Intensive Bimanual Intervention in Cerebral Palsy Children

NCT05423171 | Recruiting

• 1 other identifier: Manœuvre
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy

Keywords

Intensive bimanual therapy; Upper limb motor function; Rehabilitation; Motor learning; Accelerometry

Outcome Measures

Primary Outcomes (35)

• 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 Outcomes (6)

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

  Measured prior to the intervention.

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

  Measured one week post-intervention.

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

  Measured 6-month post-intervention.

• Self-assessments - Canadian Occupational Performance Measure (COPM)

  Measured prior to the intervention.

• Self-assessments - Canadian Occupational Performance Measure (COPM)

  Measured one week post-intervention.

Study Arms (1)

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.

Other: Intensive bimanual therapy

Interventions

Intensive bimanual therapy OTHER

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

MANUS

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• , 2 or 3);
• Having cognitive capacities to understand and perform task of the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Université Laval

Québec, G1V 0A6, Canada

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Catherine Mercier, PhD;OT

CONTACT

141852991416701; catherine.mercier@rea.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Université Laval, Scientific Director, Cirris

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 21, 2022
• Study Start: June 30, 2021
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

CA (1)