PolyhandicapREEDUC-PLHNCT04280458
Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap
A study testing Intentive rehabilitation and Routine care in people with Polyhandicap, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Polyhandicap
- What is being tested?
- Intentive rehabilitation and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2022to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 4 and 13 years;
- With polyhandicap defined by association of the 5 following criteria:
- 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
- Score of Gross Motor Function Classification System [Palisano 1997] is III, IV or V
Show all 10Show fewer
- Score of Functional Independence Measure < 50;
- Hospitalization in a clinical setting participating to the study;
- Beneficiary of a social protection;
- Written consent signed by personnel holding parental authority or legal representative.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital San Salvadour
Hyères, Var, 83407
Marie-Christine ROUSSEAU, MD, + 33 6 70 90 30 90, marie-christine.rousseau@aphp.fr
About this study
Official title: Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap
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.
Read the detailed description
As secondary objectives, the study aims to:
- compare and evaluate the impact of this intensive care of rehabilitation of psychomotor vs. the standard care on:
- result of evaluation with Vineland Scale of adaptive behaviour at 6 months after randomization;
- result of evaluation with Brunet-Lézine Scale of developement at 12 months after randomization;
- the pain evaluation at 12 months after randomization;
- the durability of acquired cognitive-motor improvement at 6 months after the end of intervention (18 months after randomization);
- the quality of life of the patients' family or relatives at 12 months after randomization;
- the clinical global impressions and the quality of life for work for the long-term professional caregivers at 12 months after randomization.
- evaluate the tolerance of intensive care in psychomotor rehabilitation at 6 and 12 months after randomization.
- study the concordance between the Vineland scale and the Brunet-Lézine scale.
- Conditions
- Polyhandicap
- Being tested
- Intentive rehabilitation, Routine care
- Keywords
- children polyhandicap, rehabilitation, psychomotor, cognitive-motor, adaptative skill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intentive rehabilitationBehavioural
Intervention included:
- psychomotor 5 hours/week ±30 minutes
- kinesitherapy 1.5 hour/week ±20 minutes during 12 months.
Routine careBehavioural
Intervention included:
- kinesitherapy 0.5 hour/week ±10 minutes
- psychomotor 30 min/week ±10 minutes during 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | patients will receive intensive care of rehabilitation of psychomotor Receives: Behavioral: Intentive rehabilitation |
| Control group | Active comparator | patients will receive standard care Receives: Behavioral: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of adaptative behaviour
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
Measured: At 12 months
Secondary outcomes (10)
Evolution of adaptative behaviour
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
Measured: At 6 months
Evolution of development
Brunet-Lézine Scale will be used to evaluate the evolution of development.
Measured: At 12 months
Pain evaluation
Scale named Echelle Douleur Enfant San Salvadour (EDESS, in French language) will be used to evaluate the pain.
Measured: At 12 months
Durability of acquired cognitive-motor abilities
Vineland Adaptativ Behavior Scales will be used to evaluate durability of acquired cognitive-motor abilities.
Measured: at 18 months
Durability of acquired cognitive-motor abilities
The Brunet-Lézine scale for the cognitive and motor assessment will be used to evaluate durability of acquired cognitive-motor abilities.
Measured: at 18 months
Quality of family's life surveys
WHOQOL-Bref questionnaire will be used.
Measured: At baseline and 12 months
Emotional distress measurement
Hospital Anxiety and Depression Scale will be used to evaluate the emotional distress of polyhandicapped children's parents.
Measured: At baseline and 12 months
Burden surveys
Caregiver Reaction Assessment (CRA) will be used to evaluate the specific burden of polyhandicapped children's parents.
Measured: At baseline and 12 months
Clinical Global Impressions by caregivers
Clinical Global Impressions (CGI) Scale will be used by caregivers.
Measured: At baseline and 12 months
Quality of caregivers' life
The tool as Professional Quality of Life ProQOL will be used to measure quality of life of caregivers.
Measured: At baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start20 Jun 2022
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PolyhandicapStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Christine ROUSSEAU, MD, Principal investigator, Polyhandicap adultes San Salvadour, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280458
- Sponsor's protocol ID
- APHP200866
- Other IDs
- 2020-A00800-39
- Acronym
- REEDUC-PLH
- Status last verified
- Mar 2025
- First submitted
- 17 Feb 2020
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Collignon P, Giusiano B. Validation of a pain evaluation scale for patients with severe cerebral palsy. Eur J Pain. 2001;5(4):433-42. doi: 10.1053/eujp.2001.0265.
