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Clinical Trials/NCT06424249
NCT06424249
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire de Nīmes2 sites in 1 country20 target enrollmentOctober 14, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amputees / Rehabilitation
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
20
Locations
2
Primary Endpoint
Mediolateral instability during mediolateral external perturbation between groups
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 14, 2024
End Date
June 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Cadence variability between groups(End of rehabilitation sessions (Day 45))
  • Step width variability between groups(End of rehabilitation sessions (Day 45))
  • Fall risk between groups(End of rehabilitation sessions (Day 45))
  • Step length variability between groups(End of rehabilitation sessions (Day 45))
  • Center of mass variability between groups(End of rehabilitation sessions (Day 45))
  • Mobility and balance between groups(End of rehabilitation sessions (Day 45))
  • Aerobic endurance and functional capacity between groups(End of rehabilitation sessions (Day 45))

Study Sites (2)

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