Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06538974

Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population

Led by Wandercraft · Updated on 2024-08-06

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate a long-term outpatient rehabilitation program using the Atalante X exoskeleton for adults with lower limb weakness or deficiencies caused by various conditions such as stroke, spinal cord injury, or neurodegenerative diseases. It addresses challenges in current rehabilitation care, like long wait times and limited accessibility, by exploring the potential benefits of robotic-assisted therapy over an extended period. Participants will engage in at least one exoskeleton rehabilitation session weekly during a 12-month intervention phase. These sessions involve ambulatory exercises with the Atalante X device, with intensity gradually increasing over time. After the initial year, participants may choose to continue in a voluntary extension phase for an additional year, following the same rehabilitation protocol. Throughout the study, participants will undergo assessments at the start, after 4 and 12 months, and for those in the extension phase, also at 16 and 24 months. These evaluations include tests of sitting function, walking ability, balance, muscle strength, cognitive function, and quality of life, along with monitoring of adverse events. The program also tracks detailed session data such as number of steps, session duration, and device assistance levels to understand adherence and impacts on motor and cognitive functions over time.

CONDITIONS

Brief Title

Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient suffering from lower limb weaknesses and/or deficiencies regardless of the cause
  • Adult patient 18 years old or older
  • Patient able to read and write in French and who have signed an informed consent form
  • Patient affiliated to a social security system
Not Eligible

You will not qualify if you...

  • Individuals with severe spasticity of adductor muscles, hamstring, quadriceps, and triceps surae (score of 4 on the modified Ashworth scale)
  • Pregnant women
  • Individuals with a history of osteoporotic fracture and/or pathology or treatment causing secondary osteoporosis
  • Pressure ulcers of Grade I or higher in areas contacting the exoskeleton
  • Severe aphasia limiting ability to express needs or complete questionnaires
  • Patients with cardiac or respiratory contraindications to physical exertion
  • Patients unable to provide consent
  • Patients under legal protection
  • Patients participating in another study simultaneously
  • Patients with morphological contraindications to the use of the Atalante X exoskeleton except specific allowed joint angles (knee, ankle, hip) restrictions as per user manual guidelines

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 year

Participants use the hands-free exoskeleton device to perform ambulatory exercises with gradual intensity increase during sessions lasting up to one year, with at least one session per week.

Weekly sessions with the exoskeleton

Follow-up

Duration - Up to 1 additional year

Participants may continue voluntary exoskeleton sessions following the initial intervention year, with ongoing assessments and monitoring.

Weekly sessions with the exoskeleton

Trial Site Locations

Total: 1 location

1

Wandercraft

Paris, France, 75004

Actively Recruiting

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Research Team

R

Rebecca Sauvagnac, MD

D

Dijana Nuic, Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

Global estimates of the need for rehabilitation based on the Global Burden of Disease study 2019: a systematic analysis for the Global Burden of Disease Study 2019.

Alarcos Cieza, Kate Causey, Kaloyan Kamenov...

https://pubmed.ncbi.nlm.nih.gov/33275908