Clinical Trial: Evidence-Based Neurorehabilitation in Children With CP

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparative Efficacy Research of Intensive and Distributed Constraint-Induced Therapy: Evidence-Based Neurorehabilitation in Children With CP

Brief Summary: This 3-year research project aims to investigate and compare the treatment effectiveness (in terms of motor and psychosocial outcomes) and potential predictors (in terms of demographical, biological and psychosocial domains) of the intensive and distributed Child- and Family-Friendly CIT protocols with an equivalent intervention period in children with CP by cross-over study design. In addition, the selection and examination of outcome measures were based on the ICF-CY model to provide comprehensively documents.

Detailed Summary:

Upper limb dysfunction is a common and disabling consequence of children with cerebral palsy (CP). As children with hemiplegia primarily have one better funcitoning side of their body and one more affected side, they often tend not to use the affected extremity resulting in the phenoema of developmental disregard. Recent evidence suggests that constraint-induced therapy (CIT) is the most effective technique to improve the use of the affected hand and reduce the developmental disregard in children with CP. However, despite the cumulative evidence supporting the effects of pediatric CIT, the concerns of feasibility and gaps of current knowledge prompt us to conduct this current proposal. The concerns of the feasibility include this approach is emotionally problematic at early stages and researchers suggested that the orginal CIT protocols may be too intrusive for children and their families. The gaps of current knowledge include: no study has directly investigated the effectiveness differences between various CIT models; no study examines, monitors and compares the psychosocial outcomes while receiving the CIT protocols for children and their parents systematically and comprehensively; and no study investigates the possible clinical characteristics of children that may influence the training effects of the various CIT models.

Investigators will recruit a total of 60 children with CP from the CP Association, medical centers, and special educational systems and participants will be randomly assigned to the two intervention groups. The intensive CIT is delivered by the group-based design with 6 hours a day for 6 days (36 hours in total) and the distributed CIT will be delivered by individualized home-based intervention with 2.25 hours a day, two times a week, for 8 weeks (36 hours in total).


Sponsor: National Taiwan University Hospital

Current Primary Outcome:

  • "change" Melbourne Assessment 2 (MA2) [ Time Frame: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months ]
    The MA2 was developed to investigate the objective upper-limb movement in children with CP aged 2.5 to 15 years (Randall, Imms, Carey, & Pallant, 2014). The test comprises 14 functional tasks (e.g., grasping a pellet, pointing, and etc), which are representative of the most important components of unilateral upper limb function, including reach, grasp, release, and manipulate.
  • "change" Box and Block Test (BBT) [ Time Frame: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months ]
    The BBT assesses manual dexterity by county the number of blocks that are transferred with a single hand from one compartment to another within 60 seconds. In recent years, it has increasingly been used to assess gross manual dexterity of the affected versus the non-affected hand in children and young adolescents with hemiplegia cerebral palsy.
  • "change" Pediatric Motor Activity Log-Revised (PMAL-R) [ Time Frame: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months ]
    The PMAL-R is adapted from the Pediatric Motor Activity Log (Taub et al., 2004), which was developed as an outcome measure for evaluating the effectiveness of CIT in children with CP. It is a parent-reported evaluative tool used to capture the spontaneous use of the affected upper limb in 22 da

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • "change" Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) [ Time Frame: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months ]
      The BOT-2 is widely used as an efficient and standardized measurement of motor control skills for children aged 4 through 21. The subtest 3 of the BOT-2, manual dexterity (MD), will be used to assess a child's upper limb dexterity. The subtests 3 of the BOT-2 consist of 5 goal-directed activities that involve reaching, grasping, and bimanual coordination with small objects to investigate a child's upper limb manual function
    • "change" Motion Analysis [ Time Frame: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months ]
      For the performance outcome measures, endpoint variables during reach-to-grasp task, namely reaction time, movement time, movement unit, peak velocity and its time percentage during the movement time will be calculated using the wrist marker. For the performance production measures, joint angles of the shoulder, elbow and wrist during reach-to-grasp task will also be calculated to represent the motor strategy of children with CP before and after intervention.
    • "change" ABILHAND-Kids [ Time Frame: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months ]
      The ABILHAND-Kids questionnaire is a Rasch-based assessment that measures children's perceived difficulty in performing ADL that require the use of the bilateral upper limbs. It contains 21 items measuring manual ability and is rated on a 3-point response scale. The parent is asked to fill in the questionnaire by estimating their child's ease or difficulty in performing each activity, irrespective of the limb(s) the child actually use and whatever the strategies used to perform the activity.
    • "change" Pediatric Evaluation of Disability Inventory (PEDI) [ Time Frame: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months ]
      The PEDI is used to evaluate the generalization of treatment effect to daily life. The PEDI assesses the level of independence in daily activities in children with cerebral palsy, including the functional performance and level of assistance needed in daily activities.
    • "change" Dimensions of Mastery Questionnaire (DMQ) [ Time Frame: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months ]
      The DMQ provides a primary caregiver's perceptions of mastery motivation. It consists of 45 items across seven subscales and two aspects of mastery motivation. Instrumental mastery focuses on persistence with tasks and includes the subscales of object-oriented persistence, gross motor persistence, social persistence with adults and social persistence with peers. Expressive mastery comprises subscales of negative reactions to failure and mastery pleasure. The final subscale, competence, is considered a separate construct which measures the child's ability to master tasks relative to peers. This involves rating each of the 45 items on a five-point scale ranging from 1=not at all typical to 5=very typical.
    • "change" Test of Playfulness (ToP) [ Time Frame: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months ]
      The ToP is an assessment designed for measuring the playfulness of individuals between the ages 6 months and 18 years. It is composed of 24 items that are scored following an observation of the individual's free play. Items are scored on a 4-point Likert scale with respect to three dimensions: Extent (0 = rarely or never, 3 = almost always), Intensity (0 = not, 3 = highly), and Skillfulness (0 = unskilled, 3 = highly skilled).
    • "change" Pediatric Engagement Questionnaire (PEQ) [ Time Frame: Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months ]
      The PEO includes two versions, that is, child version and therapist version (PEQ-C, PEQ-T). The items of the PEQ are modified from existing questionnaires Pediatric Motivation Scale (PMOT) and based on tenets of self-determination theory. The PEQ-C consists 16 items by 5-point Likert scale with smiley face figures. It is an event-based measurement of motivation and is designed to measure motivation and the experience of receiving specific therapeutic activities. The PEQ-T represents therapists' observations of the child's engagement, participation, and persistence of master the tasks during interventions sessions. It is also designed as 5-point Likert scale on child's engagement, participation, and task persistence for therapists' points of view.
    • "change" Client Satisfaction Questionnaire (CSQ) [ Time Frame: Int

      Original Secondary Outcome: Same as current

      Information By: National Taiwan University Hospital

      Dates:
      Date Received: April 18, 2017
      Date Started: June 1, 2017
      Date Completion: December 2020
      Last Updated: April 20, 2017
      Last Verified: March 2017