Cerebral Palsy InfantileTUPEXNCT06069765
Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children
A study testing TUPEX in people with Cerebral Palsy Infantile and Chronic Pain, run by Fundacio Aspace Catalunya.
Trial summary
The goal of this clinical trial is to test the effectiveness of a trunk and upper extremities exercise program. The main questions it aims to answer are: Whether the program decreases compensation patterns in unilateral cerebral palsy children Whether the program decreases pain in unilateral cerebral palsy children… Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy Infantile, Chronic Pain, Upper Extremity Dysfunction
- What is being tested?
- TUPEX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Unilateral cerebral palsy diagnostic
- Level I or II of the Manual Ability Scale Classification
Who cannot join
- Have received any intervention with botulinum toxin or shock waves in the previous six months or have them scheduled during the intervention
- Are undergoing treatment with intensive therapies.
- To have known alteration in the hips
- Have very serious attention or comprehension difficulties that prevent them from following instructions.
- Suffer uncontrolled epilepsies
- Suffer from severe visual problems.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children: Randomized Control Trial
The goal of this clinical trial is to test the effectiveness of a trunk and upper extremities exercise program. The main questions it aims to answer are:
Whether the program decreases compensation patterns in unilateral cerebral palsy children Whether the program decreases pain in unilateral cerebral palsy children Whether the program improves bimanual ability in unilateral cerebral palsy children Participants will undertake and 8-week program exercise at home If there is a comparison group: Researchers will compare with the control group to see if this program decreases compensation patterns.
Read the detailed description
Children in control group will continue with their daily activities. Children in experimental group, apart from their daily activities, will undertake an 8-week program exercise at home for strengthening the trunk and the proximal part of both upper extremities. It contains 3 progressions that can be applied if needed.
- Being tested
- TUPEX
- Keywords
- compensation patterns, unilateral cerebral palsy
- Medical subject headings
- Cerebral Palsy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUPEXOther
This program contains exercises with their own body weight or with Thera-bands for gaining strength in their shoulder and trunk muscles. It contains some progression exercise if needed.
Each session can last between 20 and 30 minutes. Children have to do each session three times a week during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | No intervention | Children in this group will continue with their daily activities such as conventional physiotherapy and occupational therapy, even psychology, and their physical activities such as swimming or playing football. |
| TUPEX group | Experimental | Children in this group will continue with their daily activities and will add the TUPEX program during 8 weeks. Receives: Other: TUPEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of variance of the Compensation patterns
DeepLabCut (DLC) (Artificial Intelligence). Calculate the kinematic difference of the body marks during the activities
Measured: 8 weeks
Secondary outcomes (3)
Intensity of pain
Face Pain Scale - Revised (FPS-R). The face marked is compared before and after the treatment. 0 is the minimum scores, meaning no pain, and 10 is the maximum score, meaning really severe pain.
Measured: 8 weeks
Location of pain
In the Body Diagram. The location of the pain is compared before and after the treatment
Measured: 8 weeks
Bimanual ability
Children Hand-Use Experience Questionaire 2.0 (CHEQ 2.0). Whether they are more capable of doing more bimanual activities or not. The maximum score in each question is 100 and the minimum is 0. 100 means children use their hands like the neurotypical children, and 0 means they can't use the affected hand at all.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study startSep 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy InfantileStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio Aspace Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Internacional de Catalunya
- Responsible party
- Sponsor
- Investigators
- Tamara Biedermann, Study chair, Aspace Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069765
- Sponsor's protocol ID
- TrunkUpperExtremityPrograma
- Acronym
- TUPEX
- Status last verified
- Feb 2025
- First submitted
- 19 Sep 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results could be submitted for publication in Clinical Rehabilitation, Therapeutic Advances in Chronic Disease, Acta Pediatrics or in Developmental Medicine \& Child Neurology (DMCN). It is also planned to disseminate the knowledge obtained to different associations in the field of physiotherapy in pediatrics such as the Spanish Association of Intervention in the Early Childhood (AEIPI) and the Spanish Pediatric Association (AEP) or Association of Infantile Hemiparesis. Regarding the presentation at congresses, it is planned to present the results of this study at the annual congress of the European Academy of Childhood Disability, that of the Spanish Society of Child Rehabilitation or the National Congress of Rehabilitation.
