Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees

Not Applicable

Not yet recruiting

• Conditions: Lower Limb Amputation Knee; Injuries; Biomechanical Lesion
• Interventions: Behavioral: Virtual environment practiced on the Caren; Behavioral: Conventional physiotherapy

• Registration Number: NCT06295380
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Brief Summary

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).

Detailed 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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-28
• Last Update Submitted: 2024-02-28
• Study Start: 2024-03
• Study First Posted: 2024-03-06
• Last Update Posted: 2024-03-06
• Primary Completion: 2024-09
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Virtual environment practiced on the Caren	Virtual environment practiced on the Caren	Caren virtual training phase plus conventional physiotherapy phase
Conventional physiotherapy	Conventional physiotherapy	Conventional physiotherapy phase plus Caren virtual training phase

Primary Outcome Measures

Name	Time	Method
Kinematic data	seven months	From the gait analysis, the investigators will obtain kinematic data, including spatial and temporal parameters measured during standing acquisition and kinematic analysis evaluated from the walking trials recordings.
Kinetic data	seven months	From the gait analysis, the investigators will obtain kinetic data concerning the joint moments and powers, joints moments and powers normalized by the subject's weight (Newton\*meter/kg e Watt/kg) and ground reaction forces reported in percentage to the body weight will be averaged across all cycles for each subject for each evaluating session.
Electromyography	seven months	From the gait analysis, the investigators will obtain electromyographic data on electromyopgraphic signals, regarding muscle contraction, which will be recorded with surface electrodes. The raw signals (millivolts) will be filtered with a band pass filter (20 - 450 Hz) and time-normalized for the duration of the gait cycle (% gait cycle).

Trial Locations

Locations (1)

IRCCS Centro Neurolesi; 🇮🇹 Messina, Sicily, Italy