An interventional study of Virtual environment practiced on the Caren and Conventional physiotherapy in Lower Limb Amputation Knee, Injuries and Biomechanical Lesion, sponsored by IRCCS Centro Neurolesi Bonino Pulejo. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by IRCCS Centro Neurolesi Bonino Pulejo · Not applicable, Interventional, and Treatment
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).
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.
IRCCS Centro Neurolesi Bonino Pulejo is the lead sponsor of 67 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Caren virtual training phase plus conventional physiotherapy phase
Behavioral: Virtual environment practiced on the Caren
Conventional physiotherapy phase plus Caren virtual training phase
Behavioral: Conventional physiotherapy
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
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.
Time frame: 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.
Time frame: 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).
Time frame: seven months
Plan to share: No — After the data collection we will report anonymised data on public repository
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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IRCCS Centro Neurolesi Bonino Pulejo