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Study of Motor Recovery and Biomechanical Adaptation Mechanisms in Amputee Patients Using an Immersive Virtual Reality System (CAREN)
Interventional, non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment, aiming at the enhancement of use-dependent brain plasticity. These changes will be compared between the two groups examined, respectively experimental (Caren virtual training phase plus conventional physiotherapy phase) and control (conventional physiotherapy phase plus Caren virtual training phase).
Primary objectives: Evaluation of biomechanical and spatio-temporal asymmetries in gait in subjects with lower limb amputation by motion capture systems; improvement of postural stability and gait cycle in patients with lower limb amputation by "task-oriented" rehabilitation training and multisensory feedback generated by an immersive virtual reality environment, aiming at the enhancement of use-dependent brain plasticity; improving body weight distribution on both lower limbs, during static and dynamic activities, through more effective control of the body's centre of gravity. Secondary objectives include improving mood, psycho-social wellbeing and quality of life in lower limb amputees.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
IRCCS Centro Neurolesi
Messina, Sicily, Italy
Start Date
March 1, 2024
Primary Completion Date
September 1, 2024
Completion Date
March 1, 2025
Last Updated
March 6, 2024
24
ESTIMATED participants
Virtual environment practiced on the Caren
BEHAVIORAL
Conventional physiotherapy
BEHAVIORAL
Lead Sponsor
IRCCS Centro Neurolesi Bonino Pulejo
NCT05563103
NCT06521723
NCT06085586
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