Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2025-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Lower Limb Amputation Knee Injuries Biomechanical Lesion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual environment practiced on the Caren

Caren virtual training phase plus conventional physiotherapy phase

Group Type EXPERIMENTAL

Virtual environment practiced on the Caren

Intervention Type BEHAVIORAL

The virtual environment practised on the Caren will make the scenario totally immersive and allow the subject to perform the motor task by recruiting muscles according to a motor coordination scheme different from the traditional one.

Conventional physiotherapy

Conventional physiotherapy phase plus Caren virtual training phase

Group Type ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type BEHAVIORAL

Conventional physiotherapy

Interventions

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Virtual environment practiced on the Caren

The virtual environment practised on the Caren will make the scenario totally immersive and allow the subject to perform the motor task by recruiting muscles according to a motor coordination scheme different from the traditional one.

Intervention Type BEHAVIORAL

Conventional physiotherapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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