Cerebral PalsyNCT05753800
Efficacy of INTORUS as a Therapeutic Tool in Motor Intervention in Patients at Aspace Centres in the Province of Cáceres
A study testing INTORUS in people with Cerebral Palsy and Motor Disorders, run by University of Extremadura at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Motor Disorders, Motor Activity
- What is being tested?
- INTORUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy, Motor Disorders, Motor Activity
- Being tested
- INTORUS
- Keywords
- cerebral palsy, motor activity, motor disorders
- Medical subject headings
- Cerebral Palsy, Motor Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTORUSDevice
Motor intervention protocol with Intorus consisting of a series of exercises of progressive difficulty
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | This group receives motor intervention sessions with the Intorus device Receives: Device: INTORUS |
| Control group | No intervention | This group receives no motor intervention sessions with the Intorus device |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMPROVEMENT OF UPPER LIMB MOBILITY AS MEASURED BY GONIOMETER
Measuring joint amplitude of upper limb joints with goniometer
Measured: 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
Measurement of the performance of a functional gesture performed in the patient's activities of daily living.
Measured: Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca González Sanchez, University of Extremadura
- Investigators
- Blanca González Sánchez, Doctor, Principal investigator, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753800
- Sponsor's protocol ID
- IPC.2023
- Status last verified
- Nov 2023
- First submitted
- 30 Jan 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the INTORUS Device as a Therapeutic Tool in Motor Intervention
- ClinicalTrials.gov ID
- NCT05753800
- Acronym / sponsor ID
- IPC.2023
- Conditions
- Cerebral Palsy, Motor Disorders, Motor Activity
- Keywords
- cerebral palsy, motor activity, motor disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: INTORUSThis group receives motor intervention sessions with the Intorus device |
| Control group | No intervention | –This group receives no motor intervention sessions with the Intorus device |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTORUSMotor intervention protocol with Intorus consisting of a series of exercises of progressive difficulty | Device | Experimental group |
Primary outcome
IMPROVEMENT OF UPPER LIMB MOBILITY AS MEASURED BY GONIOMETER
Time frame: 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
1 secondary outcome
Functional Gesture of Activities of Daily Living
Time frame: Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blanca González Sánchez, Doctor principal investigator
Universidad de Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTORUS in people with Cerebral Palsy and Motor Disorders, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMPROVEMENT OF UPPER LIMB MOBILITY AS MEASURED BY GONIOMETER (time frame: Before starting treatment. After 20 weeks of treatment and at the end of treatment (40 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.