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

NCT05753800 | Completed

• 1 other identifier: IPC.2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Motor Disorders; Motor Activity

Keywords

cerebral palsy; motor activity; motor disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Functional Gesture of Activities of Daily Living

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

Other Outcomes (2)

• Professional satisfaction questionnaire

  Through study completion, an average of 6 months

• Participants satisfaction questionnaire

  Through study completion, an average of 6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

This group receives motor intervention sessions with the Intorus device

Device: INTORUS

Control group

NO INTERVENTION

This group receives no motor intervention sessions with the Intorus device

Interventions

INTORUS DEVICE

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

Experimental group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with another type of pathology not related to cerebral palsy.
• Under 4 years and over 18 years.

Sponsors & Collaborators

• University of Extremadura: lead

Study Sites (1)

Blanca González Sánchez

Cáceres, Caceres, 10001, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy; Motor Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavior

Study Officials

• Blanca González Sánchez, Doctor

  Universidad de Extremadura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 3, 2023
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)