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

NCT06538974 | Recruiting

• 1 other identifier: CIP005 ALERT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In 2019, approximately 2.4 billion people worldwide required rehabilitation for various health pathologies, a 63% increase since 1990. It has been suggested that current rehabilitation frameworks (inpatient, outpatient, and community-based) are insufficient to meet local population needs due to issues like long waiting times, lack of facilities, prioritization, funding, and accessibility.Patients with lower limb weaknesses, resulting from various conditions (for example stroke, traumatic brain injury, spinal cord injury and others) require long-term management and motivation for engagement, which are crucial for functional outcomes. This highlights the need for sustainable gait and balance rehabilitation. New technologies like exoskeletons have shown promising results in short-term inpatient programs, improving gait, balance, and quality of life, however, long-term follow-up data are still needed. The present clinical investigation is a national, prospective, open-label interventional trial, proposing a 12-month outpatient rehabilitation program with the Atalante X exoskeleton to treat lower limb weakness and/or impairments in 100 participants. The rehabilitation program consists of at least one exoskeleton rehabilitation session per week. At the end of the first-year experimental phase, participants can continue for an additional year in the voluntary phase. The program aims to explore the potential long-term effects of supervised robotic rehabilitation on motor, cognitive, bowel, bladder functions, quality of life, and well-being. Assessments are conducted at baseline, after 4 and 12 months of exoskeleton rehabilitation, and at 16 and 24 months for participants in the voluntary phase.

Conditions

Motor Disorders; Gait Disorders, Neurologic; Neurodegenerative Diseases; Spinal Cord Injuries; Weakness, Muscle; Cerebrovascular Accident

Keywords

Hands-free Exoskeleton; Atalante X; Gait; Balance; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Function in Sitting Test

  The Function in Sitting Test consists of 14 items, each scored on a scale from 0 to 4, where 0 indicates the lowest ability and 4 represents normal sitting abilities. The maximum achievable score is 56, reflecting normal ability.

  At baseline, at 4 and 12 months; at 16 and 24 months

Secondary Outcomes (29)

• 10-meter walk test

  At baseline, at 4 and 12 months; at 16 and 24 months

• Modified Clinical Test of Sensory Integration in Balance

  At baseline, at 4 and 12 months; at 16 and 24 months

• Timed Up and Go

  At baseline, at 4 and 12 months; at 16 and 24 months

• Functional Independence Measure

  At baseline, at 4 and 12 months; at 16 and 24 months

• 6-minute walk test

  At baseline, at 4 and 12 months; at 16 and 24 months

Study Arms (1)

Hands-free exoskeleton

EXPERIMENTAL

Device: Hands-free exoskeleton

Interventions

Hands-free exoskeleton DEVICE

During the one-year intervention period, participants will complete at least one exoskeleton session per week (≥36 sessions) with the Atalante X. The additional voluntary year follows the same design. During sessions with the exoskeleton, the patients will perform ambulatory exercises with the device, with a gradual increase of intensity through the sessions.

Hands-free exoskeleton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient suffering from lower limb weaknesses and / or deficiencies regardless of the cause
• Adult patient ≥18 years old
• Patient able to read and write in French and who have signed an informed consent form
• Patient affiliated to a social security system.

You may not qualify if:

• Individual with severe spasticity of adductor muscles, hamstring, quadriceps and triceps surae. Severe spasticity is defined by a score of 4 on the modified Ashworth scale
• Pregnant woman
• Individual with history of osteoporotic fracture and / or pathology or treatment causing secondary osteoporosis
• Pressure Ulcer of Grade I or higher according to the NPUAP International Pressure Ulcer Classification System- EPUAP, in areas of contact with the Atalante X system
• Severe aphasia limiting ability to express needs or to fulfil questionnaires, at the discretion of the physician.
• Patient with a cardiac or respiratory contraindication to physical exertion, at discretion of the physician
• Patient unable to deliver his/her consent
• Patient under legal protection
• Patient participating at the same time in another study
• Patients with morphological contraindications to the use of the Atalante X exoskeleton (as per user's manual) with exceptions as follows: knee flessum of 20° authorized if sensibility is present; equinus of the ankle of 20° allowed regardless of presence or absence of sensibility, hip flessum of 20° allowed regardless of presence or absence of sensibility.

Sponsors & Collaborators

• Wandercraft: lead

Study Sites (1)

Wandercraft

Paris, 75004, France

RECRUITING

Related Publications (3)

• Cieza A, Causey K, Kamenov K, Hanson SW, Chatterji S, Vos T. 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. Lancet. 2021 Dec 19;396(10267):2006-2017. doi: 10.1016/S0140-6736(20)32340-0. Epub 2020 Dec 1.

  PMID: 33275908 BACKGROUND

• Eldar R, Kullmann L, Marincek C, Sekelj-Kauzlaric K, Svestkova O, Palat M. Rehabilitation medicine in countries of Central/Eastern Europe. Disabil Rehabil. 2008;30(2):134-41. doi: 10.1080/09638280701191776.

  PMID: 17852214 BACKGROUND

• Kamenov K, Mills JA, Chatterji S, Cieza A. Needs and unmet needs for rehabilitation services: a scoping review. Disabil Rehabil. 2019 May;41(10):1227-1237. doi: 10.1080/09638288.2017.1422036. Epub 2018 Jan 5.

  PMID: 29303004 BACKGROUND

MeSH Terms

Conditions

Motor Disorders; Gait Disorders, Neurologic; Neurodegenerative Diseases; Spinal Cord Injuries; Muscle Weakness; Stroke

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathologic Processes; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rebecca Sauvagnac, MD

  Wandercraft

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Sauvagnac, MD

CONTACT

+33 (0)1 79 35 31 09; rebecca.sauvagnac@wandercraft.health

Dijana Nuic, Ph.D

CONTACT

+33 (0)1 79 35 31 09; dijana.nuic@wandercraft.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Adult patients presenting lower limb weakness and / or deficiencies, regardless of the underlying causes

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: August 6, 2024
• Study Start: February 16, 2023
• Primary Completion (Estimated): July 2, 2027
• Study Completion (Estimated): July 2, 2027
• Last Updated: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)