Action Observation Based Rehabilitation of Children With Unilateral Cerebral Palsy

Sponsor
University of Parma (Other)
Overall Status
Recruiting
CT.gov ID
NCT04088994
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
29.9
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Recent evidence suggested that Action Observation Therapy (AOT), based on observation of actions followed by immediate reproduction, could be a useful rehabilitative strategy for promoting functional recovery of children affected by Unilateral Cerebral Palsy (UCP).

The AOT is based on the discovery of mirror neurons, a class of visuomotor neurons that are activated when the individual performs a targeted action, both when observing the same action performed by another individual.

An important assumption of AOT is that the mirror system, thanks to its visuomotor properties, is able to coordinate visual information with the observer's motor experience. Indeed, the actions outside the individual's behavioral repertoire are elaborated and categorized only on the basis of visual characteristics, without inducing any phenomenon of motor resonance in the observer's brain.

Therefore, given the deficiency of their motor repertoire, children affected by UCP could have a reduced activation of the mirror system during the observation of actions performed by healthy subjects. Nevertheless, this activation could increase during the observation of the same actions performed by a subject with similar motor strategies, due to a similar form of hemiplegia.

The present project is a randomized controlled clinical trial to verify the influence of the observed model on the effectiveness of AOT in the rehabilitation of the affected upper limb in children with UCP. In particular, the study will verify whether the rehabilitation through AOT based on a pathological model (improving the patient's current abilities) gives more results than AOT based on a typical (healthy) development model, as reported by all the documented researches in literature.

Furthermore, to investigate the functional reorganization of the sensorimotor system after rehabilitative treatment, a subgroup of participants will be subjected to a fMRI session (Functional Magnetic Resonance), to verify functional changes, comparing data before and after AOT.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: AOT Pathological Model Experimental Group
  • Other: AOT Healthy Model Control Group
N/A

Detailed Description

The study will compare two rehabilitation models through AOT to assess feasibility and effectiveness. In the preliminary phase of the study a single rehabilitation treatment protocol will be planned, based on the observation and execution of unimanual and bimanual actions integrated in activities that are significant for the subject's age group. The recorded actions will be performed by a child with typical development and by two hemiplegic children:

  1. upper limb disability with grades between 4-5 according to House Functional Classification (HFC) system (corresponding to synergic hand of Ferrari and Cioni's Kinematic Hand Classification).

  2. upper limb disability with grades between 6-7 according to HFC system (corresponding to subfunctional hand of Ferrari and Cioni's Kinematic Hand Classification).

The participants (N. 26) randomly assigned to the experimental group will be subjected to the rehabilitation protocol through AOT based on the observation of the "Pathological Model". The model, while showing a manipulation strategy similar to that of the study participant, will show an improvement with respect to the patient's current abilities. The children randomly assigned to the control group will be subjected to the rehabilitation treatment protocol through AOT based on the "Typical developmental model".

Both experimental and control treatment will consist of a minimum of 10 hours (min. 10, max 15) for a period of 15 consecutive working days (3 weeks). Each video sequence will show a specific action repeated several times for 3 minutes. Subsequently, participants will be asked to perform the action observed with their hemiplegic upper limb or with both upper limbs for a maximum of 3 repetitions.

A subgroup of study participants (N. 8+8) from both groups will undergo two fMRI sessions, before and immediately after the AOT.

The fMRI session consists of two experimental tasks:
  1. action observation (functional session 1-2), in which patients will observe short videos in which actions are performed with the right hand from a subjective perspective.

  2. motor task (session 3), in which actions consist in reaching-grasping an object (a cube, a sphere or a cylinder) and putting it into boxes, placed on the right and on the left of the object.

The study consists of two experimental conditions:
  1. Observation of the paretic hand, in which the actions will be performed by another patient with UCP.

  2. Observation of the healthy hand, in which the action will be reproduced by a healthy model.

The aim of the study is to investigate the functional reorganization of sensorimotor system comparing functional activation before and after rehabilitation with AOT.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled experimental study, with 1:1 allocation ratio and two-armed blind assessment. Randomization will be stratified by age and level of HFC system to obtain two groups balanced with respect to the level of functional impairment of the upper limbs to be subjected to treatment in the two groups. Clinical evaluations will be performed before treatment (T0), at the end of treatment (T1), from 8 to 12 weeks after the end of treatment (T2) and finally, from 24 to 28 weeks after the end of treatment (T3). Evaluation by fMRI will be performed at T0 and T1.Randomized controlled experimental study, with 1:1 allocation ratio and two-armed blind assessment. Randomization will be stratified by age and level of HFC system to obtain two groups balanced with respect to the level of functional impairment of the upper limbs to be subjected to treatment in the two groups. Clinical evaluations will be performed before treatment (T0), at the end of treatment (T1), from 8 to 12 weeks after the end of treatment (T2) and finally, from 24 to 28 weeks after the end of treatment (T3). Evaluation by fMRI will be performed at T0 and T1.
Masking:
Single (Outcomes Assessor)
Masking Description:
Single
Primary Purpose:
Treatment
Official Title:
Rehabilitation of Hemiplegic Cerebral Palsy Children: Role of Motor Activity and Action Observation Therapy in the Recovery of the Affected Upper Limb
Actual Study Start Date :
Dec 3, 2019
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: pathological model

The children assigned to the experimental group will participate in a rehabilitative protocol based on the AOT observing unimanual and bimanual actions performed by a model with a similar manipulation strategy but improved with respect to the child's current abilities.

