Clinical trial NCT01700153: Efficacy Study of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy
Official title: Study of the Effectiveness of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy by Evaluating the 3 Fields of the ICF: A Prospective, Randomized, Controlled, Simple Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Robotic-assisted therapy
cerebral palsy
ICF
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy (hemi, quadri or di-plegia)
* MACS \> 1/5 (moderate to severe impairments)

Exclusion Criteria:

* Botulinum toxin injection in the upper limb muscles
* Intrathecal Baclofen for the upper limb spasticity
* an unstable clinical condition contraindicating the upper limb rehabilitation treatments
* cognitive disorders preventing the understanding of the instructions
* other neurological or orthopedic pathology affecting the upper limb.

Primary outcomes:
measure: Kinematic
timeFrame: Change from Baseline in Kinematic at an expected average of 3 months and 6 months
Secondary outcomes:
measure: Manual Ability Classification System
timeFrame: Change from Baseline in manual ability at an expected average of 3 months and 6 months
measure: Quality of Upper Extremity Skills Test
timeFrame: Change from Baseline in quality of upper extremity skills at an expected average of 3 months and 6 months
measure: Box and Block test
timeFrame: Change from Baseline in dexterity at an expected average of 3 months and 6 months
measure: strength
timeFrame: Change from Baseline in strength at an expected average of 3 months and 6 months
measure: Abilhand-Kids scale
timeFrame: Change from Baseline in activity of daily living at an expected average of 3 months and 6 months
measure: Pediatric Evaluation of Disability Inventory
timeFrame: Change from Baseline in activity of daily living at an expected average of 3 months and 6 months
measure: MHAVIE
timeFrame: Change from Baseline in parents' satisfaction of children activity daily living at an expected average of 3 months and 6 months
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Institut royal de l'accueil du handicap moteur
Study officials:
affiliation: Université Catholique de Louvain
name: Maxime Gilliaux, PhD student
role: PRINCIPAL_INVESTIGATOR
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