NCT04483388

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
5 years until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
Last Updated

July 23, 2020

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

August 11, 2015

Last Update Submit

July 20, 2020

Conditions

Keywords

Cerebral PalsyRehabilitationPhysiotherapyVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 months

Study Arms (2)

Group AB

OTHER

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.

Other: Training with Virtual RealityOther: Conventional Training

Group BA

OTHER

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.

Other: Training with Virtual RealityOther: Conventional Training

Interventions

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.

Also known as: Training A
Group ABGroup BA

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).

Also known as: Training B
Group ABGroup BA

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 12509602BACKGROUND
  • 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.

    PMID: 16108461BACKGROUND
  • 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.

    PMID: 12227614BACKGROUND
  • 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.

    PMID: 23583864BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ana Raquel Lindquist, PhD

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 11, 2015

First Posted

July 23, 2020

Study Start

June 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 23, 2020

Record last verified: 2015-02