Cerebral PalsyNCT05423171
Intensive Bimanual Intervention in Cerebral Palsy Children
A study testing Intensive bimanual therapy in people with Cerebral Palsy, run by Laval University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Intensive bimanual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jun 2021to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Université Laval
Québec, G1V 0A6
Mercier Catherine, Ph.D.;O.T., 141852991416701, catherine.mercier@rea.ulaval.ca
About this study
Official title: 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.
Read the 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
- Being tested
- Intensive bimanual therapy
- Keywords
- Intensive bimanual therapy, Upper limb motor function, Rehabilitation, Motor learning, Accelerometry
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive bimanual therapyOther
60-hour intensive therapy promoting the use of both hands (ex: bimanual activities, games,...)
| Study group | Role | What they receive |
|---|---|---|
| MANUS | Experimental | 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. Receives: Other: Intensive bimanual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging (MRI)
Neurophysiological evaluation
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: Measured 6-month post-intervention.
Robotic evaluation - Arm-position matching
In this proprioception task the sense of upper limb position is evaluated
Measured: Measured prior to the intervention.
Robotic evaluation - Arm-position matching
In this proprioception task the sense of upper limb position is evaluated
Measured: Measured one week post-intervention.
Robotic evaluation - Arm-position matching
In this proprioception task the sense of upper limb position is evaluated
Measured: 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: 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: 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: 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: Measured during two-days 6-month post-intervention.
Clinical evaluation -Two-point discrimination test (TPDT)
Sensitive test to determine tactile threshold
Measured: Measured prior to the intervention.
Clinical evaluation -Two-point discrimination test (TPDT)
Sensitive test to determine tactile threshold
Measured: Measured one week post-intervention.
Clinical evaluation -Two-point discrimination test (TPDT)
Sensitive test to determine tactile threshold.
Measured: 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: 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: Measured one week post-intervention.
Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)
Seven standardized tasks to evaluate the unimanual function
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Measured 6-month post-intervention.
Secondary outcomes (6)
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: 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: 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: 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: 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: 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: Measured 6-month post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start30 Jun 2021
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Mercier, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423171
- Sponsor's protocol ID
- Manœuvre
- Status last verified
- Jun 2022
- First submitted
- 25 May 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Response to an Intensive Bimanual Intervention in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05423171
- Acronym / sponsor ID
- Manœuvre
- Conditions
- Cerebral Palsy
- Keywords
- Intensive bimanual therapy, Upper limb motor function, Rehabilitation, Motor learning, Accelerometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MANUS | Experimental | Other: Intensive bimanual therapyChildren 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive bimanual therapy60-hour intensive therapy promoting the use of both hands (ex: bimanual activities, games,...) | Other | MANUS |
Primary outcome
Magnetic Resonance Imaging (MRI)
Time frame: Measured prior to the intervention.
Neurophysiological evaluation
Robotic evaluation - Visually guided reaching
Time frame: Measured prior to the intervention.
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)
Robotic evaluation - Visually guided reaching
Time frame: Measured one week post-intervention.
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)
Robotic evaluation - Visually guided reaching
Time frame: Measured 6-month post-intervention.
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)
Robotic evaluation - Object hit
Time frame: Measured prior to the intervention.
The participant must hit the balls with the hand of they choice, each successful contact generating haptic feedback.
Robotic evaluation - Object hit
Time frame: Measured one week post-intervention.
The participant must hit the balls with the hand of they choice, each successful contact generating haptic feedback.
Robotic evaluation - Object hit
Time frame: Measured 6-month post-intervention.
The participant must hit the balls with the hand of they choice, each successful contact generating haptic feedback.
Robotic evaluation - Ball on bar
Time frame: Measured prior to the intervention.
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.
Robotic evaluation - Ball on bar
Time frame: Measured one week post-intervention.
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.
Robotic evaluation - Ball on bar
Time frame: Measured 6-month post-intervention.
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.
Robotic evaluation - Arm-position matching
Time frame: Measured prior to the intervention.
