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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality

    Other intervention

    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 intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Virtual Reality groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Before rehabilitation (Day 1)
2

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

Time frame
End of rehabilitation sessions (Day 45)

Secondary outcomes

1

Step length variability between groups

Meters, measured with the GRAIL rehabilitation and movement analysis platform

Time frame
Before rehabilitation (Day 1)
2

Step length variability between groups

Meters, measured with the GRAIL rehabilitation and movement analysis platform

Time frame
End of rehabilitation sessions (Day 45)
3

Step width variability between groups

Meters, measured with the GRAIL rehabilitation and movement analysis platform

Time frame
Before rehabilitation (Day 1)
4

Step width variability between groups

Meters, measured with the GRAIL rehabilitation and movement analysis platform

Time frame
End of rehabilitation sessions (Day 45)

Other outcomes

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