Amputees / RehabilitationEQUIL-ARCNCT06424249
Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
A study testing Virtual Reality and Standard rehabilitation in people with Amputees / Rehabilitation and Virtual Reality, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
Amputation causes somatic and psychological damage. Prognostic factors for postoperative gait recovery include the need for proprioceptive re-education for dynamic balance. Improved gait patterns and use of the prosthesis contribute to an overall improvement in the amputee's autonomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amputees / Rehabilitation, Virtual Reality, Postural Balance
- What is being tested?
- Virtual Reality and Standard rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral transtibial amputees in hospitalized in the rehabilitation of the musculoskeletal system service
- All etiologies: vascular, traumatic and septic.
- Adapted vascular equipment validated by physician.
- Able to walk for 5 minutes on a treadmill without technical assistance.
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- The subject is participating in an interventional study or one involving a drug or medical device, or is in a period of exclusion determined by a previous study
- Patient already included in the present study.
- The subject refuses to or is unable to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patients with uncorrected or untreated visual disorders.
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- Patients with major cognitive disorders (MOCA>23).
- Patients with vestibular disorders.
- Patient with uncontrolled epilepsy.
- Patient with an unhealed amputation stump.
- Patients weighing > 135kg or < 20kg.
- Patients with a functional ambulation category of 1 (i.e. patients requiring the firm, continuous assistance of another person to carry their weight and maintain their balance) or less.
- Patients with medication affecting exercise tolerance,
- Patients with sensory impairments
- Patients with significantly reduced bone density
- Patients for whom it is impossible to correctly adjust the harness to the corresponding body part due to:
- Body shape
- Colostomy bags
- Skin lesions that cannot be adequately protected.
- Any other reason that prevents proper, pain-free adjustment of the sling.
- Pregnant, parturient or breast-feeding patients.
- Appearance of a stump wound during the study requiring discharge.
- Patient with more than 50% absenteeism from rehabilitation sessions.
- Patient requiring a new prosthesis insert.
- Patient with a serious adverse event affecting dynamic balance rehabilitation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU de Nîmes, Hôpital du Grau du Roi
Le Grau-du-Roi, 30240
Eric PANTERA, MD
- Not yet recruiting
CHU de Nimes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Eric Pantera
About this study
Amputation causes somatic and psychological damage. Prognostic factors for postoperative gait recovery include the need for proprioceptive re-education for dynamic balance. Improved gait patterns and use of the prosthesis contribute to an overall improvement in the amputee's autonomy. Virtual reality coupled with movement analysis allows personalization of treatment with objective assessment of progress.
The study authors hypothesize that a virtual reality protocol for the dynamic balance of a unilateral transtibial amputee in initial rehabilitation will improve the dynamic balance assessment criteria compared with a conventional rehabilitation protocol.
- Conditions
- Amputees / Rehabilitation, Virtual Reality, Postural Balance
- Being tested
- Virtual Reality, Standard rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
A progressive rehabilitation protocol (different levels according to success scores) consisting of several exercises using virtual and augmented reality with mechanical perturbations (pitching of the treadmill), interaction with the virtual environment, interaction with the virtual environment and augmented reality (projection of obstacles on the treadmill), and modification of the gait pattern with visual and/or audio biofeedback
Standard rehabilitationOther
A treadmill walking protocol with virtual reality to immerse the patient in a 3 x 5-minute walking session, without visual, mechanical or auditory disturbances, and without prompting the patient to modify their walking pattern.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality group | Experimental | Not described Receives: Other: Virtual Reality |
| Control group | Active comparator | Not described Receives: Other: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mediolateral instability during mediolateral external perturbation between groups
The number of gait cycles required to regain center of mass displacement (number of cycles * cycle time), measured with the GRAIL rehabilitation and movement analysis platform
Measured: Before rehabilitation (Day 1)
Mediolateral instability during mediolateral external perturbation between groups
The number of gait cycles required to regain center of mass displacement (number of cycles * cycle time), measured with the GRAIL rehabilitation and movement analysis platform
Measured: End of rehabilitation sessions (Day 45)
Secondary outcomes (14)
Step length variability between groups
Meters, measured with the GRAIL rehabilitation and movement analysis platform
Measured: Before rehabilitation (Day 1)
Step length variability between groups
Meters, measured with the GRAIL rehabilitation and movement analysis platform
Measured: End of rehabilitation sessions (Day 45)
Step width variability between groups
Meters, measured with the GRAIL rehabilitation and movement analysis platform
Measured: Before rehabilitation (Day 1)
Step width variability between groups
Meters, measured with the GRAIL rehabilitation and movement analysis platform
Measured: End of rehabilitation sessions (Day 45)
Cadence variability between groups
Steps/minute, measured with the GRAIL rehabilitation and movement analysis platform
Measured: Before rehabilitation (Day 1)
Cadence variability between groups
Steps/minute, measured with the GRAIL rehabilitation and movement analysis platform
Measured: End of rehabilitation sessions (Day 45)
Center of mass variability between groups
Meters, measured with the GRAIL rehabilitation and movement analysis platform
Measured: Before rehabilitation (Day 1)
Center of mass variability between groups
Meters, measured with the GRAIL rehabilitation and movement analysis platform
Measured: End of rehabilitation sessions (Day 45)
Mobility and balance between groups
Time Up and Go test, seconds
Measured: Before rehabilitation (Day 1)
Mobility and balance between groups
Time Up and Go test, seconds
Measured: End of rehabilitation sessions (Day 45)
Aerobic endurance and functional capacity between groups
2-minute walk test, meters
Measured: Before rehabilitation (Day 1)
Aerobic endurance and functional capacity between groups
2-minute walk test, meters
Measured: End of rehabilitation sessions (Day 45)
Fall risk between groups
Berg scale, score between 0 and 56 (no fall risk)
Measured: Before rehabilitation (Day 1)
Fall risk between groups
Berg scale, score between 0 and 56 (no fall risk)
Measured: End of rehabilitation sessions (Day 45)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start14 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputees / RehabilitationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Pantera, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424249
- Sponsor's protocol ID
- Local/2023/EP-02
- Acronym
- EQUIL-ARC
- Status last verified
- Jun 2026
- First submitted
- 16 May 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
- ClinicalTrials.gov ID
- NCT06424249
- Acronym / sponsor ID
- EQUIL-ARC / Local/2023/EP-02
- Conditions
- Amputees / Rehabilitation, Virtual Reality, Postural Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 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.
Amputation causes somatic and psychological damage. Prognostic factors for postoperative gait recovery include the need for proprioceptive re-education for dynamic balance. Improved gait patterns and use of the prosthesis contribute to an overall improvement in the amputee's autonomy. Virtual reality coupled with movement analysis allows personalization of treatment with objective assessment of progress.
The study authors hypothesize that a virtual reality protocol for the dynamic balance of a unilateral transtibial amputee in initial rehabilitation will improve the dynamic balance assessment criteria compared with a conventional rehabilitation protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality group | Experimental | Other: Virtual Reality |
| Control group | Active comparator | Other: Standard rehabilitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral transtibial amputees in hospitalized in the rehabilitation of the musculoskeletal system service
- All etiologies: vascular, traumatic and septic.
- Adapted vascular equipment validated by physician.
- Able to walk for 5 minutes on a treadmill without technical assistance.
- The patient must have given their free and informed consent and signed the consent form
Key exclusion criteria (25 listed)
- The subject is participating in an interventional study or one involving a drug or medical device, or is in a period of exclusion determined by a previous study
- Patient already included in the present study.
- The subject refuses to or is unable to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
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 RealityA progressive rehabilitation protocol (different levels according to success scores) consisting of several exercises using virtual and augmented reality with mechanical perturbations (pitching of the treadmill), interaction with the virtual environment, interaction with the virtual environment and augmented reality (projection of obstacles on the treadmill), and modification of the gait pattern with visual and/or audio biofeedback | Other | Virtual Reality group |
| Standard rehabilitationA treadmill walking protocol with virtual reality to immerse the patient in a 3 x 5-minute walking session, without visual, mechanical or auditory disturbances, and without prompting the patient to modify their walking pattern. | Other | Control group |
Primary outcome
Mediolateral instability during mediolateral external perturbation between groups
Time frame: Before rehabilitation (Day 1)
The number of gait cycles required to regain center of mass displacement (number of cycles * cycle time), measured with the GRAIL rehabilitation and movement analysis platform
Mediolateral instability during mediolateral external perturbation between groups
Time frame: End of rehabilitation sessions (Day 45)
The number of gait cycles required to regain center of mass displacement (number of cycles * cycle time), measured with the GRAIL rehabilitation and movement analysis platform
14 secondary outcomes
Step length variability between groups
Time frame: Before rehabilitation (Day 1)
Step length variability between groups
Time frame: End of rehabilitation sessions (Day 45)
Step width variability between groups
Time frame: Before rehabilitation (Day 1)
Step width variability between groups
Time frame: End of rehabilitation sessions (Day 45)
Cadence variability between groups
Time frame: Before rehabilitation (Day 1)
Cadence variability between groups
Time frame: End of rehabilitation sessions (Day 45)
Center of mass variability between groups
Time frame: Before rehabilitation (Day 1)
Center of mass variability between groups
Time frame: End of rehabilitation sessions (Day 45)
Mobility and balance between groups
Time frame: Before rehabilitation (Day 1)
Mobility and balance between groups
Time frame: End of rehabilitation sessions (Day 45)
Aerobic endurance and functional capacity between groups
Time frame: Before rehabilitation (Day 1)
Aerobic endurance and functional capacity between groups
Time frame: End of rehabilitation sessions (Day 45)
Fall risk between groups
Time frame: Before rehabilitation (Day 1)
Fall risk between groups
Time frame: End of rehabilitation sessions (Day 45)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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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.
Eric Pantera principal investigator
CHU de Nimes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Standard rehabilitation in people with Amputees / Rehabilitation and Virtual Reality, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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 6 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Pantera (04 66 02 25 36, eric.pantera@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mediolateral instability during mediolateral external perturbation between groups (time frame: Before rehabilitation (Day 1)). The study lists 2 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 25 Jun 2026.