Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees

IRCCS Centro Neurolesi "Bonino-Pulejo"

Status: Not yet enrolling

Conditions: Lower Limb Amputation Knee; Injuries; Biomechanical Lesion

Treatments: Behavioral: Virtual environment practiced on the Caren; Behavioral: Conventional physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06295380

CarenAmp

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• unilateral lower limb amputation
• ability to walk independently
• age between 18 and 75 years
• absence of severe comorbidities that may interfere with treatment

Exclusion criteria

• presence of severe neurological and psychiatric disorders
• walking with aids

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Virtual environment practiced on the Caren

Experimental group

Description:

Caren virtual training phase plus conventional physiotherapy phase

Treatment:

Behavioral: Virtual environment practiced on the Caren

Conventional physiotherapy

Active Comparator group

Description:

Conventional physiotherapy phase plus Caren virtual training phase

Treatment:

Behavioral: Conventional physiotherapy