Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06424249

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

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-05-01

20

Participants Needed

2

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Unilateral transtibial amputees hospitalized in musculoskeletal system rehabilitation
  • All causes including vascular, traumatic, and septic
  • Have vascular equipment approved by a physician
  • Able to walk for 5 minutes on a treadmill without technical help
  • Provided free and informed consent by signing the consent form
  • Covered by a health insurance plan
Not Eligible

You will not qualify if you...

  • Participating in another interventional study or within exclusion period from a previous study
  • Already included in this study
  • Refuse or unable to sign consent
  • Unable to receive informed information
  • Under legal protection such as guardianship
  • Have untreated or uncorrected visual disorders
  • Have major cognitive disorders (MOCA >23)
  • Have vestibular disorders
  • Have uncontrolled epilepsy
  • Have an unhealed amputation stump
  • Weigh more than 135kg or less than 20kg
  • Have functional ambulation category 1 or less, requiring firm continuous assistance
  • Taking medications that affect exercise tolerance
  • Have sensory impairments
  • Have significantly reduced bone density
  • Unable to properly adjust harness due to body shape, colostomy bags, skin lesions, or other reasons
  • Pregnant, giving birth, or breastfeeding
  • Develop stump wounds requiring discharge during study
  • Have more than 50% absence from rehabilitation sessions
  • Need a new prosthesis insert
  • Experience serious adverse events affecting dynamic balance rehabilitation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

CHU de Nîmes, Hôpital du Grau du Roi

Le Grau-du-Roi, France, 30240

Actively Recruiting

2

CHU de Nimes

Nîmes, France

Not Yet Recruiting

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Research Team

E

Eric Pantera

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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