BridgeMD
Compares treatment options for Amputees / Rehabilitation
Official title Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional Rehabilitation
ClinicalTrials.gov ID: NCT06424249
What this study is testing
- What it's testing
- Amputation causes somatic and psychological damage. Prognostic factors for postoperative gait recovery include the need for proprioceptive re-education for dynamic balance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- The subject is participating in an treatment study or one involving a drug or medical device, or is in a period of exclusion determined by a previous...
- 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.
See the full eligibility 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
- The subject is participating in an treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Le Grau-du-Roi, France
- Nîmes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Grau-du-Roi, France; Nîmes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.