Sensitivity of an Upper Limb Motion Analysis Protocol to Changes in Kinematics and Muscle Activity After Constraint Induced Therapy in Children With Hemiplegia

NCT03099993 | Completed

• 1 other identifier: RC15_0310
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

In France, Cerebral Palsy (CP) affects 1 in 450 births. It results from lesions of the brain, before, during, or shortly after birth. These non-progressive lesions cause muscle impairments, responsible for activity limitations. These muscle impairments include muscle stiffness, and muscle weakness. Children with Unilateral CP (UCP) have these impairments on only one side of the body. To compensate for activity limitations with their impaired arm, these children over-use their non-impaired arm. The objective of constraint-induced therapy (CIT) is to minimize this asymmetry which deteriorates mobility on the impaired side, by forcing the child to only use its impaired arm several hours a day during several weeks of therapy. It is known using clinical tests that this therapy improves the overall motor function of the impaired arm. However, the underlying mechanisms are yet unknown. An understanding of these mechanisms would suggest ways to maximize the effectiveness of this therapy, which requires a significant commitment from the child and its family. The investigaors propose in this project a quantitative and objective evaluation of the effect of CIT on the movements of the impaired arm of children with UCP. The investogators focus their analysis on muscle activation, to assess which aspect of muscle impairments is modified by CIT. To this end, the investigators will use sensors identical to those already used in clinics for the Quantified Gait Analysis of children with CP, recognized since 2006 by the Haute Autorité de Santé as providing key supplementary data in the evaluation of complex gait disorders. Results from this study will provide leads to optimize CIT. Some children could for example benefit from CIT paired with treatments to reduce muscle stiffness or to strengthen muscles

Conditions

Unilateral Cerebral Palsy

Keywords

Unilateral cerebral palsy; kinematics; electromyography; constraint-induced therapy; muscle activation; upper limb; child

Outcome Measures

Primary Outcomes (2)

• Upper limb muscle activation envelopes

  Muscle activation envelopes come from electromyographic signals of upper limb muscles.

  5 weeks

• kinematics during active movements

  Kinematics: angles, velocities, accelerations of the thorax, shoulder, elbow and wrist in the three anatomical plans (sagittal, frontal, transverse).

  5 weeks

Study Arms (3)

A: Healthy volunteers

OTHER

Other: Measurement of maximal forces of elbow pronosupination and flexion-extension

B: Patient with heamiplegia

OTHER

Other: Measurement of maximal forces of elbow pronosupination and flexion-extension

C: Patient with heamiplegia and constraint induced therapy

OTHER

arm with constraint induced therapy (done before the protocol)

Other: Measurement of maximal forces of elbow pronosupination and flexion-extension

Interventions

Measurement of maximal forces of elbow pronosupination and flexion-extension OTHER

Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.

A: Healthy volunteers; B: Patient with heamiplegia; C: Patient with heamiplegia and constraint induced therapy

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants (excluding healthy volunteers) must have hemiparesis.
• Children must be between 6 and 17 years of age. The protocol requires a minimum concentration difficult to obtain for children under 6 years.
• Participants must be enrolled in a health insurance plan.

You may not qualify if:

• Inability to understand or follow instructions during 1h30.
• Physical incapacity to carry out the requested movements

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 46208, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 4, 2017
• Study Start: March 28, 2017
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Locations

FR (1)