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Training With Virtual Reality in Upper Arm Reaching of Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training with Virtual Reality
Conventional Training
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Rehabilitation, Physiotherapy, Virtual Reality

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A diagnosis of cerebral palsy spastic hemiparesis;
  • Aged 6 to 12 years old;
  • Preserved cognition to understand instructions;
  • Present no significant auditory and visual deficits;
  • The affected upper limb classified in levels II and III Rating System Manual (MACS, English Manual Abilities Classification System). The level II corresponds to children who are able to handle the majority of objects with low quality and / or speed of movement, while at level III are those that manipulate objects with difficulty and low speed, requiring assistance organization of activity. Spasticity ranked among the levels 0 and 3 of the Modified Scale Ashworth.It has not performed orthopedic surgeries, or have made use of botulinum toxin for less than six months, not presenting seizures, controlled medication.

Exclusion Criteria:

  • Presence of pain or discomfort during the course of the training;
  • Refusal to follow commands and instructions and discontinuity of interventions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Group AB

    Group BA

    Arm Description

    After randomization, 6 children composed the AB sequence were initially submitted to experimental training with virtual reality and after a week, a period considered washout, the conventional training.

    After randomization 6 children composed the BA sequence were initially submitted to conventional training and after a week, a period considered washout, the experimental training with virtual reality.

    Outcomes

    Primary Outcome Measures

    Kinematic upper arm evaluation of children with cerebral palsy
    We used a standardized 3D-analysis protocol to evaluate upper limb kinematic. The evaluation was divided into two stages: static collection and dynamics. In static collection, the patient was seated on a bench with feet on the floor, so that a 90 ° angle hip, knee and ankle joints. A table was positioned at a distance of 100% of the length of the affected upper arm and at the height of the xiphoid process and were used 19 mm reflective markers at the following points anatomical. In the dynamic evaluation, the participant continued to sit on the bench, with arms at the side of the torso, maintaining 90 ° elbow flexion and hand on the table was asked to touch a cube. All children started reach movement with the unaffected limb. Therefore, 15 reaches per child in each member in total and it was performed one minute intervals between attempts. The following variables: duration of movement, peak velocity and angular variation of shoulder and elbow.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 11, 2015
    Last Updated
    July 20, 2020
    Sponsor
    Universidade Federal do Rio Grande do Norte
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04483388
    Brief Title
    Training With Virtual Reality in Upper Arm Reaching of Children With Cerebral Palsy
    Official Title
    Training With Virtual Reality in Upper Arm Reaching of Children With Cerebral Palsy: Crossover Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio Grande do Norte

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of this study was to evaluate the effects of training with Virtual Reality in the movement range of children with Cerebral Palsy spastic hemiparetic.The study protocol consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol) were randomized the children in AB and BA sequences, with one week interval. Immediately kinematics pre and post-training was held and after a week no significant changes were observed for the angular variables and space-time between groups. The Virtual Reality used for intervention to improve upper arm function in children with Cerebral Palsy is still a relatively new method.
    Detailed Description
    Introduction: The disability of upper limb function (MS) of children with Cerebral Palsy (CP) spastic hemiparetic restricts their participation in social activities. Virtual reality (VR) has shown promising results in functional recovery of this population, however, few studies have evaluated its effectiveness in the reaching of motion of these children. Objective: To assess the effects of training with VR in the movement range of children with CP spastic hemiparetic. Materials and Methods: We conducted a randomized crossover trial, where the sample consisted of 12 children diagnosed with CP hemiparetic, both genders, with a mean age of 9.63 ± 2.3 years. The sample description was performed by assessing muscle tone, range of motion, grip strength, functional performance and disability. Kinematic analysis of the upper limb was performed by Qualisys Motion Capture System®. The study protocol consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol) were randomized the children in AB and BA sequences, with one week interval. Immediately kinematics pre and post-training was held and after a week. Data were analyzed using SPSS 20.0 (Statistical Package for Social Science) assigning a 5% significance level. The kinematic variables were analyzed by two-way ANOVA for repeated measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy
    Keywords
    Cerebral Palsy, Rehabilitation, Physiotherapy, Virtual Reality

