Efficacy of INTORUS as a Therapeutic Tool in Motor Intervention in Patients at Aspace Centres in the Province of Cáceres
Primary Purpose
Cerebral Palsy, Motor Disorders, Motor Activity
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
INTORUS
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, motor activity, motor disorders
Eligibility Criteria
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
Sites / Locations
- Blanca González SánchezRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
This group receives motor intervention sessions with the Intorus device
This group receives no motor intervention sessions with the Intorus device
Outcomes
Primary Outcome Measures
IMPROVEMENT OF UPPER LIMB MOBILITY AS MEASURED BY GONIOMETER
Measuring joint amplitude of upper limb joints with goniometer
Secondary Outcome Measures
Functional Gesture of Activities of Daily Living
Measurement of the performance of a functional gesture performed in the patient's activities of daily living.
Full Information
NCT ID
NCT05753800
First Posted
January 30, 2023
Last Updated
May 9, 2023
Sponsor
University of Extremadura
1. Study Identification
Unique Protocol Identification Number
NCT05753800
Brief Title
Efficacy of INTORUS as a Therapeutic Tool in Motor Intervention in Patients at Aspace Centres in the Province of Cáceres
Official Title
Efficacy of the INTORUS Device as a Therapeutic Tool in Motor Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Extremadura
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Motor Disorders, Motor Activity
Keywords
cerebral palsy, motor activity, motor disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
This group receives motor intervention sessions with the Intorus device
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group receives no motor intervention sessions with the Intorus device
Intervention Type
Device
Intervention Name(s)
INTORUS
Intervention Description
Motor intervention protocol with Intorus consisting of a series of exercises of progressive difficulty
Primary Outcome Measure Information:
Title
IMPROVEMENT OF UPPER LIMB MOBILITY AS MEASURED BY GONIOMETER
Description
Measuring joint amplitude of upper limb joints with goniometer
Time Frame
Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).
Secondary Outcome Measure Information:
Title
Functional Gesture of Activities of Daily Living
Description
Measurement of the performance of a functional gesture performed in the patient's activities of daily living.
Time Frame
Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).
Other Pre-specified Outcome Measures:
Title
Professional satisfaction questionnaire
Description
Measurement of professionals' satisfaction with the use of the tool measured with a questionnaire designed by ourselves.
Time Frame
Through study completion, an average of 6 months
Title
Participants satisfaction questionnaire
Description
Measurement of participants' satisfaction with the use of the tool measured with a questionnaire designed by us.
Time Frame
Through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blanca González Sánchez, Doctor
Phone
927257450
Ext
51278
Email
blgonzalezs@unex.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blanca González Sánchez, Doctor
Organizational Affiliation
Universidad de Extremadura
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blanca González Sánchez
City
Cáceres
State/Province
Caceres
ZIP/Postal Code
10001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BLANCA GONZALEZ SANCHEZ, DOCTOR
Phone
927251274
Ext
51274
Email
blgonzalezs@unex.es
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of INTORUS as a Therapeutic Tool in Motor Intervention in Patients at Aspace Centres in the Province of Cáceres
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