Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation

Virtual Reality Clinical Trial

— EQUIL-ARC  

Official title:

Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424249
• Other study ID #: Local/2023/EP-02
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Postural Balance
• Virtual Reality

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)