Efficacy Study of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental: Robotic-assisted therapy All patients will receive a similar classical rehabilitation as a basis. the 10 patients of this group will receive a supplement of robotic-assisted therapy. |
Other: Robotic-assisted therapy
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.
Other: Classical therapy
conventional therapy will be performed by therapists specialized in neuro-pediatric rehabilitation
|
| Active Comparator: Classical therapy All patients will receive a similar classical rehabilitation as a basis. the 10 patients of this group will receive a supplement of classical rehabilitation. |
Other: Classical therapy
conventional therapy will be performed by therapists specialized in neuro-pediatric rehabilitation
|
Outcome Measures
Primary Outcome Measures
- Kinematic [Change from Baseline in Kinematic at an expected average of 3 months and 6 months]
Secondary Outcome Measures
- Manual Ability Classification System [Change from Baseline in manual ability at an expected average of 3 months and 6 months]
- Quality of Upper Extremity Skills Test [Change from Baseline in quality of upper extremity skills at an expected average of 3 months and 6 months]
- Box and Block test [Change from Baseline in dexterity at an expected average of 3 months and 6 months]
- strength [Change from Baseline in strength at an expected average of 3 months and 6 months]
- Abilhand-Kids scale [Change from Baseline in activity of daily living at an expected average of 3 months and 6 months]
- Pediatric Evaluation of Disability Inventory [Change from Baseline in activity of daily living at an expected average of 3 months and 6 months]
- MHAVIE [Change from Baseline in parents' satisfaction of children activity daily living at an expected average of 3 months and 6 months]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut royal de l'accueil du handicap moteur | Brussel | Belgium | 1200 |
Sponsors and Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
- Principal Investigator: Maxime Gilliaux, PhD student, Université Catholique de Louvain
Study Documents (Full-Text)
None provided.More Information
Publications
- Aisen ML, Kerkovich D, Mast J, Mulroy S, Wren TA, Kay RM, Rethlefsen SA. Cerebral palsy: clinical care and neurological rehabilitation. Lancet Neurol. 2011 Sep;10(9):844-52. doi: 10.1016/S1474-4422(11)70176-4. Review.
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- Bax MC, Flodmark O, Tydeman C. Definition and classification of cerebral palsy. From syndrome toward disease. Dev Med Child Neurol Suppl. 2007 Feb;109:39-41.
- Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7.
- Desrosiers J, Bravo G, Hébert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.
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- Eliasson AC, Krumlinde-Sundholm L, Rösblad B, Beckung E, Arner M, Ohrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006 Jul;48(7):549-54.
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- Feldman AB, Haley SM, Coryell J. Concurrent and construct validity of the Pediatric Evaluation of Disability Inventory. Phys Ther. 1990 Oct;70(10):602-10.
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- Krebs HI, Ladenheim B, Hippolyte C, Monterroso L, Mast J. Robot-assisted task-specific training in cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:140-5. doi: 10.1111/j.1469-8749.2009.03416.x. Review.
- Masiero S, Celia A, Rosati G, Armani M. Robotic-assisted rehabilitation of the upper limb after acute stroke. Arch Phys Med Rehabil. 2007 Feb;88(2):142-9.
- Mehrholz J, Hädrich A, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD006876. doi: 10.1002/14651858.CD006876.pub3. Review. Update in: Cochrane Database Syst Rev. 2015;(11):CD006876.
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- Noreau L, Lepage C, Boissiere L, Picard R, Fougeyrollas P, Mathieu J, Desmarais G, Nadeau L. Measuring participation in children with disabilities using the Assessment of Life Habits. Dev Med Child Neurol. 2007 Sep;49(9):666-71.
- Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18. Review.
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- IONS-Gilliaux-01