Children With Cerebral PalsyNCT06320496
Evaluation of the Effect of a Physical Activity Recovery Stay
An observational study of Children With Cerebral Palsy and Children With Cancer, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est at 1 site in France.
Trial summary
A WHO study in 2020 revealed that 81% of adolescents (aged 11-17) do not respect the recommendation of one hour of moderate physical activity per day. In the context of disability, many factors impose limits on physical activity. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Children With Cerebral Palsy, Children With Cancer
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2022to Sep 2026
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The children taking part in the return-to-physical-activity program are referred to the Flavigny-sur-Moselle CMPRE for medical consultation due to a state of deconditioning to physical exertion concomitant with a pathological situation. The pathology most frequently encountered during this stay is cerebral palsy. However, the Flavigny CMPRE is accredited in a number of fields (orthopedics, burns, neurology, oncology), and the pathologies of the children referred to this stay are representative of these. These include children with scoliosis, obesity, Guillain-Barré syndrome, cystic fibrosis, Charcot's disease and cancer.
Who may be able to join
- Children with a pathology (chronic disease, rare disease or disability) in a state of deconditioning to exercise
- Taken in charge at the CMPRE for a stay to resume physical activity
Who cannot join
- Age under 8 and over 18
- Patients undergoing rehabilitation during the stay
- Patients with a significant change in their therapeutic management during the stay
- Significant cognitive impairment preventing comprehension of instructions
- Significant club or leisure sports activity (3x/week)
- Electric wheelchair
- Non-compliance with stay (5 ½ days missed out of total stay)
- Participation in another study during the return-to-physical-activity stay
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
Institut Régional de Médecine Physique et de Réadaptation
Nancy, 54000
Jonathan Pierret, PhD, +33 3 82 52 6761, jonathan.pierret@ugecam.assurance-maladie.fr
About this study
Official title: Evaluation of the Effect of a Physical Activity Recovery Stay on the Physical Condition and Quality of Life of Children in a Situation of Physical Deconditioning
A WHO study in 2020 revealed that 81% of adolescents (aged 11-17) do not respect the recommendation of one hour of moderate physical activity per day. In the context of disability, many factors impose limits on physical activity. While the pathology itself induces limitations and restrictions (prolonged sitting time, assisted movement, etc.), organizational constraints also apply to both children and parents, who have to divide their time between work, school and therapeutic care, which is sometimes numerous and varied over the course of a single week. These limitations generate stress and fatigue, and prolonged sedentary periods lead children with chronic illnesses, rare diseases or disabilities into a process of physical deconditioning. The accumulation of sedentary time is detrimental to cardiovascular and metabolic health.
To combat this deconditioning, the 2008 National Physical Activity and Sport Plan (PNAPS) sets out the main guidelines for treatment and implementation. The plan explains that "for patients with chronic illnesses, rare diseases or disabilities, the aim is to encourage care and guidance towards Adapted Physical Activity (APA). The attending physician will be able to identify local therapeutic education programs, rehabilitation services and "sport-santé" offers, to improve access for these patients to supervised local programs". In addition, the plan suggests "developing APA programs in healthcare establishments to enable people with chronic illnesses, rare diseases or disabilities to access health education incorporating practical sessions".
In line with this plan, an exercise reconditioning program has been set up at our facility. This three-month stay includes children with a variety of pathologies, but with a common feature of physical deconditioning.
- Conditions
- Children With Cerebral Palsy, Children With Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Deconditioning to physical exertion | The children taking part in the return-to-physical-activity program are referred to the Flavigny-sur-Moselle CMPRE for medical consultation due to a state of deconditioning to physical exertion concomitant with a pathological situation. The pathology most frequently encountered during this stay is cerebral palsy. However, the Flavigny CMPRE is accredited in a number of fields (orthopedics, burns, neurology, oncology), and the pathologies of the children referred to this stay are representative of these. These include children with scoliosis, obesity, Guillain-Barré syndrome, cystic fibrosis, Charcot's disease and cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnoform test score
To evaluate the effect of the return to physical activity stay prescribed by the doctors at the Flavigny CMPRE on the physical condition of the children taking part in the stay Score between 0 and 20 for each part of the test, with 20 being the best score (and therefore the best physical condition).
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Secondary outcomes (14)
KidScreen52 quality-of-life scale score.
Quality of life scale : a T-score value is calculated. Scores range from 10 to 50, where 10 represents the lowest possible value and thus a very low health-related quality of life and 50 the maximum value, i.e. a very high health-related quality of life.
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Impedance measurement
Recording weight on a balance : Ideally, the patient should have lost weight by the end of the reconditioning stay.
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Exercise test on ergometer
Three-minute warm-up without resistance, then increase in difficulty every minute until you reach 80% of your theoretical maximum heart rate.
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Anamnesis
description of the antecedents
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
6-minute walk test
Walk the maximum distance for 6 minutes
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Energy expenditure index
Functional walking index calculated during a regular, spontaneous 5-minute walk. This index is equal to the ratio of heart rate averaged over the 5th minute to walking speed.
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Gluteal bridge
Physical exercise that helps to strengthen the gluteus muscles (located in the buttocks) and hamstrings. The longer you hold the position, the better is.
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Shirado test
Assessment of abdominal endurance: keep your shoulders off the ground while lying on your back with your feet raised. The maximum duration of this test is three minutes. Low performance if time less than 60 seconds, maximum if time greater than 150 seconds.
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Sorensen test
Assessment of trunk extensor endurance: hold the weight of your trunk in isometric position for as long as possible, with your arms crossed over your chest. The maximum duration of this test is 240 seconds. The longer the position is maintained, the better.