Publications
Abd-Elfattah HM, Aly SM. Effect of Core Stability Exercises on Hand Functions in Children With Hemiplegic Cerebral Palsy. Ann Rehabil Med. 2021 Feb;45(1):71-78. doi: 10.5535/arm.20124. Epub 2021 Feb 9.
PubMed 33557483Mckinnon CT, Meehan EM, Harvey AR, Antolovich GC, Morgan PE. Prevalence and characteristics of pain in children and young adults with cerebral palsy: a systematic review. Dev Med Child Neurol. 2019 Mar;61(3):305-314. doi: 10.1111/dmcn.14111. Epub 2018 Dec 3.
PubMed 30508221Brochard S, Lempereur M, Mao L, Remy-Neris O. The role of the scapulo-thoracic and gleno-humeral joints in upper-limb motion in children with hemiplegic cerebral palsy. Clin Biomech (Bristol). 2012 Aug;27(7):652-60. doi: 10.1016/j.clinbiomech.2012.04.001. Epub 2012 May 2.
PubMed 22560625Francisco-Martinez C, Prado-Olivarez J, Padilla-Medina JA, Diaz-Carmona J, Perez-Pinal FJ, Barranco-Gutierrez AI, Martinez-Nolasco JJ. Upper Limb Movement Measurement Systems for Cerebral Palsy: A Systematic Literature Review. Sensors (Basel). 2021 Nov 26;21(23):7884. doi: 10.3390/s21237884.
PubMed 34883885Jackman M, Sakzewski L, Morgan C, Boyd RN, Brennan SE, Langdon K, Toovey RAM, Greaves S, Thorley M, Novak I. Interventions to improve physical function for children and young people with cerebral palsy: international clinical practice guideline. Dev Med Child Neurol. 2022 May;64(5):536-549. doi: 10.1111/dmcn.15055. Epub 2021 Sep 21.
PubMed 34549424Novak I. Evidence-based diagnosis, health care, and rehabilitation for children with cerebral palsy. J Child Neurol. 2014 Aug;29(8):1141-56. doi: 10.1177/0883073814535503. Epub 2014 Jun 22.
PubMed 24958005
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trunk and Upper Extremities Program Effect in Decreasing Compensation Patterns in Unilateral Cerebral Palsy Children: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06069765
- Acronym / sponsor ID
- TUPEX / TrunkUpperExtremityPrograma
- Keywords
- compensation patterns, unilateral cerebral palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundacio Aspace CatalunyaUniversity, hospital or other
- Collaborators
- Universitat Internacional de Catalunya
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 6 Oct 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 test the effectiveness of a trunk and upper extremities exercise program. The main questions it aims to answer are:
Whether the program decreases compensation patterns in unilateral cerebral palsy children Whether the program decreases pain in unilateral cerebral palsy children Whether the program improves bimanual ability in unilateral cerebral palsy children Participants will undertake and 8-week program exercise at home If there is a comparison group: Researchers will compare with the control group to see if this program decreases compensation patterns.
Detailed description
Children in control group will continue with their daily activities. Children in experimental group, apart from their daily activities, will undertake an 8-week program exercise at home for strengthening the trunk and the proximal part of both upper extremities. It contains 3 progressions that can be applied if needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | No intervention | –Children in this group will continue with their daily activities such as conventional physiotherapy and occupational therapy, even psychology, and their physical activities such as swimming or playing football. |
| TUPEX group | Experimental | Other: TUPEXChildren in this group will continue with their daily activities and will add the TUPEX program during 8 weeks. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Unilateral cerebral palsy diagnostic
- Level I or II of the Manual Ability Scale Classification
Key exclusion criteria (6 listed)
- Have received any intervention with botulinum toxin or shock waves in the previous six months or have them scheduled during the intervention
- Are undergoing treatment with intensive therapies.
