Immersive Virtual Environments and Wearable Haptic Devices in Rehabilitation of Children With Neuromotor Impairments (SERIOUSGAME)

Scuola Superiore Sant'Anna di Pisa

Status: Completed

Conditions: Cerebral Palsy; Dyspraxia

Treatments: Other: Conventional Therapy; Device: Serious Game

Study type: Interventional

Funder types: Other

Identifiers

NCT03353623

[SG]-CIV-IT-17-04-019324

Details and patient eligibility

About

The investigators proposed a controlled, single-blind, unicentric, crossover, randomized, clinical trial to test the effects of immersive virtual environments and wearable haptic devices in the rehabilitation of children with neuromotor impairments. In addition, the proposed approach was compared with respect to conventional therapy.

A sample of 8 participants was randomly divided into 2 groups and they attended one of the two therapeutic approach for 4 weeks before crossing over and inverting the therapy. Between the two interventions, there was a wash out period of 4 weeks.

The investigators assessed motor abilities of the children with validated clinical scales and motion analysis before/after each phase of the study (T0: baseline, T1: after 4 weeks, T2: after 8 weeks, T3: after 16 weeks, and T4: up to 24 weeks).

Full description

A Randomized Controlled Crossover Trial was designed to examine the usability and effectiveness of serious games and wearable haptic interfaces in rehabilitation of children with neuromotor impairments. The ethics board of Tuscany Region and the Italian Ministry of Health approved this study. All parents freely accepted the participation of their children in the study and provided written informed consent.

The investigators recruited eight patients, both male and female, 3 children with Cerebral Palsy (CP) and 5 children with Developmental Dyspraxia (DD) (mean age = 10,30±2,88 years), who were currently receiving conventional therapy at Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital, and eight Typically Developing children (TD, mean age = 9,60±2,61 years). All the patients were right-handed and they did not have previous experiences with Virtual Reality (VR) and/or haptic devices, while TD children have previously experienced with commercial video games.

Following recruitment, screening and consent and baseline assessments, participants are randomized to an order of VR-assisted rehabilitation (ISG-Group, Immediate Serious Games, or DSG-Group, Delayed Serious Games). Participants were setup in their first condition and were assessed at the end of the 4 week intervention. Participants were then set up in their second period for 4 weeks, again with assessment occurring at the end of the intervention. Among the two interventions, a wash out period of 4 weeks was inserted and children followed only cognitive therapy with no physical sessions.

The study protocol consisted of a total of 16 sessions with both VR-assisted and conventional rehabilitation (2 sessions per week for 4 weeks for 2 periods) and involved a familiarization and a training phase. The investigators adopted different established clinical scales for children with CP and DD in order to assess patients' abilities during the assessments. The investigators also selected metrics obtained from end-point (hand) kinematic data, including movement speed and accuracy, in order to have quantitative measurements of patients' motor abilities.

Enrollment: 8 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• a history of neuromotor disorders (CP or DD)
• a maximum age of 18 years
• a minimum ability to actively grasp an object
• the ability to understand simple instructions
• low to severe impairments of the upper limbs

Exclusion criteria

• epileptic patients
• severe deficit in sensory perception of upper limb
• severe visual impairments
• severe cognitive diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 2 patient groups

ISG-Group (Immediate Serious Game)

Experimental group

Description:

Children in the ISG-Group first participated in the VR-assisted rehabilitation, which consisted in 8 sessions with immersive virtual environment and wearable haptic devices, and were then crossed over and followed during an intended duration of 6 hours of conventional therapy.

Treatment:

Device: Serious Game

Other: Conventional Therapy

DSG-Group (Delayed Serious Game)

Experimental group

Description:

Children from DSG-Group were followed during an intended duration of 6 hours of conventional therapy before receiving VR-assisted rehabilitation with immersive virtual environment and wearable haptic devices.

Treatment:

Device: Serious Game

Other: Conventional Therapy