Rehabilitation medicine in countries of Central/Eastern Europe.
Reuben Eldar, Lajos Kullmann, Crt Marincek...
https://pubmed.ncbi.nlm.nih.gov/17852214/Actively Recruiting
Led by Wandercraft · Updated on 2024-08-06
100
Participants Needed
1
Research Sites
N/A
Total Duration
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
Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and / or Deficiencies in Adult Population
R
Rebecca Sauvagnac, MD
D
Dijana Nuic, Ph.D
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Wandercraft
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Lead Sponsor