Lower Limb Amputation KneeNCT06295380
Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees
A study testing Virtual environment practiced on the Caren and Conventional physiotherapy in people with Lower Limb Amputation Knee and Injuries, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lower Limb Amputation Knee, Injuries, Biomechanical Lesion
- What is being tested?
- Virtual environment practiced on the Caren and Conventional physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral lower limb amputation
- ability to walk independently
- age between 18 and 75 years
- absence of severe comorbidities that may interfere with treatment
Who cannot join
- presence of severe neurological and psychiatric disorders
- walking with aids
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Centro Neurolesi
Messina, Sicily, 98124
Rocco Salvatore Calabrò, MD, 09060128179 ext. +39, roccos.calabro@irccsme.it
About this study
Official title: 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).
Read the 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.
- Conditions
- Lower Limb Amputation Knee, Injuries, Biomechanical Lesion
- Being tested
- Virtual environment practiced on the Caren, Conventional physiotherapy
- Keywords
- rehabilitation, virtual reality
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual environment practiced on the CarenBehavioural
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 physiotherapyBehavioural
Conventional physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Virtual environment practiced on the Caren | Experimental | Caren virtual training phase plus conventional physiotherapy phase Receives: Behavioral: Virtual environment practiced on the Caren |
| Conventional physiotherapy | Active comparator | Conventional physiotherapy phase plus Caren virtual training phase Receives: Behavioral: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirjam Bonanno, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Giuseppe Paladina, PT, Principal investigator, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295380
- Sponsor's protocol ID
- CarenAmp
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the data collection we will report anonymised data on public repository
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Motor Recovery and Biomechanical Adaptation Mechanisms in Amputee Patients Using an Immersive Virtual Reality System (CAREN)
- ClinicalTrials.gov ID
- NCT06295380
- Acronym / sponsor ID
- CarenAmp
- Conditions
- Lower Limb Amputation Knee, Injuries, Biomechanical Lesion
- Keywords
- rehabilitation, virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual environment practiced on the Caren | Experimental | Behavioral: Virtual environment practiced on the CarenCaren virtual training phase plus conventional physiotherapy phase |
| Conventional physiotherapy | Active comparator | Behavioral: Conventional physiotherapyConventional physiotherapy phase plus Caren virtual training phase |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- unilateral lower limb amputation
- ability to walk independently
- age between 18 and 75 years
- absence of severe comorbidities that may interfere with treatment
Key exclusion criteria (2 listed)
- presence of severe neurological and psychiatric disorders
- walking with aids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual environment practiced on the CarenThe 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. | Behavioural | Virtual environment practiced on the Caren |
| Conventional physiotherapyConventional physiotherapy | Behavioural | Conventional physiotherapy |
Primary outcome
Kinematic data
Time frame: seven months
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.
Kinetic data
Time frame: seven months
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.
Electromyography
Time frame: seven months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No. After the data collection we will report anonymised data on public repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Paladina, PT principal investigator
IRCCS Centro Neurolesi Bonino Pulejo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual environment practiced on the Caren and Conventional physiotherapy in people with Lower Limb Amputation Knee and Injuries, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mirjam Bonanno, PT (+3909060128179, mirjam.bonanno@irccsme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic data (time frame: seven months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.