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

Not Applicable

Recruiting

• Conditions: Postural Balance; Amputees / Rehabilitation; Virtual Reality
• Interventions: Other: Standard rehabilitation; Other: Virtual Reality

• Registration Number: NCT06424249
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-22
• Study Start: 2024-10-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standard rehabilitation	-
Virtual Reality group	Virtual Reality	-

Primary Outcome Measures

Name	Time	Method
Mediolateral instability during mediolateral external perturbation between groups	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 Outcome Measures

Name	Time	Method
Cadence variability between groups	End of rehabilitation sessions (Day 45)	Steps/minute, measured with the GRAIL rehabilitation and movement analysis platform
Step width variability between groups	End of rehabilitation sessions (Day 45)	Meters, measured with the GRAIL rehabilitation and movement analysis platform
Fall risk between groups	End of rehabilitation sessions (Day 45)	Berg scale, score between 0 and 56 (no fall risk)
Step length variability between groups	End of rehabilitation sessions (Day 45)	Meters, measured with the GRAIL rehabilitation and movement analysis platform
Center of mass variability between groups	End of rehabilitation sessions (Day 45)	Meters, measured with the GRAIL rehabilitation and movement analysis platform
Mobility and balance between groups	End of rehabilitation sessions (Day 45)	Time Up and Go test, seconds
Aerobic endurance and functional capacity between groups	End of rehabilitation sessions (Day 45)	2-minute walk test, meters

Trial Locations

Locations (2)

CHU de Nîmes, Hôpital du Grau du Roi; 🇫🇷 Le Grau-du-Roi, France

CHU de Nimes; 🇫🇷 Nîmes, France