NCT03353623

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

A Randomized Controlled Single-Blind Crossover Trial on the Effects of Serious Games and Wearable Haptic Devices in the Rehabilitation of Children With Neuromotor Impairments

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Scuola Superiore Sant'Anna di Pisa · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed 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.

Conditions

• Cerebral Palsy
• Dyspraxia

Interventions

Type	Name	Description
DEVICE	Serious Game	Serious Game (SG) refers to the use of immersive virtual environments and wearable haptic devices during the treatment. Two SG were specifically developed to allow a playful training of different, targeted Upper Limb (UL) movement based on typical rehabilitation exercises (reach-to-grasp, linear path tracking, hand orientation). The child interacts directly with a virtual environment through haptic feedback provided to his/her fingertips. In particular, "moneybox game" focused on pincer grasp and reaching tasks with pronation/supination od the hand while "marble labyrinth game" focused on pointing and tracking movements requiring both eye-hand and upper limb inter-joint coordination.
OTHER	Conventional Therapy	Conventional therapy (CONV) refers to the neurocognitive rehabilitation approach, with the purpose of improving pointing, tracking, reaching and grasping, and pronation/supination of the forearm. The therapeutic sessions were performed with the exception of the visual channel to ensure that the child focused his/her attention on tactile/kinesthetic information to complete the task. In particular, five different tasks have been proposed during the sessions: 1) recognize trajectories; 2) arm proprioception; 3) object manipulation; 4) recognize surfaces; 5) forearm orientation.

Timeline

• Start date: 2017-02-13
• Primary completion: 2017-06-06
• Completion: 2017-10-09
• First posted: 2017-11-27
• Last updated: 2017-11-27

Locations

1 site across 1 country: Italy