Intensive Bimanual Intervention in Cerebral Palsy Children

Predictors of Response to an Intensive Bimanual Intervention in Children With Cerebral Palsy

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Intensive bimanual therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Mercier, PhD;OT; Phone Number: 141852991416701; Email: catherine.mercier@rea.ulaval.ca

Study Locations

• Canada
  • Québec, Canada, G1V 0A6
    • Recruiting
    • Université Laval
    • Contact: Mercier Catherine, Ph.D.;O.T.; Phone Number: 141852991416701; Email: catherine.mercier@rea.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Intensive bimanual therapy; 60-hour intensive therapy promoting the use of both hands (ex: bimanual activities, games,...)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Magnetic Resonance Imaging (MRI)	Neurophysiological evaluation	Measured prior to the intervention.
Robotic evaluation - Visually guided reaching	The participant must reach as quickly and accurately as possible 4 targets spread over a radius of 10 cm around the starting target, presented in a pseudo-random order (total of 32 reaching movements)	Measured prior to the intervention.
Robotic evaluation - Visually guided reaching	The participant must reach as quickly and accurately as possible 4 targets spread over a radius of 10 cm around the starting target, presented in a pseudo-random order (total of 32 reaching movements)	Measured one week post-intervention.
Robotic evaluation - Visually guided reaching	The participant must reach as quickly and accurately as possible 4 targets spread over a radius of 10 cm around the starting target, presented in a pseudo-random order (total of 32 reaching movements)	Measured 6-month post-intervention.
Robotic evaluation - Object hit	The participant must hit the balls with the hand of they choice, each successful contact generating haptic feedback.	Measured prior to the intervention.
Robotic evaluation - Object hit	The participant must hit the balls with the hand of they choice, each successful contact generating haptic feedback.	Measured one week post-intervention.
Robotic evaluation - Object hit	The participant must hit the balls with the hand of they choice, each successful contact generating haptic feedback.	Measured 6-month post-intervention.
Robotic evaluation - Ball on bar	Four targets are successively presented to the participant, the objective of the task is to move the ball into each target as quickly and accurately as possible.	Measured prior to the intervention.
Robotic evaluation - Ball on bar	Four targets are successively presented to the participant, the objective of the task is to move the ball into each target as quickly and accurately as possible.	Measured one week post-intervention.
Robotic evaluation - Ball on bar	Four targets are successively presented to the participant, the objective of the task is to move the ball into each target as quickly and accurately as possible.	Measured 6-month post-intervention.
Robotic evaluation - Arm-position matching	In this proprioception task the sense of upper limb position is evaluated	Measured prior to the intervention.
Robotic evaluation - Arm-position matching	In this proprioception task the sense of upper limb position is evaluated	Measured one week post-intervention.
Robotic evaluation - Arm-position matching	In this proprioception task the sense of upper limb position is evaluated	Measured 6-month post-intervention.
Spontaneous use of both arms	The unilateral and bilateral functions will be quantified by summing the activities detected at the upper limbs with accelerometers, allowing to obtain use-ratio of each limb.	Measured during two-days prior to the intervention.
Spontaneous use of both arms	The unilateral and bilateral functions will be quantified by summing the activities detected at the upper limbs with accelerometers, allowing to obtain use-ratio of each limb.	Measured two days during the intervention.
Spontaneous use of both arms	The unilateral and bilateral functions will be quantified by summing the activities detected at the upper limbs with accelerometers, allowing to obtain use-ratio of each limb.	Measured during two-days one week post-intervention.
Spontaneous use of both arms	The unilateral and bilateral functions will be quantified by summing the activities detected at the upper limbs with accelerometers, allowing to obtain use-ratio of each limb.	Measured during two-days 6-month post-intervention.
Clinical evaluation -Two-point discrimination test (TPDT)	Sensitive test to determine tactile threshold	Measured prior to the intervention.
Clinical evaluation -Two-point discrimination test (TPDT)	Sensitive test to determine tactile threshold	Measured one week post-intervention.
Clinical evaluation -Two-point discrimination test (TPDT)	Sensitive test to determine tactile threshold.	Measured 6-month post-intervention.
Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)	Seven standardized tasks to evaluate the unimanual function. 6 tasks. Sub-task score is the time to complete the task (a maximum of 120s is allowed per task) and the total score is the total time to perform the six tasks (maximum of 720s). Higher time means worse outcome.	Measured prior to the intervention.
Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)	Seven standardized tasks to evaluate the unimanual function. 6 tasks. Sub-task score is the time to complete the task (a maximum of 120s is allowed per task) and the total score is the total time to perform the six tasks (maximum of 720s). Higher time means worse outcome.	Measured one week post-intervention.
Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)	Seven standardized tasks to evaluate the unimanual function	Measured 6-month post-intervention.
Clinical evaluation - Box and Blocks Test (BBT)	Measurement of manual dexterity of each hand. The participant must take one block at a time with one hand to transfer it to the other side of the box.	Measured prior to the intervention.
Clinical evaluation - Box and Blocks Test (BBT)	Measurement of manual dexterity of each hand. The participant must take one block at a time with one hand to transfer it to the other side of the box.	Measured one week post-intervention.
