Unilateral Cerebral PalsyNCT04235088
Impact of Somatosensory Intensive Intervention on Motor Performance in Children With Unilateral Cerebral Palsy
A study testing Somatosensory intensive intervention in people with Unilateral Cerebral Palsy, run by Universidad San Jorge at 1 site in Spain.
Trial summary
This study aims to investigate the effectiveness of an intensive somatosensory intervention in the upper limb of children with hemiparesis regarding structure, function, activity and participation Hypothesis: Intensive somatosensory activity based intervention is effective in upper limb and hand ability in children… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Unilateral Cerebral Palsy
- What is being tested?
- Somatosensory intensive intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 5 Sep 2020to 12 Mar 2021
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of unilateral cerebral palsy
- Manual Ability Classification System (MACS): levels I, II y III.
- Gender: male and female
- Age: 6 to 15 years old
Who cannot join
- Existence of a moderate or severe cognitive impairment, which could interfere with the comprehension of the tester cues
- Botulinum toxic infiltration 4 months before the date of the pre-intervention assessment or during intervention or during the 3 months after the final intervention
- To have suffered any injury such as fractures and/or contusions in the upper limb in the last 12 months
- Orthopedic intervention in the 6 months preceding the study or during the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Asociación para la Investigación en la Discapacidad Motriz (AIDIMO)
Zaragoza, Zaragoza, 50011
About this study
Official title: Impact of Somatosensory Intensive Intervention on Motor Performance of the Upper Limb and Participation in Children With Unilateral Cerebral Palsy: a Feasibility Study
This study aims to investigate the effectiveness of an intensive somatosensory intervention in the upper limb of children with hemiparesis regarding structure, function, activity and participation
Hypothesis:
Intensive somatosensory activity based intervention is effective in upper limb and hand ability in children with hemiparesis, specially regarding activity and participation
Read the detailed description
Feasibility and longitudinal study with blinding of the evaluator and the person analyzing the data. The study have 3 procedures:
- - Assessment pre-intervention
- - Intervention: three weeks
- - Assessment post-intervention
- Conditions
- Unilateral Cerebral Palsy
- Being tested
- Somatosensory intensive intervention
- Keywords
- somatosensory intensive intervention, somatosensory processing, motor performance, participation, quality of live, occupational performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatosensory intensive interventionOther
The intensive somato-sensory intervention will take place during 3 weeks, 5 days per week, for 2 hours per day (30 hours of practice). During the week-ends, some somato-sensory written activities will be explained and handed to each family (6 hours of practice) Therapy sessions will be carried out in groups and each child will have his or her own therapist in charge of his or her treatment along the whole intervention. A daily check-list, design for that purpose, will be used by the therapist in order to register the gradually increased complexity of the activities and individual progression. The principal investigator will supervise all the interventions in order to assure their uniformity, adjusting the somato-sensory training protocol to the individual needs of each subject.
| Study group | Role | What they receive |
|---|---|---|
| Somatosensory intensive intervention | Experimental | Not described Receives: Other: Somatosensory intensive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Canadian Occupational Performance Measure (COPM).
Participation measure (family aims). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.
Measured: baseline, immediately after intervention
Change in Children´s hand-use Experience Questionnaire (CHEQ).
Activity Measure (bimanual performance). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.
Measured: baseline, immediately after intervention
Secondary outcomes (8)
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).
Activity measure (daily activities, mobility, social/cognitive and responsibility).
Measured: baseline, immediately after intervention
Change in Jebsen Taylor Hand Function Test.
Activity Measure (unimanual capacity).
Measured: baseline, immediately after intervention
Change in Box and Blocks Test.
Activity measure (unilateral gross manual dexterity).
Measured: baseline, immediately after intervention
Change in Sensory Profile™ 2 family Questionnaire (Winnie Dunn)
Evaluate a child's sensory processing patterns in the context of home, school, and community-based activities.
Measured: baseline, immediately after intervention
Change in Kidscreen Questionnaire.
Participation measure (Quality of live).
Measured: baseline, immediately after intervention
Change in Somatosensory Battery Assessment.
Body structures and functions measure. Includes: registration (Semmes Weinstein monofilaments); Two points discrimination (Aesthesiometer); Single Point Location; double simultaneous, forms stereognosis (Manual Form Perception Test_ SIPT), stereognosis of familiar objects, graphesthesia (SIPT), clinical observation of texture perception, clinical observation of proprioception, pain (algometer) and functional sensitivity (Box and Blocks without vision).
Measured: baseline, immediately after intervention
Change in Dynamometer (grip strength)
Body structures and functions measure (grip strength).
Measured: baseline, immediately after intervention
Change in Pinch Gauge (pinch strength).
Body structures and functions measure (pinch strength).
