Intensive Bimanual Intervention in Cerebral Palsy Children

NCT ID: NCT05423171

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2027-01-30

Brief Summary

Motor disorders related to cerebral palsy are often accompanied by sensory, cognitive, perceptive, communication and behavioural impairments. It has already been shown that intensive bimanual intervention can improve arm movement, but its impact on the spontaneous use of the most affected arm in everyday life remains to be established. This project aims to understand the impacts of an intensive bimanual therapy on uni- and bi-manual motor functions as well as the spontaneous use of the most affected arm. Predictive value of neuroimaging variables will also be assessed.

Detailed Description

Most activities of everyday life require the use of both hands in a coordinated manner. Motor disorders related to cerebral palsy lead to activity limitations due to motor function disturbances. It has already been shown that intensive bimanual intervention can improve arm movement, but its impact on the spontaneous use of the most affected arm in everyday life remains to be established. This project aims to understand the impacts of intensive bimanual therapy on the motor functions of both arms (working together or in isolation) as well as on the spontaneous use of the most affected limb. Predictive value of neuroimaging variables will also be assessed. Thirty children living with cerebral palsy will be recruited over a 5-year period. The intervention consists of a day camp, where a small group of participants will be stimulated (one worker per child) to do activities using both hands 6 hours/day for 10 days. There will be three periods of evaluation (pre-intervention, post-intervention and 6-month follow-up). These evaluation periods consist of neuroimaging assessment, clinical evaluation, robotic evaluation and movement evaluation using inertial control units. The use of more accurate measurements of sensorimotor arm functions using robotic systems will clarify the relationship between measurements of brain function and clinical improvements, to better understand the significant variability observed in response to interventions.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MANUS

Children and youth living with cerebral palsy will take part in a 60-hour intensive bimanual therapy at Peps at Université Laval, during which they will play games and exercise to promote spontaneous use of the most affected hand. Participants will take part to pre-evaluation and 1-week and 6-month post-intervention.

Group Type: EXPERIMENTAL

Intensive bimanual therapy

Intervention Type: OTHER

60-hour intensive therapy promoting the use of both hands (ex: bimanual activities, games,...)

Interventions

Intensive bimanual therapy

60-hour intensive therapy promoting the use of both hands (ex: bimanual activities, games,...)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Having a diagnosis of cerebral palsy or spastic hemiparesis encephalopathy
• Having sensorimotor deficits of one or both upper limb (spastic hemiparesis with a dominance on one side of the body; Manual Ability Classification System (MACS) level

1, 2 or 3);

• Having cognitive capacities to understand and perform task of the study.

Exclusion Criteria

• Presenting other significant health problem which may interfere with the requested task or with the clinical intervention;
• Having Botox injection in one or both upper limbs with the 4 months prior to the intervention;
• Presenting significant uncorrected visual deficits.

N.B. Having a ferromagnetic implant is not an exclusion criterion, such participant will be eligible but will not perform the MRI.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Catherine Mercier

Full Professor, Université Laval, Scientific Director, Cirris

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Université Laval

Québec, , Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Catherine Mercier, PhD;OT

Role: CONTACT

catherine.mercier@rea.ulaval.ca

141852991416701

Facility Contacts

Mercier Catherine, Ph.D.;O.T.

Role: primary

catherine.mercier@rea.ulaval.ca

141852991416701

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: First participation

View Document

Document Type: Informed Consent Form: Second participation and more

View Document

Other Identifiers

Manœuvre

Identifier Type: -

Identifier Source: org_study_id