NCT04560764

Physiotherapy and Action-Observation Therapy: An Integrated Approach for Upper Limb Impairment in Subacute Stroke

Virtual Reality and Action-Observation Therapy: An Integrated Approach Supported by Novel Technologies for Upper Limb Impairment in Subacute Stroke

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fondazione Don Carlo Gnocchi Onlus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Motor impairment is one of the most common result of a stroke, which causes disability and difficulties in activities of daily living. This motor impairment can concern the upper limb or the lower limb, or both. Several studies investigates the efficacy of different treatment approaches on upper limb and hand function. None of them combined exercise in a virtual context with Action Observation Therapy, consisting in watching an action before doing it. This study evaluates the addition of Action Observation Therapy (AOT) to Virtual Reality (VR) in the rehabilitation of upper limb impairment in subacute stroke patients. Half of participants will see a video demonstrating the exercise to be performed before its actual execution, while the other half will see a video of a natural landscape followed by the same exercises the other group performs. All the patients will receive additional usual treatment.

Detailed description

In this study, the intervention will be conducted using a system composed by multiple devices, which are: * HTC Vive (HTC, headset e Steam station): three-dimensional viewer used for the implementation of the immersive virtual environment, allows both the visualization of the videos and of the exercises to be performed; * Leap Motion Controller (infrared camera): contactless device for tracking the movement of the patient's fingers and hand; * Zed Mini (RGB binocular camera and depth camera): Stereo Labs' Zed Mini stereoscopic camera is mounted on the HTC Vive viewer to allow virtual elements to be overlapped within the environment; * Cometa Wavetrack (transmitter/receiver and Inertial Measurement Units): system for upper limb movement tracking through the use of four wireless inertial sensors applied to the chest, to the arm and to the forearm of the participant through elastic bands and to the hand of the participant through skin-compatible double-sided adhesive patches. All the devices have been tested to ensure safety of the participants and are provided with the appropriate documentation of declaration of conformity according to the European reference regulations. A careful risk analysis was carried out to ensure the safety of the participants. All the devices will be working simultaneously during each session of treatment. For the experimental group, the instrumentation will be used to see the video of the exercises that the participants will be later asked to perform and to actually perform them; in the control group, it will be used to see a video of a natural landscape with a 180° perspective and to perform the same exercises than the experimental group. The devices will be used both for the execution of the exercises both to collect information listed in the outcomes section as secondary outcomes: in particular, these information will be provided by the Leap Motion and by the Cometa Wavetrack devices.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Virtual Reality	Participants in both groups will attend 10 sessions of approximately 30 minutes each three times a week. Each session contemplates the execution of a single repetition of two minutes of each of the four exercises. There are four exercises: 1. Reaching: the participant is requested to reach a target in front of him with the paretic hand; the target will appear in a different place every time; 2. Reaching and grasping: the participant is requested to grab a wooden cube with the paretic hand and place it into a bowl positioned in front of him; the cube will appear in a different place every time; 3. Goalkeeper: the participant is requested to block a ball coming towards him with the paretic hand; the ball will appear in a different place every time; 4. Occupational task: the participant is requested to grab four cans, one at time, with the paretic hand and place them on four targets placed on a hemispherical arch. Each exercise provides six levels of increasing difficulty.
DEVICE	Action Observation Therapy	Before the execution of the exercises described in the intervention "Virtual Reality", the participants in the experimental group will see a video demonstrating the same exercise (according to the level of difficulty selected) he will be later asked to perform for two minutes.
DEVICE	Landscape video	Before the execution of the exercises described in the intervention "Virtual Reality", the participants in the sham comparator group will see a video of a natural landscape for two minutes.
OTHER	Standard treatment	Participants in both groups will receive the standard treatment, one hour a day for three days a week.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-06-01
• Completion: 2023-12-30
• First posted: 2020-09-23
• Last updated: 2024-08-12

Locations

1 site across 1 country: Italy