Recruiting

Bimanual Therapy

Sponsor:

Laval University

Code:

NCT05423171

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Intensive bimanual therapy

Study Details

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.

Conditions

Cerebral Palsy

Study ID

NCT05423171

Start date

Jun 30, 2021

Status verified date

Jun, 2022

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Intensive bimanual therapy

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

Primary outcome measure

  • Magnetic Resonance Imaging (MRI) [ Time Frame: Measured prior to the intervention. ]
  • Robotic evaluation - Visually guided reaching [ Time Frame: Measured prior to the intervention. ]
  • Robotic evaluation - Visually guided reaching [ Time Frame: Measured one week post-intervention. ]
  • Robotic evaluation - Visually guided reaching [ Time Frame: Measured 6-month post-intervention. ]
  • Robotic evaluation - Object hit [ Time Frame: Measured prior to the intervention. ]
  • Robotic evaluation - Object hit [ Time Frame: Measured one week post-intervention. ]
  • Robotic evaluation - Object hit [ Time Frame: Measured 6-month post-intervention. ]
  • Robotic evaluation - Ball on bar [ Time Frame: Measured prior to the intervention. ]
  • Robotic evaluation - Ball on bar [ Time Frame: Measured one week post-intervention. ]
  • Robotic evaluation - Ball on bar [ Time Frame: Measured 6-month post-intervention. ]
  • Robotic evaluation - Arm-position matching [ Time Frame: Measured prior to the intervention. ]
  • Robotic evaluation - Arm-position matching [ Time Frame: Measured one week post-intervention. ]
  • Robotic evaluation - Arm-position matching [ Time Frame: Measured 6-month post-intervention. ]
  • Spontaneous use of both arms [ Time Frame: Measured during two-days prior to the intervention. ]
  • Spontaneous use of both arms [ Time Frame: Measured two days during the intervention. ]
  • Spontaneous use of both arms [ Time Frame: Measured during two-days one week post-intervention. ]
  • Spontaneous use of both arms [ Time Frame: Measured during two-days 6-month post-intervention. ]
  • Clinical evaluation -Two-point discrimination test (TPDT) [ Time Frame: Measured prior to the intervention. ]
  • Clinical evaluation -Two-point discrimination test (TPDT) [ Time Frame: Measured one week post-intervention. ]
  • Clinical evaluation -Two-point discrimination test (TPDT) [ Time Frame: Measured 6-month post-intervention. ]
  • Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF) [ Time Frame: Measured prior to the intervention. ]
  • Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF) [ Time Frame: Measured one week post-intervention. ]
  • Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF) [ Time Frame: Measured 6-month post-intervention. ]
  • Clinical evaluation - Box and Blocks Test (BBT) [ Time Frame: Measured prior to the intervention. ]
  • Clinical evaluation - Box and Blocks Test (BBT) [ Time Frame: Measured one week post-intervention. ]
  • Clinical evaluation - Box and Blocks Test (BBT) [ Time Frame: Measured 6-month post-intervention. ]
  • Clinical evaluation - Assisting Hand Assessment (AHA) [ Time Frame: Measured prior to the intervention. ]
  • Clinical evaluation - Assisting Hand Assessment (AHA) [ Time Frame: Measured one week post-intervention. ]
  • Clinical evaluation - Assisting Hand Assessment (AHA) [ Time Frame: Measured 6-month post-intervention. ]
  • Clinical evaluation - Two-Arm Coordination Test (TACT) [ Time Frame: Measured prior to the intervention. ]
  • Clinical evaluation - Two-Arm Coordination Test (TACT) [ Time Frame: Measured one week post-intervention. ]
  • Clinical evaluation - Two-Arm Coordination Test (TACT) [ Time Frame: Measured 6-month post-intervention. ]
  • Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R) [ Time Frame: Measured prior to the intervention. ]
  • Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R) [ Time Frame: Measured one week post-intervention. ]
  • Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R) [ Time Frame: Measured 6-month post-intervention. ]

Central Contacts and Locations

Central contacts

Catherine Mercier, PhD;OT

141852991416701catherine.mercier@rea.ulaval.ca

Locations

Université Laval

Recruiting

Québec, Canada, G1V 0A6

Contacts

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

141852991416701catherine.mercier@rea.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Jun 21, 2022

Last verified

Jun, 2022

Keywords

  • Intensive bimanual therapy
  • Upper limb motor function
  • Rehabilitation
  • Motor learning
  • Accelerometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2022-06-21.