Efficacy of INTORUS as a Therapeutic Tool in Motor Intervention in Patients at Aspace Centres in the Province of Cáceres
NCT ID: NCT05753800
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2023-01-01
2023-08-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental group
This group receives motor intervention sessions with the Intorus device
INTORUS
Motor intervention protocol with Intorus consisting of a series of exercises of progressive difficulty
Control group
This group receives no motor intervention sessions with the Intorus device
No interventions assigned to this group
Interventions
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INTORUS
Motor intervention protocol with Intorus consisting of a series of exercises of progressive difficulty
Eligibility Criteria
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Inclusion Criteria
* Ages between 4 and 18 years.
* Motor disability.
* Affectation in the mobility of upper limbs.
* Informed consent signed by parents/guardians.
Exclusion Criteria
* Under 4 years and over 18 years.
4 Years
18 Years
ALL
No
Sponsors
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University of Extremadura
OTHER
Responsible Party
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Blanca González Sanchez
doctor
Principal Investigators
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Blanca González Sánchez, Doctor
Role: PRINCIPAL_INVESTIGATOR
Universidad de Extremadura
Locations
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Blanca González Sánchez
Cáceres, Caceres, Spain
Countries
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Other Identifiers
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IPC.2023
Identifier Type: -
Identifier Source: org_study_id