Robotic Rehabilitation of Cerebral Palsy
Condition: Spastic Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of the study is to examine the outcomes of home-based robot-guided therapy and
      compare it to laboratory-based robot-guided therapy for impaired ankles in cerebral palsy.
      Children with spastic cerebral palsy (CP) are randomly placed into two groups, participating
      in robot-guided stretching and active movement training either in a research lab setting (Lab
      group) or in a home setting (Home group).
    

Detailed description: 
      Children with spastic CP will be randomly placed to 2 groups, either a Lab group or a Home
      group. For both groups, the participation will involve 18 training sessions over 6 weeks with
      3 sessions each week. Each training session will last about 45 minutes, including stretching
      and active movement training.

      The participant will be asked to sit with the foot secured to a footplate and leg fixed by a
      leg-support. Once the rehab robot is on the child's ankle, the investigator will first
      determine maximum range of motion that is safe for the ankle stretching. The robot will then
      move the ankle joint slowly within the set range of motion, and stretch the ankle back and
      forth. The passive stretching will help loosen the child's muscle and increase range of
      motion in the ankle joint. Passive stretching will last about 15 minutes.

      After stretching, the investigator will ask the child to move and control the ankle joint
      back and forth to complete video-game tasks. While the child moves the ankle, the robot will
      provide assistance or resistance to improve control of the ankle joint. Active movement
      training will last about 20 minutes.

      For Home group, the family members will be trained by the research team at the lab on how
      they use the rehab robot properly. On the day of the first assessment, the investigator will
      go through the device operation with family members. A detailed user manual will be given.
      The investigator will allow the family members and the child to practice using the device as
      many times as needed until the participant feel comfortable using the device at home. The
      family members should prepare for a minimum of one hour for this instructional period to
      learn the device, but they will be allowed as much time as needed.

      Before leaving UMB to begin at-home training, the family members will be checked for the
      competency of using the device. The family members will be asked to go through each step
      without any direct assistance with the research staff. The family members may use their own
      vehicle to take the portable rehab robot home. While the family members are doing training
      for the child at home, the training data will be saved automatically in the laptop with the
      rehab robot.

      Only one ankle joint will be allowed to treat using this robotic device. The investigator
      will choose the more impaired side ankle of the child to start the training. The investigator
      will follow up with the family members 1-3 times per week to check in regarding the child's
      participation and any issues during the training. The family members can also call the
      research staff if they have any questions about the training. The family members should
      follow the same training plan during 18 training sessions unless the investigator decide to
      adjust the training setups based on the child's progress.

      Outcome assessments

      During the study, the child will have 3 assessment visits in the research lab. The visits
      will occur before and after 6-week training, and at a follow-up 6 weeks after the training
      ends. During the assessment, the child's ankle will be moved by the robot to test passive
      range of motion and joint stiffness. The participant will also move the ankle himself and the
      active range of motion and muscle strength will be recorded. Clinical exam scales will be
      done including modified Ashworth scale, Selective Control Assessment of Lower Extremity
      (SCALE), balance, and walking ability (distance covered in 6 minutes).
    

Intervention name(s): IntelliStretch
Intervention type(s): Device
Intervention description(s): The impaired ankle of the participants are trained 3 times a week for 6 weeks in the lab or at home. The participants use the portable robotic device to stretch the ankle and increase range of motion (ROM). Then subjects use their gained ROM immediately in the active movement training to play video games and improve motor control.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral palsy; Ankle Impairments; Robotic rehabilitation