Cerebral Palsy (CP)NCT07285837
Intensive Rehabilitation Program for Upper Limb in Children and Adolescents With Cerebral Palsy
A study testing Intensive Rehabilitation in people with Cerebral Palsy (CP), run by Fondation Ellen Poidatz at 1 site in France.
Trial summary
Cerebral palsy is the most common motor disability in children. Individuals with CP often experience significant difficulties in the use of their upper limbs, which affects their autonomy and quality of life. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Intensive Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2025to Dec 2030
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A clinical diagnosis of CP mentioned in the medical record
- Aged between 3 and 17 years inclusive (<18 years)
- Global Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) levels I to IV
- Ability to cooperate, understand and follow simple instructions
- Patient affiliated to the French social security system
- Voluntary patient whose parents have given their consent for their child to participate in the study.
Who cannot join
- Presence of injuries incompatible with participation in the program, or pain rated >3 on the Visual Analogue Scale (VAS)
- Presence of behavioral disorders
- History of botulinum toxin injections or surgical intervention within six months prior to study enrollment.
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
Fondation Ellen Poidatz
Saint-Fargeau-Ponthierry, Île-de-France Region, 77310
About this study
Official title: Effect of an Intensive Rehabilitation Protocol Combining Constraint-Induced Movement Therapy and Bimanual Training on Upper Limb Use and Gross Motor Function in Children and Adolescents With Cerebral Palsy
Cerebral palsy is the most common motor disability in children. Individuals with CP often experience significant difficulties in the use of their upper limbs, which affects their autonomy and quality of life. Conventional rehabilitation, although essential, is often insufficient to compensate for these deficits in a meaningful way.
The French National Authority for Health has issued recommendations for intensifying rehabilitation in order to maximize functional gains in children with CP. Among the intensive approaches that have been studied, two techniques have demonstrated efficacy: Constraint-Induced Movement Therapy (CIMT) and Bimanual Intensive Therapy (BIT).
Read more
CIMT focuses on restricting the use of the unaffected limb to encourage the use of the affected limb, thereby promoting neuroplasticity and functional improvement. In contrast, BIT emphasizes intensive training of both hands simultaneously to enhance coordination and overall upper limb functionality.
At the Ellen Poidatz Foundation, an intensive rehabilitation program has been developed that combines these two complementary approaches. This program, which is already in place, is based on the principles of neuromotor rehabilitation and motor learning. It integrates several methods recommended by the HAS, including Bimanual Intensive Therapy (BIT) such as HABIT (Grade A) or HABIT-ILE (Grade B), Modified Constraint-Induced Movement Therapy (mCIMT) (Grade B), and Adapted Physical Activity (APA) (Grade A).
The aim of this intensive program is to enhance the functional use of the upper limb by improving bimanual coordination, grasping, manipulation, and overall motor function. The program lasts 10 days over a 2-week period and is tailored to the child's age and care setting. It includes approximately 60 hours of rehabilitation for children aged 3 to 8 years and 80 hours for those aged 9 to 17 years, in line with current international recommendations.
The aim of this study is to evaluate the effectiveness of this existing intensive rehabilitation program in improving manual abilities in children with CP. Specifically, the study seeks to objectively assess the benefits of the Habil'Hand+ program and to contribute to the optimization of rehabilitation protocols for this population.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Intensive Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive RehabilitationOther
Children aged 3 to 8 years : 2 weeks program over 10 days including two individual sessions and three group sessions per participant per day combining CIMT and BIT.
Adolescents aged 9 to 17 years in day-hospital care/ in inpatient care: 2 weeks program over 10 days including two individual sessions and three group sessions per participant per day combining CIMT and BIT.
Daily routines, and activities involve functional and playful motor tasks of progressively increasing difficulty.
| Study group | Role | What they receive |
|---|---|---|
| CP children and adolescents | Experimental | The program is tailored to the child's age and care setting. Children aged 3 to 8 years : 2 weeks program over 10 days with a total of 60 hours of CIMT+ BIT in a day-hospital setting.
Adolescents aged 9 to 17 years in day-hospital care : 2 weeks program over 10 days with a total of 80 hours of CIMT+ BIT in a day-hospital setting.
