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

NCT03353623 | Completed DMC

• 1 other identifier: [SG]-CIV-IT-17-04-019324
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Cerebral Palsy; Dyspraxia

Keywords

Immersive Virtual Environments; Wearable Haptic Devices; Neuromotor Impairments; Rehabilitation; Serious Game; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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

  Nine Hole Peg Test (9-HPT) is a brief, standardized, quantitative test of upper extremity function. Both the dominant and non-dominant hands are tested twice. The child is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes. On a start command when a stopwatch is started, the child picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded.

  Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)

• 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

  The evaluation task consisted of two reach-to-grasp tasks requiring forearm pronation or supination and three linear path tracking (forward and sideways). For the RtG task, the child was asked to flip a card protruding from an horizontal support. For the LPT, the child was seated in front of a desk with the hand positioned, at rest, close to the body on the sagittal plane. Then a target was put on the desk (always at the same distance from the starting position) and the child was asked to reach the target by moving the hand along a straight path. All tasks were performed with the preferred arm at self selected speed. The investigators then extracted kinematic metrics (movement speed, accuracy and smoothness) from end-point (hand) kinematic data.

  Baseline (T0), 4 weeks (T1), 8 weeks (T2), 16 weeks (T3), 24 weeks (T4)

Secondary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events according to the CTCAE v.4.0

  Up to 16 weeks

Study Arms (2)

ISG-Group (Immediate Serious Game)

EXPERIMENTAL

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.

Device: Serious Game; Other: Conventional Therapy

DSG-Group (Delayed Serious Game)

EXPERIMENTAL

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.

Device: Serious Game; Other: Conventional Therapy

Interventions

Serious Game DEVICE

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.

DSG-Group (Delayed Serious Game); ISG-Group (Immediate Serious Game)

Conventional Therapy OTHER

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.

DSG-Group (Delayed Serious Game); ISG-Group (Immediate Serious Game)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Scuola Superiore Sant'Anna di Pisa: lead
• Unit of Developmental Neurorehabilitation, Pisa University Hospital: collaborator

Study Sites (1)

Unit of Developmental Neurorehabilitation, Maternal and Child Department, Pisa University Hospital

Pisa, PI, 56100, Italy

Location

Related Publications (5)

• 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.

  PMID: 28113306 RESULT

• 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.

  PMID: 28813967 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 33115487 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Apraxias

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ilaria Bortone, PhD

  PERCRO Laboratory, Scuola Superiore Sant'Anna, via L. Alamanno 13b, 56010 Ghezzano, Pisa, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study was masked only for the medical doctor who performed the motor assessments with clinical scales: she did not follow the rehabilitation sessions.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Robotics and Mechanical Engineering

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 27, 2017
• Study Start: February 13, 2017
• Primary Completion: June 6, 2017
• Study Completion: October 9, 2017
• Last Updated: November 27, 2017

Record last verified: 2017-11

Locations

IT (1)