Study of Navigation Skills in Cerebral Palsy for Assessment and Rehabilitation in Immersive Virtual Reality

NCT ID: NCT04270305

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-09
• Study Completion Date: 2021-07-31

Brief Summary

Spatial navigation refers to the ability to maintain a sense of direction/location while moving around the environment so to find one's way. It includes abilities such as orienting in complex environments,perceiving distance and planning routes to distant locations as well as mentally representing the reciprocal relations of landmarks in space (Lawton, 2010; Wolbers & Hegarty 2010. Spatial navigation involves the precision in encoding multisensorial (visual, vestibular, proprioceptive)experiences, as well as to form mental representations to be used to guide behavior (Bianchini et al.,2014).

Cerebral Palsy (CP) is a neurodevelopmental disorder characterized by movement and posture disorders causing activity limitation. Impairment in many other functions is common in CP including visual spatial competences and spatial organization. In this study the investigators meant to explore the navigation and learning strategies in children with CP.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

orientation

Orientation training with GRAIL

Group Type: EXPERIMENTAL

Orientation

Intervention Type: OTHER

In the first group CP patients undergo a four week training with once daily sessions lasting 30 minutes. The treatment includes exercises to improve navigation competences and orientation. During walk in VR environment with labyrinths of increasing complexity. Exercises include abilities such as orienting in complex environments, perceiving distance and planning routes to distant locations. The presence of landmarks has been included in some exercises to facilitate allocentric orientation strategies.

walking

Walking training with GRAIL

Group Type: ACTIVE_COMPARATOR

walking

Intervention Type: OTHER

In the second group CP patients undergo a four week training with once daily sessions lasting 30 minutes. The treatment includes exercises to improve walking and balance abilities. Using engaging VR environments (e.g. transfer your load from the left to the right side to avoid obstacles while skiing; shoot balls at targets inside an area; walk in a forest as fast as possible; hit as many elves as possible by squatting, and so on). No exercises for orientation are included in this group.

Interventions

Orientation

In the first group CP patients undergo a four week training with once daily sessions lasting 30 minutes. The treatment includes exercises to improve navigation competences and orientation. During walk in VR environment with labyrinths of increasing complexity. Exercises include abilities such as orienting in complex environments, perceiving distance and planning routes to distant locations. The presence of landmarks has been included in some exercises to facilitate allocentric orientation strategies.

Intervention Type: OTHER

walking

In the second group CP patients undergo a four week training with once daily sessions lasting 30 minutes. The treatment includes exercises to improve walking and balance abilities. Using engaging VR environments (e.g. transfer your load from the left to the right side to avoid obstacles while skiing; shoot balls at targets inside an area; walk in a forest as fast as possible; hit as many elves as possible by squatting, and so on). No exercises for orientation are included in this group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• diagnosis of bilateral CP;
• age between 8 and 14 years old;
• severity of motor impairment classified in levels I, II and III, according to the Gross Motor Function Classification System (GMFCS) (Palisano et al., 1997)
• or according to the Manual Ability Classification System (MACS) (Eliasson et al., 2006);
• ability to follow instructions.

Exclusion Criteria

• severe muscle spasticity and/or contracture,
• a diagnosis of severe learning disability,
• behavioral problems,
• visual or hearing difficulties that would affect the feasibility of proposed activities and/or compliance

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Medea

Bosisio Parini, LC, Italy

Countries

Italy

Other Identifiers

308

Identifier Type: -

Identifier Source: org_study_id