## Protocol Section
### Identification Module
**NCT ID:** NCT06424249

**Acronym:** EQUIL-ARC

**Brief Title:** Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation

**Official Title:** Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation

#### Organization Study ID Info
**ID:** Local/2023/EP-02
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nīmes
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Nīmes

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Amputees / Rehabilitation

- Virtual Reality

- Postural Balance

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Virtual Reality

**Label:** Virtual Reality group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Standard rehabilitation

**Label:** Control group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Virtual Reality group

**Description:** 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

**Name:** Virtual Reality

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** 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.

**Name:** Standard rehabilitation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Mediolateral instability during mediolateral external perturbation between groups

**Time Frame:** Before rehabilitation (Day 1)

**Description:** 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

**Measure:** Mediolateral instability during mediolateral external perturbation between groups

**Time Frame:** End of rehabilitation sessions (Day 45)

#### Secondary Outcomes

**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform

**Measure:** Step length variability between groups

**Time Frame:** Before rehabilitation (Day 1)

**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform

**Measure:** Step length variability between groups

**Time Frame:** End of rehabilitation sessions (Day 45)

**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform

**Measure:** Step width variability between groups

**Time Frame:** Before rehabilitation (Day 1)

**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform

**Measure:** Step width variability between groups

**Time Frame:** End of rehabilitation sessions (Day 45)

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

**Measure:** Cadence variability between groups

**Time Frame:** Before rehabilitation (Day 1)

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

**Measure:** Cadence variability between groups

**Time Frame:** End of rehabilitation sessions (Day 45)

**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform

**Measure:** Center of mass variability between groups

**Time Frame:** Before rehabilitation (Day 1)

**Description:** Meters, measured with the GRAIL rehabilitation and movement analysis platform

**Measure:** Center of mass variability between groups

**Time Frame:** End of rehabilitation sessions (Day 45)

**Description:** Time Up and Go test, seconds

**Measure:** Mobility and balance between groups

**Time Frame:** Before rehabilitation (Day 1)

**Description:** Time Up and Go test, seconds

**Measure:** Mobility and balance between groups

**Time Frame:** End of rehabilitation sessions (Day 45)

**Description:** 2-minute walk test, meters

**Measure:** Aerobic endurance and functional capacity between groups

**Time Frame:** Before rehabilitation (Day 1)

**Description:** 2-minute walk test, meters

**Measure:** Aerobic endurance and functional capacity between groups

**Time Frame:** End of rehabilitation sessions (Day 45)

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

**Measure:** Fall risk between groups

**Time Frame:** Before rehabilitation (Day 1)

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

**Measure:** Fall risk between groups

**Time Frame:** End of rehabilitation sessions (Day 45)

### Eligibility Module

**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.
* 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.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** eric.pantera@chu-nimes.fr

**Name:** Eric Pantera

**Phone:** 04 66 02 25 36

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nîmes

**Contacts:**

***Contact 1:***

- **Email:** drc@chu-nimes.fr

- **Name:** Anissa Megzari

- **Phone:** 04.66.68.42.36

- **Role:** CONTACT

***Contact 2:***

- **Name:** Eric Pantera

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Nicolas Reneaud

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Antoine Brisset

- **Role:** SUB_INVESTIGATOR

**Country:** France

**Facility:** CHU de Nimes

#### Overall Officials

**Official 1:**

**Affiliation:** CHU de Nimes

**Name:** Eric Pantera

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