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Timed Up and Down Stairs (TUDS) test
he participant stands 1 foot from the bottom of a 14-step flight of stairs. The participant is instructed to "Quickly, but safely go up the stairs, turn around on the top step (landing) and come all the way down until both feet land on the bottom step (landing." The participants are allowed to choose any method of traversing the stairs. The TUDS score was the time in seconds from the "go" cue until the second foot returned to the bottom landing. Shorter times indicated better functional ability.
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Floor survey test
Evaluation and exercise element designed to teach the subject to get up from the ground using the righting sequence
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Mini Bestest : Each of the 14 tests is graded from 0 to 2. "0" represents the lowest functional level and "2" the highest functional level. Maximal score : 28.
Clinical assessment of postural control
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
The Canadian Occupational Performance Measure
Tool used in occupational therapy to identify people's occupational problems
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
A motivational questionnaire
A tool for assessing involvement and motivation levels : 7 questions score between 0 and 10. 0 = no motivation 10 = total motivation
Measured: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start22 Mar 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Cerebral PalsyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320496
- Sponsor's protocol ID
- IRR-FLAVIGNY-2021-2
- Status last verified
- May 2026
- First submitted
- 5 Feb 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Physical Activity Recovery Stay on the Physical Condition and Quality of Life of Children in a Situation of Physical Deconditioning
- ClinicalTrials.gov ID
- NCT06320496
- Acronym / sponsor ID
- IRR-FLAVIGNY-2021-2
- Conditions
- Children With Cerebral Palsy, Children With Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord EstUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Mar 2024 (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.
A WHO study in 2020 revealed that 81% of adolescents (aged 11-17) do not respect the recommendation of one hour of moderate physical activity per day. In the context of disability, many factors impose limits on physical activity. While the pathology itself induces limitations and restrictions (prolonged sitting time, assisted movement, etc.), organizational constraints also apply to both children and parents, who have to divide their time between work, school and therapeutic care, which is sometimes numerous and varied over the course of a single week. These limitations generate stress and fatigue, and prolonged sedentary periods lead children with chronic illnesses, rare diseases or disabilities into a process of physical deconditioning. The accumulation of sedentary time is detrimental to cardiovascular and metabolic health.
To combat this deconditioning, the 2008 National Physical Activity and Sport Plan (PNAPS) sets out the main guidelines for treatment and implementation. The plan explains that "for patients with chronic illnesses, rare diseases or disabilities, the aim is to encourage care and guidance towards Adapted Physical Activity (APA). The attending physician will be able to identify local therapeutic education programs, rehabilitation services and "sport-santé" offers, to improve access for these patients to supervised local programs". In addition, the plan suggests "developing APA programs in healthcare establishments to enable people with chronic illnesses, rare diseases or disabilities to access health education incorporating practical sessions".
In line with this plan, an exercise reconditioning program has been set up at our facility. This three-month stay includes children with a variety of pathologies, but with a common feature of physical deconditioning.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deconditioning to physical exertion | – | –The children taking part in the return-to-physical-activity program are referred to the Flavigny-sur-Moselle CMPRE for medical consultation due to a state of deconditioning to physical exertion concomitant with a pathological situation. The pathology most frequently encountered during this stay is cerebral palsy. However, the Flavigny CMPRE is accredited in a number of fields (orthopedics, burns, neurology, oncology), and the pathologies of the children referred to this stay are representative of these. These include children with scoliosis, obesity, Guillain-Barré syndrome, cystic fibrosis, Charcot's disease and cancer. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The children taking part in the return-to-physical-activity program are referred to the Flavigny-sur-Moselle CMPRE for medical consultation due to a state of deconditioning to physical exertion concomitant with a pathological situation. The pathology most frequently encountered during this stay is cerebral palsy. However, the Flavigny CMPRE is accredited in a number of fields (orthopedics, burns, neurology, oncology), and the pathologies of the children referred to this stay are representative of these. These include children with scoliosis, obesity, Guillain-Barré syndrome, cystic fibrosis, Charcot's disease and cancer.
Key inclusion criteria (2 listed)
- Children with a pathology (chronic disease, rare disease or disability) in a state of deconditioning to exercise
- Taken in charge at the CMPRE for a stay to resume physical activity
Key exclusion criteria (8 listed)
- Age under 8 and over 18
- Patients undergoing rehabilitation during the stay
- Patients with a significant change in their therapeutic management during the stay
- Significant cognitive impairment preventing comprehension of instructions
- Significant club or leisure sports activity (3x/week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnoform test score
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
To evaluate the effect of the return to physical activity stay prescribed by the doctors at the Flavigny CMPRE on the physical condition of the children taking part in the stay Score between 0 and 20 for each part of the test, with 20 being the best score (and therefore the best physical condition).
14 secondary outcomes
KidScreen52 quality-of-life scale score.
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Impedance measurement
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Exercise test on ergometer
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Anamnesis
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
6-minute walk test
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Energy expenditure index
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Gluteal bridge
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Shirado test
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Sorensen test
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Timed Up and Down Stairs (TUDS) test
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Floor survey test
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
Mini Bestest : Each of the 14 tests is graded from 0 to 2. "0" represents the lowest functional level and "2" the highest functional level. Maximal score : 28.
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
The Canadian Occupational Performance Measure
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
A motivational questionnaire
Time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient
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 8 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children With Cerebral Palsy and Children With Cancer, run by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est 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 2 inclusion and 8 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 8 May 2026. 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 Jonathan Pierret, PhD (+33 3 82 52 6761, jonathan.pierret@ugecam.assurance-maladie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnoform test score (time frame: Day of patient inclusion and 3 months after, day on which the study ends for the patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.