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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lejeune, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01700153
First received: September 26, 2012
Last updated: May 6, 2013
Last verified: May 2013
  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:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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 August 28, 2014