Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap

ConditionPolyhandicap
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-13
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children between 4 and 13 years;

Causal brain injury occurred before the age of 3 years

Severe or deep mental deficiency as defined by IQ < 40, or no evaluable by the psychometric tests

Motor impairment: para / tetraparesis, hemiparesis, ataxia, or extrapyramidal motor disorders

Disqualifiers

Patient with progressive encephalopathies including metabolic origin, epileptic, or neurodegenerative diseases;

Planned to move in another clinical setting;

Foreseeable difficulty in the following up in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intentive rehabilitation

    Behavioral

    Intervention included: * psychomotor 5 hours/week ±30 minutes * kinesitherapy 1.5 hour/week ±20 minutes during 12 months.

  • Routine care

    Behavioral

    Intervention included: * kinesitherapy 0.5 hour/week ±10 minutes * psychomotor 30 min/week ±10 minutes during 12 months.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Evolution of adaptative behaviour

Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.

Time frame
At 12 months

Secondary outcomes

1

Evolution of adaptative behaviour

Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.

Time frame
At 6 months
2

Evolution of development

Brunet-Lézine Scale will be used to evaluate the evolution of development.

Time frame
At 12 months
3

Pain evaluation

Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain.

Time frame
At 12 months
4

Durability of acquired cognitive-motor abilities

Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities.

Time frame
at 18 months

Other outcomes

Sponsors and contacts

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