Efficacy of INTORUS as a Therapeutic Tool in Motor Intervention in Patients at Aspace Centres in the Province of Cáceres
Condition: Cerebral Palsy; Motor Disorders; Motor Activity
MeSH terms: Cerebral Palsy; Motor Disorders
Study type: Interventional

Summary: 
      The goal of this Clinical Trial is to verify the effectiveness of the use of the Intorus
      device in the motor intervention in patients with cerebral palsy and related syndromes. The
      main question it aims to answer is:

      Does the use of the Intorus tool manage to improve the mobility of upper limbs (MMSS) in
      patients with infantile cerebral palsy to increase their performance in activities of daily
      living? A total of approximately 50 users will participate in the study. Participants will be
      divided into two groups randomly. The control group will receive an intervention treatment at
      the motor level in the traditional way, following the protocols established in the center,
      and the intervention group will receive an intervention treatment at the motor level with the
      INTORUS device.

      Randomization will be carried out using the Oxford Minimization and Randomization software.
    

Detailed description: 
      The intervention program will take place during the Occupational Therapy sessions and will be
      carried out by the center's occupational therapists. These sessions must be carried out in a
      quiet environment, without distractions so that the user can concentrate on carrying out the
      activities. It is important that the patient attends the sessions in comfortable, sleeveless
      clothing, to allow the tool to slide smoothly through their upper limbs.

      Each session will consist of several exercises with their corresponding rest breaks.

      EVALUATION

      The evaluations will be carried out prior to the start of treatment, at 20 weeks of treatment
      and at 40 weeks of treatment once the intervention program has concluded.

      The tools used to carry out the evaluation will be:

        -  Questionnaire of sociodemographic variables

        -  Goniometric

             -  Shoulder joint: abduction-adduction, flexion-extension, external-internal rotation.

             -  Elbow joint: flexion-extension, pronation-supination.

             -  Wrist joint: flexion-extension, radial-ulnar deviation.

             -  Articulation of the thumb: abduction-adduction, flexion-extension, opposition.

             -  Articulation of the fingers: flexion-extension, abduction-adduction.

        -  Gross Motor Function Classification

        -  Assessment of a functional gesture

        -  Satisfaction questionnaire for professionals The evaluations will be carried out by a
           professional external to the center to avoid bias.

      Once the intervention period is over, a questionnaire will be passed to the professionals
      participating in the study to assess the usefulness of the device, the degree of satisfaction
      with it and the usefulness of the therapies applied.

      TIMELINE The intervention consists of 40 treatment sessions lasting 45 minutes each with a
      frequency of 2 days a week in which the intervention program described above will be
      developed.

      Previously, the participants will receive a "session 0" in which they will carry out a first
      contact with the device.
    

Intervention name(s): INTORUS
Intervention type(s): Device
Intervention description(s): Motor intervention protocol with Intorus consisting of a series of exercises of progressive difficulty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy; motor activity; motor disorders