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

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ClinicalTrials.gov Identifier: NCT01700153
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : May 8, 2013
Sponsor:
Information provided by (Responsible Party):

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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : September 2012
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 :
  1. Kinematic [ Time Frame: Change from Baseline in Kinematic at an expected average of 3 months and 6 months ]

Secondary Outcome Measures :
  1. Manual Ability Classification System [ Time Frame: Change from Baseline in manual ability at an expected average of 3 months and 6 months ]
  2. 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 ]
  3. Box and Block test [ Time Frame: Change from Baseline in dexterity at an expected average of 3 months and 6 months ]
  4. strength [ Time Frame: Change from Baseline in strength at an expected average of 3 months and 6 months ]
  5. Abilhand-Kids scale [ Time Frame: Change from Baseline in activity of daily living at an expected average of 3 months and 6 months ]
  6. 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 ]
  7. MHAVIE [ Time Frame: Change from Baseline in parents' satisfaction of children activity daily living at an expected average of 3 months and 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013

Keywords provided by Lejeune, Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Robotic-assisted therapy
cerebral palsy
ICF

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases