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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)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06295380
Enrollment
24
Registered
2024-03-06
Start date
2024-03-31
Completion date
2025-03-31
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomechanical Lesion, Injuries, Lower Limb Amputation Knee

Keywords

rehabilitation, virtual reality

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.

Interventions

BEHAVIORALVirtual 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.

BEHAVIORALConventional physiotherapy

Conventional physiotherapy

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Kinematic dataseven monthsFrom 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 dataseven monthsFrom 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.
Electromyographyseven monthsFrom 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).

Countries

Italy

Contacts

Primary ContactMirjam Bonanno, PT
mirjam.bonanno@irccsme.it+3909060128179
Backup ContactRocco Salvatore Calabrò, MD
roccos.calabro@irccsme.it+3909060128179

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026