Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05423171

Intensive Bimanual Intervention in Cerebral Palsy Children

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensive bimanual therapy

Other

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

Primary outcomes

  1. Magnetic Resonance Imaging (MRI)

    Time frame: Measured prior to the intervention.

    Neurophysiological evaluation

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Robotic evaluation - Arm-position matching

    Time frame: Measured prior to the intervention.

    In this proprioception task the sense of upper limb position is evaluated

  12. Robotic evaluation - Arm-position matching

    Time frame: Measured one week post-intervention.

    In this proprioception task the sense of upper limb position is evaluated

  13. Robotic evaluation - Arm-position matching

    Time frame: Measured 6-month post-intervention.

    In this proprioception task the sense of upper limb position is evaluated

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Clinical evaluation -Two-point discrimination test (TPDT)

    Time frame: Measured prior to the intervention.

    Sensitive test to determine tactile threshold

  19. Clinical evaluation -Two-point discrimination test (TPDT)

    Time frame: Measured one week post-intervention.

    Sensitive test to determine tactile threshold

  20. Clinical evaluation -Two-point discrimination test (TPDT)

    Time frame: Measured 6-month post-intervention.

    Sensitive test to determine tactile threshold.

  21. 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.

  22. 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.

  23. Clinical evaluation - Jebsen Taylor Test of Hand Function (JTTHF)

    Time frame: Measured 6-month post-intervention.

    Seven standardized tasks to evaluate the unimanual function

  24. 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.

  25. 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.

  26. 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.

  27. 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).

  28. 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).

  29. 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).

  30. 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).

  31. 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).

  32. 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).

  33. 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).

  34. 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).

  35. 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).

Secondary outcomes

  1. Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)

    Time frame: Measured prior to the intervention.

    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).

  2. Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)

    Time frame: Measured one week post-intervention.

    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).

  3. Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)

    Time frame: Measured 6-month post-intervention.

    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).

  4. Self-assessments - Canadian Occupational Performance Measure (COPM)

    Time frame: Measured prior to the intervention.

    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.

  5. Self-assessments - Canadian Occupational Performance Measure (COPM)

    Time frame: Measured one week post-intervention.

    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.

  6. Self-assessments - Canadian Occupational Performance Measure (COPM)

    Time frame: Measured 6-month post-intervention.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Mercier, PhD;OT

CONTACT

[email protected]

141852991416701

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 21, 2022
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.