Other: AOT Pathological Model Experimental Group
The children will participate in a rehabilitation intervention based on the observation of unimanual and bimanual actions performed by a model with the same degree of motor impairment, but an improvement on the participant's current abilities.
Other Names:
  • Pathological Model
  • Active Comparator: Healthy model

    The children assigned to the control group will participate in a rehabilitative protocol based on the AOT observing unimanual and bimanual actions performed by a healthy model

    Other: AOT Healthy Model Control Group
    The children assigned to the healthy group will participate in a rehabilitative protocol based on the AOT observing unimanual and bimanual actions performed by a healthy model
    Other Names:
  • Healthy Model
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Assisting Hand Assessment (AHA) [Change from baseline (T0) AHA score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.]

      The AHA measures the effectiveness with which a child with unilateral upper limb disabilities use their affected hand in the bimanual activity with a total raw score range between 22-88 points (the rating scale categories is: 4=effective, 3=somewhat effective, 2=ineffective, and 1=does not do). The higher score indicating higher ability.

    Secondary Outcome Measures

    1. Change in Melbourne Assessment of Unilateral Upper Limb Function (MUUL) [Change from baseline (T0) MUUL score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.]

      MUUL is a measure of the unilateral upper limb function. It consists of 16 items that include: reaching, grasping, releasing, manipulating, which estimates 4 domains of movement quality (range, accuracy, fluidity, dexterity). A score from 0 to 3 or 4 is assigned for each domain. Higher scores are associated with better performances.

    2. Change in Ability Hand Kids questionnaire (ABILHAND-Kids) [Change from baseline (T0) ABILHAND-Kids score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.]

      The ABILHAND-Kids is a measure of bimanual performance in activities of daily living.The scale measures a person's ability to manage daily activities that require the use of the upper limbs.The total score based on 21 activities. The parent is asked to rate his/her perception on the response scale as "Impossible", "Difficult" or "Easy" (0 = "Impossible", 1 = "Difficult" or 2 = "Easy").The total score based on 21 activities is then converted into a linear measure of manual ability (logits).

    3. Change in Activities Scale for Kids-Performance Version (ASKp) [Change from baseline (T0) ASKp score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.]

      The ASKp measure physical function and disability in children with musculoskeletal disorders based on their perspective of what they have been doing at home, at school, and on the playground. ASKp is a child self-report questionnaire, which can be parent-reported if necessary. Scale ranges from 0 to 100 with higher scores representing more physical activity.

    4. Change from baseline of functional magnetic resonance imaging (fMRI) analysis [Baseline (T0), T1 (at the end of the 3 weeks of treatment)]

      fMRI action observation task

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • confirmed diagnosis of UCP according to definition (MRI and clinical history)

    • age 6-16 years at the time of recruitment;

    • mild or moderate disability of the upper limb: score between 4 and 7 according to the House Functional Classification (HFC) system;

    • sufficient cooperation and understanding to participate in the activities, according to the doctor/physiotherapist who is treating the child and to the neuropsychological evaluation.

    Exclusion Criteria:
    • cognitive, visual or auditory impairments;

    • history of seizures or seizures not well controlled by therapy;

    • upper limb surgery within 8 months prior to enrollment;

    • upper limb botulinum toxin injection (BoNT-A) within 6 months prior to enrollment.

    Additional exclusion criteria for participants in fMRI sessions:
    • insufficient cooperation to participation in neuroimaging studies lasting about 30 minutes;

    • presence of contraindications to instrumental investigations using 3 Tesla Magnetic Resonance system (implants, metal prostheses, shunts etc.). The presence of these contraindications will be verified by the use of a preliminary questionnaire administered to the parents.

    • < 9 years at the time of recruitment.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1IRCCS S. Maria Nuova Hospital - Rehabilitation unit for severe disabilities in the developmental ageReggio EmiliaItaly42123

    Sponsors and Collaborators

    • University of Parma

    Investigators

    • Principal Investigator: Leonardo Fogassi, PhD, University of Parma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Parma
    ClinicalTrials.gov Identifier:
    NCT04088994
    Other Study ID Numbers:
    • CEREBRALPALSYc1
    First Posted:
    Sep 13, 2019
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Parma
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2021