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

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Motor Activity; Motor Disorders
• Intervention / Treatment: Device: INTORUS

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Caceres
    • Cáceres, Caceres, Spain, 10001
      • Blanca Gonzalez Sanchez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; This group receives motor intervention sessions with the Intorus device	Device: INTORUS; Motor intervention protocol with Intorus consisting of a series of exercises of progressive difficulty
No Intervention: Control group; This group receives no motor intervention sessions with the Intorus device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IMPROVEMENT OF UPPER LIMB MOBILITY AS MEASURED BY GONIOMETER	Measuring joint amplitude of upper limb joints with goniometer	Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Gesture of Activities of Daily Living	Measurement of the performance of a functional gesture performed in the patient's activities of daily living.	Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Professional satisfaction questionnaire	Measurement of professionals' satisfaction with the use of the tool measured with a questionnaire designed by ourselves.	Through study completion, an average of 6 months
Participants satisfaction questionnaire	Measurement of participants' satisfaction with the use of the tool measured with a questionnaire designed by us.	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: University of Extremadura
• Investigators: Principal Investigator: Blanca González Sánchez, Doctor, Universidad de Extremadura

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: cerebral palsy; motor activity; motor disorders
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Motor Disorders
• Other Study ID Numbers: IPC.2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No