Efficacy Study of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral Palsy (CP) is a major cause of impairments in child population. This disease
      justifies an intensive and prolonged multidisciplinary rehabilitation which can be optimised
      by robotics.

      Our team has developed a robot designed to rehabilitate the child's upper limb. This robot
      allows the patient to perform active, passive, or assisted exercises.

      This therapy is designed to promote motor development in children with CP. Its finality is to
      improve patients' quality of life and participation.

      Several pilot studies evaluated the efficacy of robotic assisted therapy in children with CP
      but none RCT has been done.

      Then, the aim of the study is to evaluate the efficacy of robotic-assisted therapy in
      children with cerebral palsy by evaluating the 3 fields of the ICF (International
      Classification of Functioning, Disability and Health) and performing a prospective randomized
      controlled single blind trial. Therefore, all patients will benefit from a classical
      rehabilitation as a basis. Furthermore, patients of the control and experimental groups will
      receive a supplement of classical rehabilitation and robotic-assisted therapy, respectively.
    

Detailed description: 
      INTRODUCTION

      Cerebral Palsy (CP) is a major cause of impairments in child population. Indeed, CP affects
      two births per thousand (1). The brain damage is expressed by different neurological
      impairments and functional disabilities. These disabilities justify intensive and sustained
      multidisciplinary rehabilitation to reduce neurological impairments, to improve the
      activities and participation of patients, and, ultimately, their quality of life (2, 3, 4).

      Robotics interest has already been shown for lower limb rehabilitation (5). The development
      of the upper limb rehabilitation robotic devices started later. To better stimulate brain
      plasticity, these tools meet the actual recommendations existing in CP's rehabilitation (4).
      Indeed, the robots allow the execution of a large number of movements whose quality is
      controlled (6). A visual interface gives the patient a feedback of its movements (7), and
      offers exercises oriented functional tasks that have meaning for him (8) and the possibly
      dive into a virtual reality. All these elements justify the clinical development of robots to
      assist the therapists.

      In children with CP, several pilot studies have verified the clinical applicability of these
      tools (9-11). However, no randomized controlled study has been performed to evaluate the
      effectiveness of robotic-assisted therapy in children with CP (12). Moreover, no study
      evaluated the effect of these therapies on the three areas of the ICF : Many studies focus on
      impairments (e.g. muscle) without assessing the functional capacity of the patient: what
      about their ability in every day life?

      OBJECTIVES

      To perform a prospective, randomized, controlled, single blind trial to assess the efficacy
      of robotic-assisted therapy in children with cerebral palsy by evaluating the three fields of
      the ICF.

      METHODS

      Twenty patients enrolled at the "Institut Royal de l'Accueil du Handicap Moteur" (IRAHM)
      (1200 Brussels) will be included according to the following criteria: CP, whose location is
      unilateral (hemiplegia) or bilateral (diplegia, quadriplegia), with a MACS (Manual Ability
      Classification System) score > 1 (moderate to severe motor impairments) (13). The exclusion
      criteria are the following: injection in the upper member of botulinum toxin within 6 months
      or intrathecal baclofen used for the upper limb, an unstable clinical condition
      contraindicating the upper limb rehabilitation treatments, cognitive disorders preventing the
      understanding of the instructions or other neurological or orthopedic pathology affecting the
      upper limb.

      A randomisation of patients in two groups (control and experimental) will be performed, using
      a stratified randomization method to ensure the equivalence of the two groups for age, the
      location of the symptoms (diplegia, quadriplegia, left or right hemiplegia) and motor
      neurological impairments (MACS score).

      At IRAHM, each child benefits of 3 physiotherapy sessions and 2 occupational therapy sessions
      per week. Each session lasts 45 minutes. The children in the control group will see no change
      in their treatment. In the experimental group, 1 physiotherapy session and 1 occupational
      therapy session will be replaced by two sessions of intensive rehabilitation of the arm with
      the robot. In total for each group, each child will benefit from 40 sessions of 45 minutes
      over 8 weeks therapy

      Patients will be evaluated three times in the study: before the start of treatments, at the
      end of treatments, and 3 months after the end of treatments.

      Functional assessments will be carried out according to a protocol exploring the three fields
      of the ICF. Impairments will be evaluated by the score of Quality of Upper Extremity Skills
      Test (14), MACS (13), and the Box and Block test (15). Then, spasticity (with two scales),
      kinematics and strength of the paretic arm will be evaluated using the modified Ashworth and
      Tardieu scales, the ReaPLAN robot and a dynamometer, respectively (9, 16, 17). Disability
      will be evaluated via Abilhand-kids (18) and Pediatric Evaluation of Disability Inventory
      (19). Participation restrictions will be evaluated via the MHAVIE questionnaire (20). All
      assessments will be carried out by a occupational therapist, which will be not informed the
      group that the child is assigned (single-blind). All rehabilitation and assessment sessions
      will be conducted at the IRAHM.

      PERSPECTIVES

      From this study, we hope to demonstrate the efficacy of robotic-assisted therapy in children
      with cerebral palsy by evaluating the three fields of the ICF. These results could prove that
      this tool can be a significant complement for the CP rehabilitation.
    

Intervention name(s): Robotic-assisted therapy; Classical therapy
Intervention type(s): Other; Other
Intervention description(s): This robotic device is designed to intensively rehabilitate the upper limb. Indeed, this robot allows the patient to perform a lot of active, passive, or assisted exercises. The level of assistance is determined and provided by the robot in function of the patient capacity.; conventional therapy will be performed by therapists specialized in neuro-pediatric rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Robotic-assisted therapy; cerebral palsy; ICF