Clinical trial NCT03353623: Immersive Virtual Environments and Wearable Haptic Devices in Rehabilitation of Children With Neuromotor Impairments
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Dyspraxia
Keywords: Immersive Virtual Environments
Wearable Haptic Devices
Neuromotor Impairments
Rehabilitation
Serious Game
Randomized Controlled Trial
Lead sponsor: Scuola Superiore Sant'Anna di Pisa
Sponsor class: OTHER
Collaborators: name: Unit of Developmental Neurorehabilitation, Pisa University Hospital
First posted: 2017-11-27
Enrollment: 8
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Time Scores on Nine Hole Peg Test (9-HPT) for both Dominant and Non-Dominant Hands at 4, 8, 16 and 24 weeks
timeFrame: Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)
measure: Change From Baseline in Kinematic Metrics on Linear Path Tracking (LPT) and Reach-to-Grasp (RtG) Tasks for Dominant Hand at 4, 8, 16 and 24 weeks
timeFrame: Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)
Secondary outcomes:
measure: Number of Participants with Treatment-Related Adverse Events according to the CTCAE v.4.0
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital
state: PI
Study officials:
affiliation: PERCRO Laboratory, Scuola Superiore Sant'Anna, via L. Alamanno 13b, 56010 Ghezzano, Pisa, Italy
name: Ilaria Bortone, PhD
role: STUDY_CHAIR
References:
citation: Leonardis D, Solazzi M, Bortone I, Frisoli A. A 3-RSR Haptic Wearable Device for Rendering Fingertip Contact Forces. IEEE Trans Haptics. 2017 Jul-Sep;10(3):305-316. doi: 10.1109/TOH.2016.2640291. Epub 2016 Dec 15.
citation: Bortone I, Leonardis D, Solazzi M, Procopio C, Crecchi A, Bonfiglio L, Frisoli A. Integration of serious games and wearable haptic interfaces for Neuro Rehabilitation of children with movement disorders: A feasibility study. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:1094-1099. doi: 10.1109/ICORR.2017.8009395.
citation: Leonardis, D., Solazzi, M., Bortone, I., & Frisoli, A. (2015, June). A wearable fingertip haptic device with 3 dof asymmetric 3-rsr kinematics. In World Haptics Conference (WHC), 2015 IEEE (pp. 388-393). IEEE.
citation: Bortone, I., Leonardis, D., Solazzi, M., Procopio, C., Crecchi, A., Briscese, L., ... & Frisoli, A. (2017). Serious Game and Wearable Haptic Devices for Neuro Motor Rehabilitation of Children with Cerebral Palsy. In Converging Clinical and Engineering Research on Neurorehabilitation II (pp. 443-447). Springer International Publishing.
citation: Bortone I, Barsotti M, Leonardis D, Crecchi A, Tozzini A, Bonfiglio L, Frisoli A. Immersive Virtual Environments and Wearable Haptic Devices in rehabilitation of children with neuromotor impairments: a single-blind randomized controlled crossover pilot study. J Neuroeng Rehabil. 2020 Oct 28;17(1):144. doi: 10.1186/s12984-020-00771-6.