Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees

Injuries Clinical Trial

Official title:

Study of Motor Recovery and Biomechanical Adaptation Mechanisms in Amputee Patients Using an Immersive Virtual Reality System (CAREN)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295380
• Other study ID #: CarenAmp
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: Mirjam Bonanno, PT
• Phone: +3909060128179
• Email: mirjam.bonanno[@]irccsme.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Injuries
• Lower Limb Amputation Knee

Intervention

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.
• Conventional physiotherapy
Conventional physiotherapy

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi	Messina	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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