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group AB
    Arm Type
    Other
    Arm Description
    After randomization, 6 children composed the AB sequence were initially submitted to experimental training with virtual reality and after a week, a period considered washout, the conventional training.
    Arm Title
    Group BA
    Arm Type
    Other
    Arm Description
    After randomization 6 children composed the BA sequence were initially submitted to conventional training and after a week, a period considered washout, the experimental training with virtual reality.
    Intervention Type
    Other
    Intervention Name(s)
    Training with Virtual Reality
    Other Intervention Name(s)
    Training A
    Intervention Description
    Computed virtual reality therapy was performed using the Nintendo Wii® console equipment. This system allows interaction with the player by means of a movement detection system and the representation of his avatar graphical representation of a user in virtual reality. It has a remote control with a wireless system, responsible for capturing the speed, direction , acceleration and deceleration of movement. The movements performed by the player are captured and reproduced on a screen via an infrared light sensor, positioned above the TV. The feedback given by the TV provides the movement itself observing opportunity in real time, generating positive reinforcement and facilitating training and improved task. The software used in this study was the Nintendo Wii Sports.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional Training
    Other Intervention Name(s)
    Training B
    Intervention Description
    It was done five types of exercises following to the protocol: Exercise 1 (shoulder abduction); Exercise 2 (external rotation of the shoulder); Exercise 3 (elbow extension); Exercise 4 (weight transfer in upper limbs: a sitting position); Exercise 5 (function: task-oriented training).
    Primary Outcome Measure Information:
    Title
    Kinematic upper arm evaluation of children with cerebral palsy
    Description
    We used a standardized 3D-analysis protocol to evaluate upper limb kinematic. The evaluation was divided into two stages: static collection and dynamics. In static collection, the patient was seated on a bench with feet on the floor, so that a 90 ° angle hip, knee and ankle joints. A table was positioned at a distance of 100% of the length of the affected upper arm and at the height of the xiphoid process and were used 19 mm reflective markers at the following points anatomical. In the dynamic evaluation, the participant continued to sit on the bench, with arms at the side of the torso, maintaining 90 ° elbow flexion and hand on the table was asked to touch a cube. All children started reach movement with the unaffected limb. Therefore, 15 reaches per child in each member in total and it was performed one minute intervals between attempts. The following variables: duration of movement, peak velocity and angular variation of shoulder and elbow.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A diagnosis of cerebral palsy spastic hemiparesis; Aged 6 to 12 years old; Preserved cognition to understand instructions; Present no significant auditory and visual deficits; The affected upper limb classified in levels II and III Rating System Manual (MACS, English Manual Abilities Classification System). The level II corresponds to children who are able to handle the majority of objects with low quality and / or speed of movement, while at level III are those that manipulate objects with difficulty and low speed, requiring assistance organization of activity. Spasticity ranked among the levels 0 and 3 of the Modified Scale Ashworth.It has not performed orthopedic surgeries, or have made use of botulinum toxin for less than six months, not presenting seizures, controlled medication. Exclusion Criteria: Presence of pain or discomfort during the course of the training; Refusal to follow commands and instructions and discontinuity of interventions.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana Raquel Lindquist, PhD
    Organizational Affiliation
    Universidade Federal do Rio Grande do Norte
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12509602
    Citation
    Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89.
    Results Reference
    background
    PubMed Identifier
    16108461
    Citation
    Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
    Results Reference
    background
    PubMed Identifier
    12227614
    Citation
    Siebes RC, Wijnroks L, Vermeer A. Qualitative analysis of therapeutic motor intervention programmes for children with cerebral palsy: an update. Dev Med Child Neurol. 2002 Sep;44(9):593-603. doi: 10.1017/s0012162201002638.
    Results Reference
    background
    PubMed Identifier
    23583864
    Citation
    Coleman A, Weir KA, Ware RS, Boyd RN. Relationship between communication skills and gross motor function in preschool-aged children with cerebral palsy. Arch Phys Med Rehabil. 2013 Nov;94(11):2210-7. doi: 10.1016/j.apmr.2013.03.025. Epub 2013 Apr 11.
    Results Reference
    background
    PubMed Identifier
    23433275
    Citation
    Wu WC, Hung JW, Tseng CY, Huang YC. Group constraint-induced movement therapy for children with hemiplegic cerebral palsy: a pilot study. Am J Occup Ther. 2013 Mar-Apr;67(2):201-8. doi: 10.5014/ajot.2013.004374.
    Results Reference
    result
    PubMed Identifier
    17895352
    Citation
    Chen YP, Kang LJ, Chuang TY, Doong JL, Lee SJ, Tsai MW, Jeng SF, Sung WH. Use of virtual reality to improve upper-extremity control in children with cerebral palsy: a single-subject design. Phys Ther. 2007 Nov;87(11):1441-57. doi: 10.2522/ptj.20060062. Epub 2007 Sep 25.
    Results Reference
    result
    PubMed Identifier
    24849793
    Citation
    Chiu HC, Ada L, Lee HM. Upper limb training using Wii Sports Resort for children with hemiplegic cerebral palsy: a randomized, single-blind trial. Clin Rehabil. 2014 Oct;28(10):1015-24. doi: 10.1177/0269215514533709. Epub 2014 May 21.
    Results Reference
    result
    PubMed Identifier
    24819682
    Citation
    Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046.
    Results Reference
    result

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    Training With Virtual Reality in Upper Arm Reaching of Children With Cerebral Palsy

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