Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Injuries; Lower Limb Amputation Knee; Biomechanical Lesion
• Intervention / Treatment: Behavioral: Virtual environment practiced on the Caren; Behavioral: Conventional physiotherapy

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mirjam Bonanno, PT; Phone Number: +3909060128179; Email: mirjam.bonanno@irccsme.it
• Study Contact Backup: Name: Rocco Salvatore Calabrò, MD; Phone Number: +3909060128179; Email: roccos.calabro@irccsme.it

Study Locations

• Italy
  • Sicily
    • Messina, Sicily, Italy, 98124
      • IRCCS Centro Neurolesi
      • Contact: Rocco Salvatore Calabrò, MD; Phone Number: +39 09060128179; Email: roccos.calabro@irccsme.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual environment practiced on the Caren; Caren virtual training phase plus conventional physiotherapy phase	Behavioral: 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.
Active Comparator: Conventional physiotherapy; Conventional physiotherapy phase plus Caren virtual training phase	Behavioral: Conventional physiotherapy; Conventional physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematic data	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.	seven months
Kinetic data	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.	seven months
Electromyography	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).	seven months

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Investigators: Principal Investigator: Giuseppe Paladina, PT, IRCCS Centro Neurolesi "Bonino-Pulejo"

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; virtual reality
• Other Study ID Numbers: CarenAmp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After the data collection we will report anonymised data on public repository

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No