Adolescents aged 9 to 17 years in inpatient care : 2 weeks program over 10 days with a total of 80 hours of CIMT+ BIT in inpatient care. Receives: Other: Intensive Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assessment (AHA) /Both Hands Assessment(BoHA)
The AHA determine a score of natural use of the affected upper limb in standardized activity test. The BoHA is a standardized test designed for children with bilateral cerebral palsy. Both assessments contains 20 items rated on a 4-point scale (4=effective, 3=somewhat effective, 2=ineffective, and 1=does not do). A higher score therefore represents better performance.
Measured: 3 months
Secondary outcomes (7)
Melbourne Assessment 2
Designed to evaluate four aspects of upper limb movement quality in children with neurological impairments: (1) range of motion, (2) accuracy of reach and placement, (3) dexterity in grasping, releasing, and manipulating objects, and (4) movement fluency. The full assessment includes 14 items, requiring the child to reach for, grasp, release, and manipulate simple objects.
Measured: 3 months
Canadian Occupational Performance Measure (COPM)
Used to establish intervention goals that are consistent with the child's needs. The assessment is conducted in four steps: 1. Identification of occupational performance difficulties, 2. Prioritization of these difficulties according to their importance rated on a 10-point ordinal scale, 3. Rating of performance and satisfaction levels for the most important difficulties (up to five difficulties), using 10-point ordinal scales and 4. Re-evaluation (post-intervention) of performance and satisfaction levels for the difficulties identified at baseline.
Measured: 3 months
Goal Attainment Scaling (GAS)
Used to evaluate the effectiveness of an intervention on individualized goals. The process involves the following steps: 1. Define specific goals - establish one or more precise, individualized objectives. 2. Weight the goals - rate each goal according to its importance and level of difficulty. 3.Define expected outcomes - specify the anticipated performance for each goal. 4.Establish the baseline - record the child's initial level of performance for each goal. 5. Calculate the GAS score - quantify goal attainment post-intervention using the standardized GAS formula.
Measured: 3 months
Children's Hand Experience Questionnaire (CHEQ)
Used to assess the spontaneous use of the affected upper limb during bimanual activities of daily living. The Mini-CHEQ is designed for children aged 3 to 8 years and evaluates 21 activities, while the CHEQ 2.0 is intended for children aged 6 to 18 years and assesses 27 activities. The activities are presented in a random order. The questionnaire provides information on whether the activities are performed independently and whether one or both hands are used.
Measured: 3 months
Box and Blocks test
Used to evaluate unilateral gross manual dexterity. Participant must transfer, one by one, with one hand, a maximum number of cubes from one side to the other of the box in 1 minute. A higher score represents better performance.
Measured: 3 months
Gross Motor Function Measure (GMFM)
Used to assess gross motor function in children with cerebral palsy. The GMFM-66 evaluates five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping.
Measured: 3 months
6 minutes walking test
To quantify changes in gait parameters (speed, cadence, step length). The patient is instructed to walk for 6 minutes in an unobstructed corridor. The distance walked is recorded for the calculation of walking speed. Fatigue is assessed with a Borg scale and heart rate is continuously recorded.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start21 Nov 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ellen Poidatz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285837
- Sponsor's protocol ID
- Habil'Hand+
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Intensive Rehabilitation Protocol Combining Constraint-Induced Movement Therapy and Bimanual Training on Upper Limb Use and Gross Motor Function in Children and Adolescents With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07285837
- Acronym / sponsor ID
- Habil'Hand+
- Conditions
- Cerebral Palsy (CP)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondation Ellen PoidatzUniversity, hospital or other
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 16 Dec 2025 (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.
Cerebral palsy is the most common motor disability in children. Individuals with CP often experience significant difficulties in the use of their upper limbs, which affects their autonomy and quality of life. Conventional rehabilitation, although essential, is often insufficient to compensate for these deficits in a meaningful way.
The French National Authority for Health has issued recommendations for intensifying rehabilitation in order to maximize functional gains in children with CP. Among the intensive approaches that have been studied, two techniques have demonstrated efficacy: Constraint-Induced Movement Therapy (CIMT) and Bimanual Intensive Therapy (BIT).
