Actively Recruiting
Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
Led by Wandercraft · Updated on 2025-02-04
66
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of early and intense walking sessions assisted by the Atalante exoskeleton in patients with hemiparesis who have poor or no ability to walk (Functional Ambulation Category score of 0 or 1) between one and four months after a stroke. This trial compares the recovery of walking ability between patients using the exoskeleton plus conventional therapy and those receiving only conventional therapy. The goal is to see if more patients reach a walking ability score of 4 or higher after the intervention period. Participants are divided into two groups for a 6-week intervention. The Exo group will have three one-hour sessions per week using the Atalante exoskeleton combined with two conventional therapy sessions weekly, totaling 18 exoskeleton and 12 conventional sessions. The Control group will receive five conventional therapy sessions per week, totaling 30 one-hour sessions. Conventional therapy includes physiotherapy tasks such as limb practice and walking exercises. During the study, participants will be assessed on walking recovery without the exoskeleton, using measures like the Functional Ambulation Category score, walking speed, balance tests, muscle flexibility, and quality of life questionnaires. These assessments occur at multiple timepoints including the start, end of intervention, hospital discharge, and six months post-stroke. Researchers will also monitor anxiety, depression, patient and therapist satisfaction, and workload during sessions. The total study duration includes the 6-week intervention and follow-ups extending to six months.
CONDITIONS
Brief Title
Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be older than 18 years
- Have a first significant disability caused by stroke
- Have hemiparesis in the acute to subacute phase, between 1 and 4 months after stroke
- Have a Functional Ambulation Category score less than 2
- Have health insurance coverage
- Be informed and willing to sign an approved consent form, or have an impartial witness sign if unable
You will not qualify if you...
- Muscle overactivity in key leg muscles that prevents exoskeleton use, as judged by a clinician
- Recent bone fracture within the last 3 months or therapy causing secondary osteoporosis
- Severe joint pain in lower limbs that interferes with participation
- Pressure sores grade I or higher where the exoskeleton contacts the body
- Medical conditions that contraindicate medium intensity physical exercise
- Orthostatic hypotension causing a drop of more than 20 mmHg systolic blood pressure after 3 minutes standing
- Uncontrolled seizures
- Physical body features preventing use of the Atalante device
- Pregnancy
- Inability to provide informed consent or being in detention
- Participation in another interventional trial at the same time
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive either sessions with the Atalante exoskeleton combined with conventional therapy or conventional therapy alone to improve gait recovery after stroke.
3 visits per week for the exoskeleton group and 5 visits per week for the control group
Duration - Up to 6 months post stroke
Participants are assessed for walking recovery, muscle function, balance, anxiety and depression, quality of life, and satisfaction up to 6 months post stroke.
Visits at discharge and at 6 months post stroke
Trial Site Locations
Total: 5 locations
1
Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier
Créteil, France
Actively Recruiting
2
Centre de Médecine Physique et de Réadaptation APAJH de Pionsat
Pionsat, France
Actively Recruiting
3
Schön Klinik
Bad Aibling, Germany
Not Yet Recruiting
4
Vivantes Klinikum Spandau
Berlin, Germany
Actively Recruiting
5
Institut Guttmann
Barcelona, Spain
Actively Recruiting
Research Team
D
Dr Rebecca Sauvagnac, MD
L
Laure Bouché
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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