Efficacy Study of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy - Full Text View

Purpose

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	Intervention
Cerebral Palsy	Other: Robotic-assisted therapy Other: Classical therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cerebral Palsy Paralysis Rehabilitation

U.S. FDA Resources

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:

Kinematic [ Time Frame: Change from Baseline in Kinematic at an expected average of 3 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Manual Ability Classification System [ Time Frame: Change from Baseline in manual ability at an expected average of 3 months and 6 months ] [ Designated as safety issue: No ]
Quality of Upper Extremity Skills Test [ Time Frame: Change from Baseline in quality of upper extremity skills at an expected average of 3 months and 6 months ] [ Designated as safety issue: No ]
Box and Block test [ Time Frame: Change from Baseline in dexterity at an expected average of 3 months and 6 months ] [ Designated as safety issue: No ]
strength [ Time Frame: Change from Baseline in strength at an expected average of 3 months and 6 months ] [ Designated as safety issue: No ]
Abilhand-Kids scale [ Time Frame: Change from Baseline in activity of daily living at an expected average of 3 months and 6 months ] [ Designated as safety issue: No ]
Pediatric Evaluation of Disability Inventory [ Time Frame: Change from Baseline in activity of daily living at an expected average of 3 months and 6 months ] [ Designated as safety issue: No ]
MHAVIE [ Time Frame: Change from Baseline in parents' satisfaction of children activity daily living at an expected average of 3 months and 6 months ] [ Designated as safety issue: No ]

Enrollment:	16
Study Start Date:	September 2012
Study Completion Date:	May 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Show Detailed Description

Eligibility

Ages Eligible for Study:	4 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700153

Locations

Belgium
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

More Information

Publications:

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.

Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43.

Ward NS. The neural substrates of motor recovery after focal damage to the central nervous system. Arch Phys Med Rehabil. 2006 Dec;87(12 Suppl 2):S30-5. Review.

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. Review.

Mehrholz J, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006185. 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.

Housman SJ, Scott KM, Reinkensmeyer DJ. A randomized controlled trial of gravity-supported, computer-enhanced arm exercise for individuals with severe hemiparesis. Neurorehabil Neural Repair. 2009 Jun;23(5):505-14. Epub 2009 Feb 23.

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. Review.

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. Review.

Fasoli SE, Fragala-Pinkham M, Hughes R, Hogan N, Krebs HI, Stein J. Upper limb robotic therapy for children with hemiplegia. Am J Phys Med Rehabil. 2008 Nov;87(11):929-36.

Frascarelli F, Masia L, Di Rosa G, Cappa P, Petrarca M, Castelli E, Krebs HI. The impact of robotic rehabilitation in children with acquired or congenital movement disorders. Eur J Phys Rehabil Med. 2009 Mar;45(1):135-41.

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. Epub 2009 May 18. Review.

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.

Klingels K, De Cock P, Desloovere K, Huenaerts C, Molenaers G, Van Nuland I, Huysmans A, Feys H. Comparison of the Melbourne Assessment of Unilateral Upper Limb Function and the Quality of Upper Extremity Skills Test in hemiplegic CP. Dev Med Child Neurol. 2008 Dec;50(12):904-9. Epub 2008 Sep 20.

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.

Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7.

Gilliaux M, Lejeune T, Detrembleur C, Sapin J, Dehez B, Stoquart G. A robotic device as a sensitive quantitative tool to assess upper limb impairments in stroke patients: a preliminary prospective cohort study. J Rehabil Med. 2012 Mar;44(3):210-7.

Arnould C, Penta M, Renders A, Thonnard JL. ABILHAND-Kids: a measure of manual ability in children with cerebral palsy. Neurology. 2004 Sep 28;63(6):1045-52.

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.

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.

Responsible Party:	Lejeune, Professor, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:	NCT01700153 History of Changes
Other Study ID Numbers:	IONS-Gilliaux-01
Study First Received:	September 26, 2012
Last Updated:	May 6, 2013
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Robotic-assisted therapy
cerebral palsy
ICF

Additional relevant MeSH terms:

Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013