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NCT Number: NCT06424249

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes, Hôpital du Grau du Roi, Le Grau-du-Roi, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality

Other

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

Other

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.

Primary outcomes

  1. 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

  2. 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

  1. Step length variability between groups

    Time frame: Before rehabilitation (Day 1)

    Meters, measured with the GRAIL rehabilitation and movement analysis platform

  2. Step length variability between groups

    Time frame: End of rehabilitation sessions (Day 45)

    Meters, measured with the GRAIL rehabilitation and movement analysis platform

  3. Step width variability between groups

    Time frame: Before rehabilitation (Day 1)

    Meters, measured with the GRAIL rehabilitation and movement analysis platform

  4. Step width variability between groups

    Time frame: End of rehabilitation sessions (Day 45)

    Meters, measured with the GRAIL rehabilitation and movement analysis platform

  5. Cadence variability between groups

    Time frame: Before rehabilitation (Day 1)

    Steps/minute, measured with the GRAIL rehabilitation and movement analysis platform

  6. Cadence variability between groups

    Time frame: End of rehabilitation sessions (Day 45)

    Steps/minute, measured with the GRAIL rehabilitation and movement analysis platform

  7. Center of mass variability between groups

    Time frame: Before rehabilitation (Day 1)

    Meters, measured with the GRAIL rehabilitation and movement analysis platform

  8. Center of mass variability between groups

    Time frame: End of rehabilitation sessions (Day 45)

    Meters, measured with the GRAIL rehabilitation and movement analysis platform

  9. Mobility and balance between groups

    Time frame: Before rehabilitation (Day 1)

    Time Up and Go test, seconds

  10. Mobility and balance between groups

    Time frame: End of rehabilitation sessions (Day 45)

    Time Up and Go test, seconds

  11. Aerobic endurance and functional capacity between groups

    Time frame: Before rehabilitation (Day 1)

    2-minute walk test, meters

  12. Aerobic endurance and functional capacity between groups

    Time frame: End of rehabilitation sessions (Day 45)

    2-minute walk test, meters

  13. Fall risk between groups

    Time frame: Before rehabilitation (Day 1)

    Berg scale, score between 0 and 56 (no fall risk)

  14. Fall risk between groups

    Time frame: End of rehabilitation sessions (Day 45)

    Berg scale, score between 0 and 56 (no fall risk)

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Pantera

CONTACT

[email protected]

04 66 02 25 36

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: EQUIL-ARC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 22, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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