- To have known alteration in the hips
- Have very serious attention or comprehension difficulties that prevent them from following instructions.
- Suffer uncontrolled epilepsies
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 |
|---|---|---|
| TUPEXThis program contains exercises with their own body weight or with Thera-bands for gaining strength in their shoulder and trunk muscles. It contains some progression exercise if needed. Each session can last between 20 and 30 minutes. Children have to do each session three times a week during 8 weeks. | Other | TUPEX group |
Primary outcome
Rate of variance of the Compensation patterns
Time frame: 8 weeks
DeepLabCut (DLC) (Artificial Intelligence). Calculate the kinematic difference of the body marks during the activities
3 secondary outcomes
Intensity of pain
Time frame: 8 weeks
Location of pain
Time frame: 8 weeks
Bimanual ability
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Results publication: PubMed 33557483Abd-Elfattah HM, Aly SM. Effect of Core Stability Exercises on Hand Functions in Children With Hemiplegic Cerebral Palsy. Ann Rehabil Med. 2021 Feb;45(1):71-78. doi: 10.5535/arm.20124. Epub 2021 Feb 9.
- Results publication: PubMed 30508221Mckinnon CT, Meehan EM, Harvey AR, Antolovich GC, Morgan PE. Prevalence and characteristics of pain in children and young adults with cerebral palsy: a systematic review. Dev Med Child Neurol. 2019 Mar;61(3):305-314. doi: 10.1111/dmcn.14111. Epub 2018 Dec 3.
- Results publication: PubMed 22560625Brochard S, Lempereur M, Mao L, Remy-Neris O. The role of the scapulo-thoracic and gleno-humeral joints in upper-limb motion in children with hemiplegic cerebral palsy. Clin Biomech (Bristol). 2012 Aug;27(7):652-60. doi: 10.1016/j.clinbiomech.2012.04.001. Epub 2012 May 2.
- Results publication: PubMed 34883885Francisco-Martinez C, Prado-Olivarez J, Padilla-Medina JA, Diaz-Carmona J, Perez-Pinal FJ, Barranco-Gutierrez AI, Martinez-Nolasco JJ. Upper Limb Movement Measurement Systems for Cerebral Palsy: A Systematic Literature Review. Sensors (Basel). 2021 Nov 26;21(23):7884. doi: 10.3390/s21237884.
- Results publication: PubMed 34549424Jackman M, Sakzewski L, Morgan C, Boyd RN, Brennan SE, Langdon K, Toovey RAM, Greaves S, Thorley M, Novak I. Interventions to improve physical function for children and young people with cerebral palsy: international clinical practice guideline. Dev Med Child Neurol. 2022 May;64(5):536-549. doi: 10.1111/dmcn.15055. Epub 2021 Sep 21.
- Results publication: PubMed 24958005Novak I. Evidence-based diagnosis, health care, and rehabilitation for children with cerebral palsy. J Child Neurol. 2014 Aug;29(8):1141-56. doi: 10.1177/0883073814535503. Epub 2014 Jun 22.
- Individual participant dataSharing planned: Yes. The results could be submitted for publication in Clinical Rehabilitation, Therapeutic Advances in Chronic Disease, Acta Pediatrics or in Developmental Medicine \& Child Neurology (DMCN). It is also planned to disseminate the knowledge obtained to different associations in the field of physiotherapy in pediatrics such as the Spanish Association of Intervention in the Early Childhood (AEIPI) and the Spanish Pediatric Association (AEP) or Association of Infantile Hemiparesis. Regarding the presentation at congresses, it is planned to present the results of this study at the annual congress of the European Academy of Childhood Disability, that of the Spanish Society of Child Rehabilitation or the National Congress of Rehabilitation.
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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.
Tamara Biedermann study chair
Aspace Catalunya
Questions about this trial
What is this clinical trial studying?
A study testing TUPEX in people with Cerebral Palsy Infantile and Chronic Pain, run by Fundacio Aspace Catalunya.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgina Domenech Garcia (+34 656707865, gdomenech@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of variance of the Compensation patterns (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06069765, which also lists 6 linked publications.
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 14 Feb 2025.