Actively Recruiting
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of a virtual reality protocol on dynamic balance in people with a unilateral transtibial amputation during initial rehabilitation. The study compares this approach with a conventional rehabilitation protocol to see if virtual reality can improve dynamic balance assessment criteria. The importance of proprioceptive re-education for dynamic balance is highlighted, as improved gait and prosthesis use can enhance autonomy for amputees. Participants will be randomly assigned to one of two groups. The experimental group will follow a progressive rehabilitation program using virtual and augmented reality exercises combined with mechanical treadmill perturbations, virtual environment interaction, and biofeedback to modify gait patterns. The control group will participate in a treadmill walking protocol immersed in virtual reality but without disturbances or prompts to change walking. During the 45-day rehabilitation period, assessments will be conducted before the start and at the end of the sessions. Researchers will measure mediolateral instability, step variability, cadence, center of mass variability, mobility, balance, aerobic endurance, functional capacity, and fall risk. Data collection will include dynamic balance tests and gait analysis to monitor progress and rehabilitation outcomes.
CONDITIONS
Brief Title
Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral transtibial amputees hospitalized for musculoskeletal rehabilitation
- All causes: vascular, traumatic, and septic
- Use of vascular equipment approved by a physician
- Able to walk on a treadmill for 5 minutes without technical help
- Provided free and informed consent and signed consent form
- Member or beneficiary of a health insurance plan
You will not qualify if you...
- Participating in another interventional drug or device study or within exclusion period from previous study
- Already included in this study
- Refusal or inability to sign consent
- Unable to receive informed information
- Under legal protection such as guardianship
- Uncorrected or untreated visual disorders
- Major cognitive disorders (MOCA >23)
- Vestibular disorders
- Uncontrolled epilepsy
- Unhealed amputation stump
- Weight over 135 kg or under 20 kg
- Functional ambulation category 1 or less (requires firm, continuous assistance)
- Taking medication affecting exercise tolerance
- Sensory impairments
- Significantly reduced bone density
- Inability to properly fit harness due to body shape, colostomy bags, skin lesions, or other reasons
- Pregnant, giving birth, or breastfeeding
- Stump wound appearing during study requiring discharge
- More than 50% missed rehabilitation sessions
- Need for new prosthesis insert
- Serious adverse event affecting dynamic balance rehabilitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 45 days
Participants receive either virtual reality-based rehabilitation involving interactive exercises and biofeedback or standard treadmill rehabilitation without disturbances, aiming to improve dynamic balance and gait.
Approximately 15 rehabilitation sessions over 45 days
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
Research Team
E
Eric Pantera
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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