Robotic-assisted Therapy to Improve Manual Dexterity in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This is an intervention study including a baseline data collection, 6 weeks of robot-assisted
      training targeting hand dexterity, and a post-intervention data collection. The study will be
      conducted in the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital, Boston, MA.
      This study aims to assess the effectiveness of a robot-assisted training on hand dexterity
      and quality of life in children with cerebral palsy. Additionally, the investigators will
      study the relationship between muscle synergies and the outcomes of robot-assisted training.
    

Detailed description: 
      Participants will be assessed 2 times - before and after training with the robot. All the
      testing and training will be done at Spaulding Rehabilitation Hospital and will include:

      Clinical tests:

        -  A physical examination during which the investigators will measure range of motion and
           muscular strength at the shoulder, elbow, forearm, wrist, and fingers.

        -  A test to assess spasticity at the shoulder, elbow, forearm, and wrist.

        -  A test to evaluate upper extremity function.

        -  A test to assess unilateral gross manual dexterity.

        -  A test to assess quality of life (social wellbeing and acceptance, feelings about
           functioning, participation and physical health, emotional wellbeing and self-esteem,
           access to service, pain and impact of disability, and family health).

      Muscle activity tests:

      • A test to get detailed measures of how well participant can perform movements. The measures
      collected will include the movements of fingers, hands, and arms while picking up different
      objects. Movements will be tracked by attaching small reflective markers to the fingers,
      hands, and arms of the participant. Special cameras will be used to collect data. Special
      sensors (called electromyographic - EMG - sensors) will be attached to the hands and arms to
      tell the investigators when and how muscles are recruited to generate the movements.

      Training with the Robot:

      Study participants will undergo robot-assisted training for 18 times - up to 4 times per week
      during a period of approximately 7 weeks. The training sessions will be carried out by
      trained study staff. The robot will assist study participants to perform the movements while
      they attempt to move their fingers to control computer games. The assistance provided by the
      robot will be adjusted to the ability of each participant to move their hand. Each training
      session will last about 1 hour. This will include about 20 minutes of stretching exercises,
      setup time, and warm-up exercises. Study participants will be encouraged to ask for rest
      breaks whenever needed. The investigators will closely monitor study participants during all
      study sessions.
    

Intervention name(s): Robotic-assisted training of the hand
Intervention type(s): Device
Intervention description(s): Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant's fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Other intervention name(s): Amadeo® - Tyromotion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CP; Cerebral Palsy; Robotic; Hand; Rehabilitation