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NCT Number: NCT05753800

Efficacy of INTORUS as a Therapeutic Tool in Motor Intervention in Patients at Aspace Centres in the Province of Cáceres

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.

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Key information

Conditions

Cerebral Palsy Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Mental Disorders Motor Activity Motor Disorders Nervous System Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blanca González Sánchez

Cáceres, Caceres, 10001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INTORUS

Device

Motor intervention protocol with Intorus consisting of a series of exercises of progressive difficulty

Primary outcomes

  1. IMPROVEMENT OF UPPER LIMB MOBILITY AS MEASURED BY GONIOMETER

    Time frame: Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).

    Measuring joint amplitude of upper limb joints with goniometer

Secondary outcomes

  1. Functional Gesture of Activities of Daily Living

    Time frame: Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).

    Measurement of the performance of a functional gesture performed in the patient's activities of daily living.

Other outcomes

  1. Professional satisfaction questionnaire

    Time frame: Through study completion, an average of 6 months

    Measurement of professionals' satisfaction with the use of the tool measured with a questionnaire designed by ourselves.

  2. Participants satisfaction questionnaire

    Time frame: Through study completion, an average of 6 months

    Measurement of participants' satisfaction with the use of the tool measured with a questionnaire designed by us.

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

Efficacy of the INTORUS Device as a Therapeutic Tool in Motor Intervention

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2023
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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