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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06424249
Other study ID # Local/2023/EP-02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date December 2024

Study information

Verified date May 2024
Source Centre Hospitalier Universitaire de Nimes
Contact Eric Pantera
Phone 04 66 02 25 36
Email eric.pantera@chu-nimes.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual Reality
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 rehabilitation
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.

Locations

Country Name City State
France CHU de Nimes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Before rehabilitation (Day 1)
Primary 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 End of rehabilitation sessions (Day 45)
Secondary Step length variability between groups Meters, measured with the GRAIL rehabilitation and movement analysis platform Before rehabilitation (Day 1)
Secondary Step length variability between groups Meters, measured with the GRAIL rehabilitation and movement analysis platform End of rehabilitation sessions (Day 45)
Secondary Step width variability between groups Meters, measured with the GRAIL rehabilitation and movement analysis platform Before rehabilitation (Day 1)
Secondary Step width variability between groups Meters, measured with the GRAIL rehabilitation and movement analysis platform End of rehabilitation sessions (Day 45)
Secondary Cadence variability between groups Steps/minute, measured with the GRAIL rehabilitation and movement analysis platform Before rehabilitation (Day 1)
Secondary Cadence variability between groups Steps/minute, measured with the GRAIL rehabilitation and movement analysis platform End of rehabilitation sessions (Day 45)
Secondary Center of mass variability between groups Meters, measured with the GRAIL rehabilitation and movement analysis platform Before rehabilitation (Day 1)
Secondary Center of mass variability between groups Meters, measured with the GRAIL rehabilitation and movement analysis platform End of rehabilitation sessions (Day 45)
Secondary Mobility and balance between groups Time Up and Go test, seconds Before rehabilitation (Day 1)
Secondary Mobility and balance between groups Time Up and Go test, seconds End of rehabilitation sessions (Day 45)
Secondary Aerobic endurance and functional capacity between groups 2-minute walk test, meters Before rehabilitation (Day 1)
Secondary Aerobic endurance and functional capacity between groups 2-minute walk test, meters End of rehabilitation sessions (Day 45)
Secondary Fall risk between groups Berg scale, score between 0 and 56 (no fall risk) Before rehabilitation (Day 1)
Secondary Fall risk between groups Berg scale, score between 0 and 56 (no fall risk) End of rehabilitation sessions (Day 45)
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