Measured: baseline, immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start5 Sep 2020
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unilateral 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- César Cuesta García, Study director, Occupational Thinks Research Group, Autónoma University (Madrid)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235088
- Sponsor's protocol ID
- UCP Somatosensory intervention
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2020
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jovellar-Isiegas P, Roche-Seruendo LE, Jaen-Carrillo D, Gomez-Barrera M, Cuesta-Garcia C. An exploratory pre-post study of an intensive somatosensory activity-based intervention on participation-related goals, motor performance and somatosensory function in children with unilateral cerebral palsy. Front Pediatr. 2026 Jun 25;14:1862592. doi: 10.3389/fped.2026.1862592. eCollection 2026.
PubMed 42427947
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Somatosensory Intensive Intervention on Motor Performance of the Upper Limb and Participation in Children With Unilateral Cerebral Palsy: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04235088
- Acronym / sponsor ID
- UCP Somatosensory intervention
- Conditions
- Unilateral Cerebral Palsy
- Keywords
- somatosensory intensive intervention, somatosensory processing, motor performance, participation, quality of live, occupational performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- 5 Sep 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 21 Jan 2020 (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.
This study aims to investigate the effectiveness of an intensive somatosensory intervention in the upper limb of children with hemiparesis regarding structure, function, activity and participation
Hypothesis:
Intensive somatosensory activity based intervention is effective in upper limb and hand ability in children with hemiparesis, specially regarding activity and participation
Detailed description
Feasibility and longitudinal study with blinding of the evaluator and the person analyzing the data. The study have 3 procedures:
- - Assessment pre-intervention
- - Intervention: three weeks
- - Assessment post-intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Somatosensory intensive intervention | Experimental | Other: Somatosensory intensive intervention |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of unilateral cerebral palsy
- Manual Ability Classification System (MACS): levels I, II y III.
- Gender: male and female
- Age: 6 to 15 years old
Key exclusion criteria (4 listed)
- Existence of a moderate or severe cognitive impairment, which could interfere with the comprehension of the tester cues
- Botulinum toxic infiltration 4 months before the date of the pre-intervention assessment or during intervention or during the 3 months after the final intervention
- To have suffered any injury such as fractures and/or contusions in the upper limb in the last 12 months
- Orthopedic intervention in the 6 months preceding the study or during the study
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 |
|---|---|---|
| Somatosensory intensive interventionThe intensive somato-sensory intervention will take place during 3 weeks, 5 days per week, for 2 hours per day (30 hours of practice). During the week-ends, some somato-sensory written activities will be explained and handed to each family (6 hours of practice) Therapy sessions will be carried out in groups and each child will have his or her own therapist in charge of his or her treatment along the whole intervention. A daily check-list, design for that purpose, will be used by the therapist in order to register the gradually increased complexity of the activities and individual progression. The principal investigator will supervise all the interventions in order to assure their uniformity, adjusting the somato-sensory training protocol to the individual needs of each subject. | Other | Somatosensory intensive intervention |
Primary outcome
Change in Canadian Occupational Performance Measure (COPM).
Time frame: baseline, immediately after intervention
Participation measure (family aims). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.
Change in Children´s hand-use Experience Questionnaire (CHEQ).
Time frame: baseline, immediately after intervention
Activity Measure (bimanual performance). Primary outcomes will be reported in separate manuscripts due to scope/space considerations.
8 secondary outcomes
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT).
Time frame: baseline, immediately after intervention
Change in Jebsen Taylor Hand Function Test.
Time frame: baseline, immediately after intervention
Change in Box and Blocks Test.
Time frame: baseline, immediately after intervention
Change in Sensory Profile™ 2 family Questionnaire (Winnie Dunn)
Time frame: baseline, immediately after intervention
Change in Kidscreen Questionnaire.
Time frame: baseline, immediately after intervention
Change in Somatosensory Battery Assessment.
Time frame: baseline, immediately after intervention
Change in Dynamometer (grip strength)
Time frame: baseline, immediately after intervention
Change in Pinch Gauge (pinch strength).
Time frame: baseline, immediately after intervention
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 16 Apr 2026.
- Derived from this study: PubMed 42427947Jovellar-Isiegas P, Roche-Seruendo LE, Jaen-Carrillo D, Gomez-Barrera M, Cuesta-Garcia C. An exploratory pre-post study of an intensive somatosensory activity-based intervention on participation-related goals, motor performance and somatosensory function in children with unilateral cerebral palsy. Front Pediatr. 2026 Jun 25;14:1862592. doi: 10.3389/fped.2026.1862592. eCollection 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
César Cuesta García study director
Occupational Thinks Research Group, Autónoma University (Madrid)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatosensory intensive intervention in people with Unilateral Cerebral Palsy, run by Universidad San Jorge 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 4 inclusion and 4 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 16 Apr 2026. 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?
Change in Canadian Occupational Performance Measure (COPM). (time frame: baseline, immediately after intervention). The study lists 2 primary outcomes in all. 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 NCT04235088, which also lists 1 linked publication.
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 16 Apr 2026.