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

Not Applicable

Completed

• Conditions: Motor Disorders; Motor Activity; Cerebral Palsy
• Interventions: Device: INTORUS

• Registration Number: NCT05753800
• Lead Sponsor: University of Extremadura

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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-03-03
• Primary Completion: 2023-06-30
• Study Completion: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	INTORUS	This group receives motor intervention sessions with the Intorus device

Primary Outcome Measures

Name	Time	Method
IMPROVEMENT OF UPPER LIMB MOBILITY AS MEASURED BY GONIOMETER	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 Outcome Measures

Name	Time	Method
Functional Gesture of Activities of Daily Living	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.

Trial Locations

Locations (1)

Blanca González Sánchez; 🇪🇸 Cáceres, Caceres, Spain