Clinical evaluation - Box and Blocks Test (BBT)	Measurement of manual dexterity of each hand. The participant must take one block at a time with one hand to transfer it to the other side of the box.	Measured 6-month post-intervention.
Clinical evaluation - Assisting Hand Assessment (AHA)	This test consists of standardized tasks with toys during a semi-structured game session. The test is recorded, and the video is analyzed and scored later. Logit-based 0 to 100 AHA-unit scale (score 0-100; better score means better outcome).	Measured prior to the intervention.
Clinical evaluation - Assisting Hand Assessment (AHA)	This test consists of standardized tasks with toys during a semi-structured game session. The test is recorded, and the video is analyzed and scored later. Logit-based 0 to 100 AHA-unit scale (score 0-100; better score means better outcome).	Measured one week post-intervention.
Clinical evaluation - Assisting Hand Assessment (AHA)	This test consists of standardized tasks with toys during a semi-structured game session. The test is recorded, and the video is analyzed and scored later. Logit-based 0 to 100 AHA-unit scale (score 0-100; better score means better outcome).	Measured 6-month post-intervention.
Clinical evaluation - Two-Arm Coordination Test (TACT)	Evaluation of the constrained bilateral use of both upper limbs with an electronic tracking device (eight tests; four clockwise and four counter-clockwise).	Measured prior to the intervention.
Clinical evaluation - Two-Arm Coordination Test (TACT)	Evaluation of the constrained bilateral use of both upper limbs with an electronic tracking device (eight tests; four clockwise and four counter-clockwise).	Measured one week post-intervention.
Clinical evaluation - Two-Arm Coordination Test (TACT)	Evaluation of the constrained bilateral use of both upper limbs with an electronic tracking device (eight tests; four clockwise and four counter-clockwise).	Measured 6-month post-intervention.
Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R)	Visual perception test that assesses consistency of form, spatial orientation, discrimination, memory and visual closure (Score: 0 - 40; better score means better outcome).	Measured prior to the intervention.
Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R)	Visual perception test that assesses consistency of form, spatial orientation, discrimination, memory and visual closure (Score: 0 - 40; better score means better outcome).	Measured one week post-intervention.
Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R)	Visual perception test that assesses consistency of form, spatial orientation, discrimination, memory and visual closure (Score: 0 - 40; better score means better outcome).	Measured 6-month post-intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)	CHEQ is a 29 item child-completed questionnaire that examines how the weaker/affected limb is used in everyday activities. It presents a list of common daily activities that typically require use of two hands. The child then rates the time required, the efficacy of grasp, and how bothered they feel by their hand function on the task. Total score transformed by a Rasch analysis into a scale of 0-100 units (better score means better outcome).	Measured prior to the intervention.
Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)	CHEQ is a 29 item child-completed questionnaire that examines how the weaker/affected limb is used in everyday activities. It presents a list of common daily activities that typically require use of two hands. The child then rates the time required, the efficacy of grasp, and how bothered they feel by their hand function on the task. Total score transformed by a Rasch analysis into a scale of 0-100 units (better score means better outcome).	Measured one week post-intervention.
Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)	CHEQ is a 29 item child-completed questionnaire that examines how the weaker/affected limb is used in everyday activities. It presents a list of common daily activities that typically require use of two hands. The child then rates the time required, the efficacy of grasp, and how bothered they feel by their hand function on the task. Total score transformed by a Rasch analysis into a scale of 0-100 units (better score means better outcome).	Measured 6-month post-intervention.
Self-assessments - Canadian Occupational Performance Measure (COPM)	Prior to the intervention, children, parents and therapists will work together to set a therapy goal related to their hand or wrist function. The child will score their current performance/satisfaction on the identified activity and will re-score post-intervention. Performance: scale from 0 to 10, better the score is better is the outcome. Satisfaction: scale from 0 to 10, better the score is better is the outcome.	Measured prior to the intervention.
Self-assessments - Canadian Occupational Performance Measure (COPM)	Prior to the intervention, children, parents and therapists will work together to set a therapy goal related to their hand or wrist function. The child will score their current performance/satisfaction on the identified activity and will re-score post-intervention.Performance: scale from 0 to 10, better the score is better is the outcome. Satisfaction: scale from 0 to 10, better the score is better is the outcome.	Measured one week post-intervention.
Self-assessments - Canadian Occupational Performance Measure (COPM)	Prior to the intervention, children, parents and therapists will work together to set a therapy goal related to their hand or wrist function. The child will score their current performance/satisfaction on the identified activity and will re-score post-intervention. Performance: scale from 0 to 10, better the score is better is the outcome. Satisfaction: scale from 0 to 10, better the score is better is the outcome.	Measured 6-month post-intervention.

Collaborators and Investigators

• Sponsor: Laval University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Anticipated): January 30, 2027
• Study Completion (Anticipated): January 30, 2027

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Accelerometry; Intensive bimanual therapy; Upper limb motor function; Motor learning
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Manœuvre

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No