Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees

NCT06295380 | Not Yet Recruiting

• 1 other identifier: CarenAmp
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Lower Limb Amputation Knee; Injuries; Biomechanical Lesion

Keywords

rehabilitation; virtual reality

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Virtual environment practiced on the Caren

EXPERIMENTAL

Caren virtual training phase plus conventional physiotherapy phase

Behavioral: Virtual environment practiced on the Caren

Conventional physiotherapy

ACTIVE COMPARATOR

Conventional physiotherapy phase plus Caren virtual training phase

Behavioral: Conventional physiotherapy

Interventions

Virtual environment practiced on the Caren 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.

Virtual environment practiced on the Caren

Conventional physiotherapy BEHAVIORAL

Conventional physiotherapy

Conventional physiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi

Messina, Sicily, 98124, Italy

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Giuseppe Paladina, PT

  IRCCS Centro Neurolesi Bonino Pulejo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirjam Bonanno, PT

CONTACT

+3909060128179; mirjam.bonanno@irccsme.it

Rocco Salvatore Calabrò, MD

CONTACT

+3909060128179; roccos.calabro@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 6, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)