PubMed 11743709Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
PubMed 20526405Laor-Maayany R, Goldzweig G, Hasson-Ohayon I, Bar-Sela G, Engler-Gross A, Braun M. Compassion fatigue among oncologists: the role of grief, sense of failure, and exposure to suffering and death. Support Care Cancer. 2020 Apr;28(4):2025-2031. doi: 10.1007/s00520-019-05009-3. Epub 2019 Aug 8.
PubMed 31392551
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intensive Psychomotor Rehabilitation on Cognitive-motor Abilities and Adaptive Capacity of Children With Polyhandicap
- ClinicalTrials.gov ID
- NCT04280458
- Acronym / sponsor ID
- REEDUC-PLH / APHP200866
- Conditions
- Polyhandicap
- Keywords
- children polyhandicap, rehabilitation, psychomotor, cognitive-motor, adaptative skill
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Feb 2020 (actual)
- 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.
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.
Detailed description
As secondary objectives, the study aims to:
- compare and evaluate the impact of this intensive care of rehabilitation of psychomotor vs. the standard care on:
- result of evaluation with Vineland Scale of adaptive behaviour at 6 months after randomization;
- result of evaluation with Brunet-Lézine Scale of developement at 12 months after randomization;
- the pain evaluation at 12 months after randomization;
- the durability of acquired cognitive-motor improvement at 6 months after the end of intervention (18 months after randomization);
- the quality of life of the patients' family or relatives at 12 months after randomization;
- the clinical global impressions and the quality of life for work for the long-term professional caregivers at 12 months after randomization.
- evaluate the tolerance of intensive care in psychomotor rehabilitation at 6 and 12 months after randomization.
- study the concordance between the Vineland scale and the Brunet-Lézine scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intentive rehabilitationpatients will receive intensive care of rehabilitation of psychomotor |
| Control group | Active comparator | Behavioral: Routine carepatients will receive standard care |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Children between 4 and 13 years;
- With polyhandicap defined by association of the 5 following criteria:
- Hospitalization in a clinical setting participating to the study;
- Beneficiary of a social protection;
- Written consent signed by personnel holding parental authority or legal representative.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Intentive rehabilitationIntervention included: * psychomotor 5 hours/week ±30 minutes * kinesitherapy 1.5 hour/week ±20 minutes during 12 months. | Behavioural | Intervention group |
| Routine careIntervention included: * kinesitherapy 0.5 hour/week ±10 minutes * psychomotor 30 min/week ±10 minutes during 12 months. | Behavioural | Control group |
Primary outcome
Evolution of adaptative behaviour
Time frame: At 12 months
Vineland II Scale will be used to evaluate the evolution of adaptative behaviour.
10 secondary outcomes
Evolution of adaptative behaviour
Time frame: At 6 months
Evolution of development
Time frame: At 12 months
Pain evaluation
Time frame: At 12 months
Durability of acquired cognitive-motor abilities
Time frame: at 18 months
Durability of acquired cognitive-motor abilities
Time frame: at 18 months
Quality of family's life surveys
Time frame: At baseline and 12 months
Emotional distress measurement
Time frame: At baseline and 12 months
Burden surveys
Time frame: At baseline and 12 months
Clinical Global Impressions by caregivers
Time frame: At baseline and 12 months
Quality of caregivers' life
Time frame: At baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 11743709Collignon P, Giusiano B. Validation of a pain evaluation scale for patients with severe cerebral palsy. Eur J Pain. 2001;5(4):433-42. doi: 10.1053/eujp.2001.0265.
- Background: PubMed 20526405Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
- Background: PubMed 31392551Laor-Maayany R, Goldzweig G, Hasson-Ohayon I, Bar-Sela G, Engler-Gross A, Braun M. Compassion fatigue among oncologists: the role of grief, sense of failure, and exposure to suffering and death. Support Care Cancer. 2020 Apr;28(4):2025-2031. doi: 10.1007/s00520-019-05009-3. Epub 2019 Aug 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.
Marie-Christine ROUSSEAU, MD principal investigator
Polyhandicap adultes San Salvadour, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intentive rehabilitation and Routine care in people with Polyhandicap, run by Assistance Publique - Hôpitaux de Paris 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 10 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Christine ROUSSEAU, MD (+33 (4) 94 38 08 17, marie-Christine.rousseau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of adaptative behaviour (time frame: At 12 months). 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 NCT04280458, which also lists 3 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 19 Mar 2025.