In this proprioception task the sense of upper limb position is evaluated
Robotic evaluation - Arm-position matching
Time frame: Measured one week post-intervention.
In this proprioception task the sense of upper limb position is evaluated
Robotic evaluation - Arm-position matching
Time frame: Measured 6-month post-intervention.
In this proprioception task the sense of upper limb position is evaluated
Spontaneous use of both arms
Time frame: Measured during two-days prior to the intervention.
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.
Spontaneous use of both arms
Time frame: Measured two days during the intervention.
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.
Spontaneous use of both arms
Time frame: Measured during two-days one week post-intervention.
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.
Spontaneous use of both arms
Time frame: Measured during two-days 6-month post-intervention.
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.
Clinical evaluation -Two-point discrimination test (TPDT)
Time frame: Measured prior to the intervention.
Sensitive test to determine tactile threshold
Clinical evaluation -Two-point discrimination test (TPDT)
Time frame: Measured one week post-intervention.
Sensitive test to determine tactile threshold
Clinical evaluation -Two-point discrimination test (TPDT)
Time frame: Measured 6-month post-intervention.
Sensitive test to determine tactile threshold.
Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)
Time frame: Measured prior to the intervention.
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.
Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)
Time frame: Measured one week post-intervention.
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.
Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)
Time frame: Measured 6-month post-intervention.
Seven standardized tasks to evaluate the unimanual function
Clinical evaluation - Box and Blocks Test (BBT)
Time frame: Measured prior to the intervention.
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.
Clinical evaluation - Box and Blocks Test (BBT)
Time frame: Measured one week post-intervention.
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.
Clinical evaluation - Box and Blocks Test (BBT)
Time frame: Measured 6-month post-intervention.
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.
Clinical evaluation - Assisting Hand Assessment (AHA)
Time frame: Measured prior to the intervention.
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).
Clinical evaluation - Assisting Hand Assessment (AHA)
Time frame: Measured one week post-intervention.
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).
Clinical evaluation - Assisting Hand Assessment (AHA)
Time frame: Measured 6-month post-intervention.
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).
Clinical evaluation - Two-Arm Coordination Test (TACT)
Time frame: Measured prior to the intervention.
Evaluation of the constrained bilateral use of both upper limbs with an electronic tracking device (eight tests; four clockwise and four counter-clockwise).
Clinical evaluation - Two-Arm Coordination Test (TACT)
Time frame: Measured one week post-intervention.
Evaluation of the constrained bilateral use of both upper limbs with an electronic tracking device (eight tests; four clockwise and four counter-clockwise).
Clinical evaluation - Two-Arm Coordination Test (TACT)
Time frame: Measured 6-month post-intervention.
Evaluation of the constrained bilateral use of both upper limbs with an electronic tracking device (eight tests; four clockwise and four counter-clockwise).
Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R)
Time frame: Measured prior to the intervention.
Visual perception test that assesses consistency of form, spatial orientation, discrimination, memory and visual closure (Score: 0 - 40; better score means better outcome).
Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R)
Time frame: Measured one week post-intervention.
Visual perception test that assesses consistency of form, spatial orientation, discrimination, memory and visual closure (Score: 0 - 40; better score means better outcome).
Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R)
Time frame: Measured 6-month post-intervention.
Visual perception test that assesses consistency of form, spatial orientation, discrimination, memory and visual closure (Score: 0 - 40; better score means better outcome).
6 secondary outcomes
Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)
Time frame: Measured prior to the intervention.
Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)
Time frame: Measured one week post-intervention.
Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)
Time frame: Measured 6-month post-intervention.
Self-assessments - Canadian Occupational Performance Measure (COPM)
Time frame: Measured prior to the intervention.
Self-assessments - Canadian Occupational Performance Measure (COPM)
Time frame: Measured one week post-intervention.
Self-assessments - Canadian Occupational Performance Measure (COPM)
Time frame: Measured 6-month post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive bimanual therapy in people with Cerebral Palsy, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Mercier, PhD;OT (141852991416701, catherine.mercier@rea.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging (MRI) (time frame: Measured prior to the intervention.). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.