Clinical trial NCT05753800: Efficacy of INTORUS as a Therapeutic Tool in Motor Intervention in Patients at Aspace Centres in the Province of Cáceres
Official title: Efficacy of the INTORUS Device as a Therapeutic Tool in Motor Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Motor Disorders
Motor Activity
Keywords: cerebral palsy
motor activity
motor disorders
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Users with infantile cerebral palsy and/or related syndromes.
* Ages between 4 and 18 years.
* Motor disability.
* Affectation in the mobility of upper limbs.
* Informed consent signed by parents/guardians.

Exclusion Criteria:

* Patients with another type of pathology not related to cerebral palsy.
* Under 4 years and over 18 years.
* Participants who do not meet the inclusion criteria described above

Primary outcomes:
measure: IMPROVEMENT OF UPPER LIMB MOBILITY AS MEASURED BY GONIOMETER
timeFrame: Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).
Secondary outcomes:
measure: Functional Gesture of Activities of Daily Living
timeFrame: Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).
Other outcomes:
measure: Professional satisfaction questionnaire
timeFrame: Through study completion, an average of 6 months
measure: Participants satisfaction questionnaire
timeFrame: Through study completion, an average of 6 months
Locations:
city: Cáceres
country: Spain
facility: Blanca González Sánchez
state: Caceres
Study officials:
affiliation: Universidad de Extremadura
name: Blanca González Sánchez, Doctor
role: PRINCIPAL_INVESTIGATOR
References: