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

NCT01700153 | Completed DMC

• 1 other identifier: IONS-Gilliaux-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Robotic-assisted therapy; cerebral palsy; ICF

Outcome Measures

Primary Outcomes (1)

• Kinematic

  Change from Baseline in Kinematic at an expected average of 3 months and 6 months

Secondary Outcomes (7)

• 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

Study Arms (2)

Experimental: Robotic-assisted therapy

EXPERIMENTAL

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; Other: Classical therapy

Classical therapy

ACTIVE COMPARATOR

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

Interventions

Robotic-assisted therapy OTHER

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.

Experimental: Robotic-assisted therapy

Classical therapy OTHER

conventional therapy will be performed by therapists specialized in neuro-pediatric rehabilitation

Classical therapy; Experimental: Robotic-assisted therapy

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Institut royal de l'accueil du handicap moteur

Brussels, 1200, Belgium

Location

Related Publications (20)

• 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. No abstract available.

  PMID: 17370481 BACKGROUND

• 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. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.

  PMID: 16120836 BACKGROUND

• 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. doi: 10.1016/j.apmr.2006.08.334.

  PMID: 17140877 BACKGROUND

• 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.

  PMID: 21849165 BACKGROUND

• Mehrholz J, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006185. doi: 10.1002/14651858.CD006185.pub2.

  PMID: 17943893 BACKGROUND

• 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. doi: 10.1016/j.apmr.2006.10.032.

  PMID: 17270510 BACKGROUND

• 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. doi: 10.1177/1545968308331148. Epub 2009 Feb 23.

  PMID: 19237734 BACKGROUND

• Mehrholz J, Hadrich 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.

  PMID: 22696362 BACKGROUND

• 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.

  PMID: 19740222 BACKGROUND

• 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. doi: 10.1097/PHM.0b013e31818a6aa4.

  PMID: 18936558 BACKGROUND

• 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.

  PMID: 19293759 BACKGROUND

• 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.

  PMID: 19451190 BACKGROUND

• Eliasson AC, Krumlinde-Sundholm L, Rosblad 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. doi: 10.1017/S0012162206001162.

  PMID: 16780622 BACKGROUND

• 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. doi: 10.1111/j.1469-8749.2008.03123.x. Epub 2008 Sep 20.

  PMID: 18811701 BACKGROUND

• Desrosiers J, Bravo G, Hebert 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.

  PMID: 8024419 BACKGROUND

• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

  PMID: 3809245 BACKGROUND

• 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. doi: 10.2340/16501977-0926.

  PMID: 22367455 BACKGROUND

• 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. doi: 10.1212/01.wnl.0000138423.77640.37.

  PMID: 15452296 BACKGROUND

• 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. doi: 10.1093/ptj/70.10.602.

  PMID: 2217539 BACKGROUND

• 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. doi: 10.1111/j.1469-8749.2007.00666.x.

  PMID: 17718822 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Maxime Gilliaux, PhD student

  Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 4, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

BE (1)