Immersive Virtual Environments and Wearable Haptic Devices in Rehabilitation of Children With Neuromotor Impairments
Condition: Cerebral Palsy; Dyspraxia
MeSH terms: Cerebral Palsy
Study type: Interventional

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.
    

Intervention name(s): Serious Game; Conventional Therapy
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The investigators adopted a 2x2 crossover design (2-sequence, 2-period, 2-treatment crossover design, with sequences AB and BA): each participant received both conventional and VR-aided therapy for a period of 4 weeks per treatment (2 sessions per week of 45 minutes) assigned in a different order. A wash out period of 4 weeks was included before the second period of intervention started.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Immersive Virtual Environments; Wearable Haptic Devices; Neuromotor Impairments; Rehabilitation; Serious Game; Randomized Controlled Trial