An interventional study of Intensive bimanual therapy in Cerebral Palsy, sponsored by Laval University. Recruiting at 1 site in Canada. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-06-21.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
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.
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.
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's planned enrollment of 30 is close to the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
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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);
Exclusion Criteria:
N.B. Having a ferromagnetic implant is not an exclusion criterion, such participant will be eligible but will not perform the MRI.
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,...)
Magnetic Resonance Imaging (MRI)
Neurophysiological evaluation
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured 6-month post-intervention.
Robotic evaluation - Arm-position matching
In this proprioception task the sense of upper limb position is evaluated
Time frame: Measured prior to the intervention.
Robotic evaluation - Arm-position matching
In this proprioception task the sense of upper limb position is evaluated
Time frame: Measured one week post-intervention.
Robotic evaluation - Arm-position matching
In this proprioception task the sense of upper limb position is evaluated
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured during two-days 6-month post-intervention.
Clinical evaluation -Two-point discrimination test (TPDT)
Sensitive test to determine tactile threshold
Time frame: Measured prior to the intervention.
Clinical evaluation -Two-point discrimination test (TPDT)
Sensitive test to determine tactile threshold
Time frame: Measured one week post-intervention.
Clinical evaluation -Two-point discrimination test (TPDT)
Sensitive test to determine tactile threshold.
Time frame: 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.
Time frame: 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.
Time frame: Measured one week post-intervention.
Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)
Seven standardized tasks to evaluate the unimanual function
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Measured 6-month 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured 6-month post-intervention.
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