Intensive Rehabilitation Program for Upper Limb in Children and Adolescents With Cerebral Palsy

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).

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 Overview

• Status: Recruiting
• Conditions: Cerebral Palsy (CP)
• Intervention / Treatment: Other: Intensive Rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Éric Desailly, PhD; Phone Number: +33160652765; Email: eric.desailly@fondationpoidatz.com

Study Locations

• France
  • Île-de-France Region
    • Saint-Fargeau-Ponthierry, Île-de-France Region, France, 77310
      • Recruiting
      • Fondation Ellen Poidatz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CP children and adolescents; 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.

Other: Intensive Rehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	3 months

Collaborators and Investigators

• Sponsor: Fondation Ellen Poidatz

Publications and helpful links

Helpful Links

• Fondation Ellen Poidatz Habil'Hand+

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Habil'Hand+

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No