CIMT focuses on restricting the use of the unaffected limb to encourage the use of the affected limb, thereby promoting neuroplasticity and functional improvement. In contrast, BIT emphasizes intensive training of both hands simultaneously to enhance coordination and overall upper limb functionality.
At the Ellen Poidatz Foundation, an intensive rehabilitation program has been developed that combines these two complementary approaches. This program, which is already in place, is based on the principles of neuromotor rehabilitation and motor learning. It integrates several methods recommended by the HAS, including Bimanual Intensive Therapy (BIT) such as HABIT (Grade A) or HABIT-ILE (Grade B), Modified Constraint-Induced Movement Therapy (mCIMT) (Grade B), and Adapted Physical Activity (APA) (Grade A).
The aim of this intensive program is to enhance the functional use of the upper limb by improving bimanual coordination, grasping, manipulation, and overall motor function. The program lasts 10 days over a 2-week period and is tailored to the child's age and care setting. It includes approximately 60 hours of rehabilitation for children aged 3 to 8 years and 80 hours for those aged 9 to 17 years, in line with current international recommendations.
The aim of this study is to evaluate the effectiveness of this existing intensive rehabilitation program in improving manual abilities in children with CP. Specifically, the study seeks to objectively assess the benefits of the Habil'Hand+ program and to contribute to the optimization of rehabilitation protocols for this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CP children and adolescents | Experimental | Other: Intensive RehabilitationThe program is tailored to the child's age and care setting. Children aged 3 to 8 years : 2 weeks program over 10 days with a total of 60 hours of CIMT+ BIT in a day-hospital setting. Adolescents aged 9 to 17 years in day-hospital care : 2 weeks program over 10 days with a total of 80 hours of CIMT+ BIT in a day-hospital setting. Adolescents aged 9 to 17 years in inpatient care : 2 weeks program over 10 days with a total of 80 hours of CIMT+ BIT in inpatient care. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- A clinical diagnosis of CP mentioned in the medical record
- Aged between 3 and 17 years inclusive (<18 years)
- Global Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS) levels I to IV
- Ability to cooperate, understand and follow simple instructions
- Patient affiliated to the French social security system
Key exclusion criteria (3 listed)
- Presence of injuries incompatible with participation in the program, or pain rated >3 on the Visual Analogue Scale (VAS)
- Presence of behavioral disorders
- History of botulinum toxin injections or surgical intervention within six months prior to study enrollment.
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 |
|---|---|---|
| Intensive RehabilitationChildren aged 3 to 8 years : 2 weeks program over 10 days including two individual sessions and three group sessions per participant per day combining CIMT and BIT. Adolescents aged 9 to 17 years in day-hospital care/ in inpatient care: 2 weeks program over 10 days including two individual sessions and three group sessions per participant per day combining CIMT and BIT. Daily routines, and activities involve functional and playful motor tasks of progressively increasing difficulty. | Other | CP children and adolescents |
Primary outcome
Assisting Hand Assessment (AHA) /Both Hands Assessment(BoHA)
Time frame: 3 months
The AHA determine a score of natural use of the affected upper limb in standardized activity test. The BoHA is a standardized test designed for children with bilateral cerebral palsy. Both assessments contains 20 items rated on a 4-point scale (4=effective, 3=somewhat effective, 2=ineffective, and 1=does not do). A higher score therefore represents better performance.
7 secondary outcomes
Melbourne Assessment 2
Time frame: 3 months
Canadian Occupational Performance Measure (COPM)
Time frame: 3 months
Goal Attainment Scaling (GAS)
Time frame: 3 months
Children's Hand Experience Questionnaire (CHEQ)
Time frame: 3 months
Box and Blocks test
Time frame: 3 months
Gross Motor Function Measure (GMFM)
Time frame: 3 months
6 minutes walking test
Time frame: 3 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 29 Jan 2026.
- Fondation Ellen Poidatz Habil'Hand+Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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?
A study testing Intensive Rehabilitation in people with Cerebral Palsy (CP), run by Fondation Ellen Poidatz 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 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 29 Jan 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 Éric Desailly, PhD (+33160652765, eric.desailly@fondationpoidatz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assisting Hand Assessment (AHA) /Both Hands Assessment(BoHA) (time frame: 3 months). 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 29 Jan 2026.