Impact of training with video games in a population of children and adolescents with motor disabilities

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-3sc9zc
• Date of registration: 07/12/2015
• Prospective Registration: No
• Primary sponsor: Universidad de Talca
• Public title: Impact of training with video games in a population of children and adolescents with motor disabilities
• Scientific title: Impact of virtual reality training in a population of children and adolescents with cerebral palsy - not applicable: not applicable
• Date of first enrolment: 13/08/2012
• Recruitment status: Data analysis completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-3sc9zc
• Study type: Intervention
• Study design: Clinical trial treatment, randomized-controlled, parallel, open, with two arms
• Phase: N/A

Countries of recruitment

Chile

Contacts

• Name: Valeska Gatica Rojas
• Affiliation: Universidad de Talca

• Name: Mauricio Hidalgo Ríos
• Affiliation: Fondo Nacional de Investigación y Desarrollo en Salud (FONIS)

Key inclusion & exclusion criteria

Inclusion criteria: Participants with cerebral palsy type spastic diplegia and hemiplegia (male and female); 7-14 years old; Gross Motor Function Classification System (GMFCS) level I and II y volunteers with informed consent and assent

Exclusion criteria: Neurodegenerative diseases & vestibular disorders; mdministration of high and/or moderate doses of anticonvulsants or similar drugs; moderate and severe cognitive impairment; associated impairment of the type visual and auditory uncorrected; osteotendon and muscle previous surgeries in the last 6 months and access Nintendo Wii at home


Age minimum: 7Y
Age maximum: 14Y
Gender: -

Health Condition(s) or Problem(s) studied

C10.228.140.140.254

Cerebral palsy

Intervention(s)

Device

Two groups randomly assigned. Wii-therapy group and standar-therapy group or control group. Every group have 19 children (ambulatory patients with congenital cerebral palsy Telethon neurological center). Each group will receive therapy in neurological center Telethon.
Wii-therapy group: protocol of exercises that uses Nintendo Wii and balance board. Eighteen sessions given in 6 weeks, 3 times per week, each is 30 minutes long (on monday, wednesday and friday). The exercises were guided by physical therapist. The protocol have three series of exercises. Snowboard, penguin slide and super hula hoop for the first two series of exercises and the yoga game for the third series. In the first series of exercises the children with cerebral palsy are standing with their arms and hands at their sides, in a relaxed manner. The second series of exercises, each game is repeated in a standing position and with their hands on their waist. Between the first and the second series of exercises there will be a 1-2 minute break, moment where the children will sit in a chair till they have recovered. The third series of exercise consists in maintaining their posture as relaxed as possible during the yoga game with eyes open and then repeat it with eyes closed. The children that have great difficulty accomplishing the game snowboard during 3 or 4 continuous sessions, will use a more basic game as run plus or heading football, according to adaptation of the patient.

Standar-therapy group: The exercises were provided by physical therapists of the neurological center (Telethon), which consist of stretching exercises, flexibility, strength and balance. Eighteen sessions given in 6 weeks, 3 times per week (on monday, wednesday and friday), each is 40 minutes long.

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Other

Primary Outcome(s)

Expected results at the end of the Wii therapy significantly was reduced the primary outcome COP area compared to the control group.

Statistical method to analyze the results were: Shapiro-Wilk test and Levene were used to measure the normality and homogeneity of variance, respectively. Mann-Whitney test was used for to determine the differences between the therapies. Friedman's with one-way ANOVA post-hoc pairwise comparisons (Wilcoxon signed-ranks test) were used to determine the effect over time in each type of therapy and types of cerebral palsy. The variables were measured before therapy (week 0), during (week 2 and 4) at the end of therapy (week 6) and follow up (week 8 and 10). P value less than 0.05 was considered statisticallysignificant.
Finally, the results of this research showed that the balance standing improved in children with cerebral palsy Wii therapy group (12.63cm2; 20.38cm2, respectively). The effects of therapy Wii dissipate 2 to 4 weeks after the end of therapy. Standard therapy had no effect on time.

Standing postural balance is a construct defined by the center of pressure (COP) which will be measured in two conditions (eyes open and eyes closed) with the laboratory equipment force platform (AMTI OR67). Increased COP variables is indicative of poor standing balance.
Primary outcome is the COP area, used to calculate the sample size. Six weeks Wii therapy should reduce the area of the COP

Secondary Outcome(s)

Statistical method to analyze the results were: Shapiro-Wilk test and Levene were used to measure the normality and homogeneity of variance, respectively. Mann-Whitney test was used for to determine the differences between the therapies. Friedman's with one-way ANOVA post-hoc pairwise comparisons (Wilcoxon signed-ranks test) were used to determine the effect over time in each type of therapy and types of cerebral palsy. The variables were measured before therapy (week 0), during (week 2 and 4) at the end of therapy (week 6) and follow up (week 8 and 10). P value less than 0.05 was considered statisticallysignificant.

Six weeks of therapy Wii significantly decrease the standard deviation in the AP axis in children with cerebral palsy. Therefore, the Wii therapy improved standing balance on this variable, compared to the control group (12.38cm; 20.63cm, respectively).

Others COP variables secundary outcome are: standard deviation (dispersion of COP displacement from the mean position during a time interval) and velocity (determine how fast were the COP displacements) both are in medial-lateral (M-L) and anterior-posterior (A-P) directions where the increase of these variables will indicate postural balance deficiency.
Six weeks of therapy Wii are expected to decline a secondary variable.

Source(s) of Monetary Support

National Fund for Research and Development in Health

Secondary Sponsor(s)

Telethon Maule, Chile