Intensive Bimanual Intervention in Cerebral Palsy Children

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05423171
• Other study ID #: Manœuvre
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: January 30, 2027

Study information

• Verified date: June 2022
• Source: Laval University
• Contact: Catherine Mercier, PhD;OT
• Phone: 141852991416701
• Email: catherine.mercier[@]rea.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 30, 2027
• Est. primary completion date: January 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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

Locations

Country	Name	City	State
Canada	Université Laval	Québec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetic Resonance Imaging (MRI)	Neurophysiological evaluation	Measured prior to the intervention.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Robotic evaluation - Arm-position matching	In this proprioception task the sense of upper limb position is evaluated	Measured prior to the intervention.
Primary	Robotic evaluation - Arm-position matching	In this proprioception task the sense of upper limb position is evaluated	Measured one week post-intervention.
Primary	Robotic evaluation - Arm-position matching	In this proprioception task the sense of upper limb position is evaluated	Measured 6-month post-intervention.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Clinical evaluation -Two-point discrimination test (TPDT)	Sensitive test to determine tactile threshold	Measured prior to the intervention.
Primary	Clinical evaluation -Two-point discrimination test (TPDT)	Sensitive test to determine tactile threshold	Measured one week post-intervention.
Primary	Clinical evaluation -Two-point discrimination test (TPDT)	Sensitive test to determine tactile threshold.	Measured 6-month post-intervention.
Primary	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.
Primary	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.
Primary	Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)	Seven standardized tasks to evaluate the unimanual function	Measured 6-month post-intervention.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.