Cerebral Palsy Clinical Trial
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.
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 18 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Institut royal de l'accueil du handicap moteur | Brussel |
Lead Sponsor | Collaborator |
---|---|
Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
Belgium,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kinematic | Change from Baseline in Kinematic at an expected average of 3 months and 6 months | No | |
Secondary | Manual Ability Classification System | Change from Baseline in manual ability at an expected average of 3 months and 6 months | No | |
Secondary | 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 | No | |
Secondary | Box and Block test | Change from Baseline in dexterity at an expected average of 3 months and 6 months | No | |
Secondary | strength | Change from Baseline in strength at an expected average of 3 months and 6 months | No | |
Secondary | Abilhand-Kids scale | Change from Baseline in activity of daily living at an expected average of 3 months and 6 months | No | |
Secondary | Pediatric Evaluation of Disability Inventory | Change from Baseline in activity of daily living at an expected average of 3 months and 6 months | No | |
Secondary | MHAVIE | Change from Baseline in parents' satisfaction of children activity daily living at an expected average of 3 months and 6 months | No |
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