Assessment of the Interest of the Atalante Device for Patients With Manual Wheelchairs
Condition: Complete Motor Paraplegia
MeSH terms: Paraplegia
Study type: Interventional

Summary: 
      The loss of standing and walking capabilities in a paraplegic person is most often the result
      of damage to the spinal cord, either traumatic (accidental) or pathological and has both a
      somatic and a psychological impact on the quality of life, the risk of depression, and the
      difficulty of socio-professional reintegration in a society that is not adapted to people
      with disabilities.

      A motorized mechanical exoskeleton is an external device intended to compensate for a
      muscular or neurological deficiency enabling paraplegics to stand and walk again. The
      Atalante exoskeleton, designed by Wandercraft company allows patients to stand upright and
      walk without the aid of crutches.

      This early study was the first clinical investigation of the Atalante exoskeleton performed
      early in the development. It was used to evaluate the device design concept with respect to
      initial clinical safety and device functionality and guided further device modifications.
    

Detailed description: 
      The aim of this study was to test the use of the Atalante exoskeleton on 10 patients with
      complete motor paraplegia (ASIA A and B) with a level of injury between T6 and S1.

      In this multi-centric clinical trial, patients were asked to perform between 1 and 2 days of
      training with Atalante exoskeleton including device training and evaluations (up to 9 hours
      of training and 3 hours of evaluation per patient).

      The primary objective of this study was to assess patients' ability to walk straight- for 10
      meters with the Atalante exoskeleton during 10-meters walk test (10MWT).

      Within-group differences between the Atalante exoskeleton and the usual walking aid used by
      the patient in the success rate of the 10MWT were compared by a McNemar test.

      The secondary objectives focused on performance evaluation with the Atalante exoskeleton. The
      assessments performed were:

        1. Assessment of the superiority of the Atalante exoskeleton compared to the usual aid
           walking assistance used by the patient on the walking, verticalization (or
           sit-to-stand), static and dynamic balance ability

        2. Assessment of the static and dynamic postural stability of the subject with the Atalante
           exoskeleton by observation of center of pressure displacement and velocity

        3. Assessment of the perceived effort by the patient

        4. Assessment of perceived safety by the patient

        5. Assessment of the overall satisfaction of patients after using the exoskeleton

        6. Comparison of the two types of walk on walking ability, perceived effort, and safety
    

Intervention name(s): Test with Atalante exoskeleton in "continuous walk" type
Intervention type(s): Device
Intervention description(s): The "continuous" walk is smoother and more physiologic than the "push and swing" walk
Other intervention name(s): Test with Atalante exoskeleton in "push and swing" walk type
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Prospective, multicentric, comparative, randomized cross-over study
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: exoskeleton; paraplegia; rehabilitation