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临床试验/NCT05423171
NCT05423171招募中不适用

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

Laval University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Clinical evaluation - Two-Arm Coordination Test (TACT)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Clinical evaluation - Two-Arm Coordination Test (TACT)

时间窗: 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).

Robotic evaluation - Arm-position matching

时间窗: Measured 6-month post-intervention.

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

Clinical evaluation - Box and Blocks Test (BBT)

时间窗: 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.

Magnetic Resonance Imaging (MRI)

时间窗: Measured prior to the intervention.

Neurophysiological evaluation

Robotic evaluation - Visually guided reaching

时间窗: 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

时间窗: Measured 6-month post-intervention.

The participant must hit the balls with the hand of they choice, each successful contact generating haptic feedback.

Spontaneous use of both arms

时间窗: 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)

时间窗: Measured 6-month post-intervention.

Sensitive test to determine tactile threshold.

Clinical evaluation - Motor-Free Visual Perception Test-Revised (MVPT-R)

时间窗: 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).

Robotic evaluation - Ball on bar

时间窗: 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.

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

时间窗: Measured 6-month post-intervention.

Seven standardized tasks to evaluate the unimanual function

Clinical evaluation - Assisting Hand Assessment (AHA)

时间窗: 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).

次要结局

  • Self-assessments - Canadian Occupational Performance Measure (COPM)(Measured 6-month post-intervention.)
  • Self-assessments - Children's Hand-use Experience Questionnaire (CHEQ)(Measured 6-month post-intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Mercier

Full Professor, Université Laval, Scientific Director, Cirris

Laval University

研究点 (2)

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