New Technology for Individualised, Intensive Training of Gait After Stroke- Study II
Condition: Stroke; Ambulation Difficulty; Hemiparesis
MeSH terms: Stroke; Paresis; Mobility Limitation
Study type: Interventional

Summary: 
      The overall purpose of this project is to establish the added value of training with the
      Hybrid Assistive Limb (HAL) exoskeleton system as part of regular rehabilitation intervention
      programs after stroke.

      The main specific aims are:

      (i) to compare potential effects on functioning and disability of gait and mobility training
      long-term after stroke by comparing A) HAL-training combined with conventional rehabilitation
      interventions to B) conventional rehabilitation interventions without HAL and to C) no
      intervention.
    

Detailed description: 
      The effectiveness of the interventions will be assessed in terms aspects of body function,
      walking ability and endurance as well as level of activity in daily living and participation
      assessed at the end of intervention and at a 6 and 12 months follow-up.

      Intensive gait training with HAL is performed 1 session/day, 3 days/week for 6 weeks and each
      session will not exceed 60 min of effective walking time with HAL. In addition, each session
      will include conventional gait training that will not exceed 30 min effective training time.
      To standardize the training procedure, training with HAL is performed on a treadmill and to
      enable body weight support. Body weight support is used to prevent falls and to unburden the
      weight of the suit (9 kg). The training program is performed by physiotherapists, trained in
      the HAL method and the study procedures. At the end of the 6 weeks, the physiotherapist that
      has been engaged in the patient's conventional training will perform 1-2 home visits to
      inform/educate the patient and those who are providing assistance to the patient in how the
      patient can make use of any gains in gait function during activities of daily living.

      The 1st control group will receive conventional gait training performed 1 session/day, 3
      days/week for 6 weeks that will not exceed 1h 30 min effective training time.

      The 2nd control group will not receive an intervention. The conventional gait training is
      performed according to current best evidence based practice and may include over ground
      walking with assistance and/or assistant devices as well as the use of a treadmill and body
      weight support and training of gait function in activities of daily living
    

Intervention name(s): Hybrid Assistive Limb (HAL); 1st control group; 2nd control group
Intervention type(s): Device; Other; Other
Intervention description(s): Intensive gait training with Hybrid Assistive Limb (HAL) is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time.; Conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.; The 2nd control group will not receive an intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Robotics