specific burden of polyhandicapped children's parents.
Time frame: At baseline and 12 months
Clinical Global Impressions (CGI) Scale will be used by caregivers.
Time frame: At baseline and 12 months
The tool as Professional Quality of Life ProQOL will be used to measure quality of life of caregivers.
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap
Acronym: REEDUC-PLH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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