Cerebral PalsyPalsy202503NCT06909994
Daily Living Activities in Young Adults With Cerebral Palsy
An observational study of Cerebral Palsy and Sensitivity, run by Universidad de Burgos at 1 site in Spain.
Trial summary
This study explored the relationship between sensory function and occupational performance in young adults with Cerebral Palsy. Using standardized assessments, researchers compared tactile sensitivity and discrimination between individuals with CP and neurotypical controls, and examined how these sensory variables… Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Cerebral Palsy, Sensitivity, Motor Skills Disorders
- What is being tested?
- individual assessments
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 7 Mar 2025to 26 Mar 2025
- Phase
- Observational
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A multicenter cross-sectional study was conducted involving two groups of 36 participants aged 16-45 years.
Who may be able to join
- young people and adults with a medical diagnosis of CP, who had a motor condition of hemiparesis, diparesis, or tetraparesis;
- aged between 16 and 45 years
- had a minimum score of 19 on the Mini Mental State Examination cognitive assessment scale
- authorized their participation in the study by signing an informed consent form. In cases between the ages of 16 and 18 years, informed consent was signed by the participants and their parents or legal guardians
Who cannot join
- any peripheral nerve injury
- shoulder, elbow, wrist or hand injuries
- individuals whose mother tongue was neither Portuguese nor Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensory Function and Its Relationship With Motor Performance and Daily Living Activities in Young Adults With Cerebral Palsy
This study explored the relationship between sensory function and occupational performance in young adults with Cerebral Palsy. Using standardized assessments, researchers compared tactile sensitivity and discrimination between individuals with CP and neurotypical controls, and examined how these sensory variables relate to motor function, ADLs, and IADLs.
Read the detailed description
Background: Sensory impairments are increasingly recognized as influential factors in the occupational performance of individuals with Cerebral Palsy (CP). Although prior studies have explored this relationship in children, evidence in young adults remains limited.
Objective: This study aimed to compare tactile sensitivity and discrimination in young adults with CP and neurotypical individuals, and to examine their association with motor-related variables relevant to occupational performance: muscle tone, grip strength, manual dexterity, Activities of Daily Living (ADLs), and Instrumental Activities of Daily Living (IADLs).
Methods: A multicenter cross-sectional study was conducted involving two groups of 36 participants aged 16-45 years. Sensory and motor variables were assessed using the Semmes-Weinstein Monofilaments, Two-Point Discrimination Test, Modified Ashworth Scale, Digital Dynamometer, Box and Block Test, Functional Independence Measure, and the Lawton and Brody Scale.
Conclusion: Findings highlight the relevance of sensory function in the occupational performance of young adults with CP. These results underscore the need for occupational therapy interventions that integrate sensory assessments and target sensory-motor integration to improve functional independence and participation.
- Conditions
- Cerebral Palsy, Sensitivity, Motor Skills Disorders, Activity, Motor
- Being tested
- individual assessments
- Medical subject headings
- Cerebral Palsy, Hypersensitivity, Motor Skills Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual assessmentsOther
Participants in the CP group underwent individual assessments using seven standardized instruments to evaluate sensory and motor function, as well as independence in daily activities. Data collection was conducted in person at the participating institutions by trained professionals following a structured protocol. All procedures were performed after verifying cognitive eligibility (score ≥ 19) and obtaining informed consent. The same protocol was applied across both centers to ensure consistency. The control group followed the same assessment process. Each evaluation session lasted approximately two hours per participant.
| Study group | Role | What they receive |
|---|---|---|
| Young Adults | A multicenter cross-sectional study was conducted involving two groups of 36 participants aged 16-45 years. Sensory and motor variables were assessed using the Semmes-Weinstein Monofilaments, Two-Point Discrimination Test, Modified Ashworth Scale, Digital Dynamometer, Box and Block Test, Functional Independence Measure, and the Lawton and Brody Scale. | |
| Cerebral Palsy | A multicenter cross-sectional study was conducted involving two groups of 36 participants aged 16-45 years. Sensory and motor variables were assessed using the Semmes-Weinstein Monofilaments, Two-Point Discrimination Test, Modified Ashworth Scale, Digital Dynamometer, Box and Block Test, Functional Independence Measure, and the Lawton and Brody Scale. Receives: Other: individual assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semmes-Weinstein monofilaments
This non-invasive technique assesses cutaneous sensory perception using nylon monofilaments of varying diameters that apply specific pressure forces. These forces range from 0.07 g (smallest) to 300 g (largest). In this study, monofilaments were applied to distinct areas innervated by different nerves: the distal phalanx of the first, second, and third fingers and the thenar eminence (median nerve), the fifth finger and hypothenar eminence (ulnar nerve), and the proximal phalanx of the first and second fingers on the dorsal side (radial nerve).
Measured: 1 month
Two-point discrimination test
This test evaluates the ability to distinguish between two closely spaced pressure points on the skin, reflecting sensory acuity and receptor density. Distances typically range from 0 to 8 mm. Despite being widely used, standardization of pressure remains a challenge; a light, uniform pressure (10-15 g) is recommended. In this study, the same hand regions assessed with monofilaments were used. Proper simultaneous application was ensured to avoid perception bias.
Measured: 1 month
Modified Ashworth Scale (MAS)
The MAS is widely used to evaluate muscle spasticity by measuring resistance to passive movement. The scale ranges from 0 (no tone increase) to 4 (severe rigidity), with the inclusion of score 1+ for greater sensitivity. In this study, assessments were performed on elbow and wrist flexor/extensor muscles, muscles involved in pronation/supination, and finger flexors/extensors. The scale helps quantify the degree of hypertonia, a common symptom in individuals with neurological conditions.
Measured: 1 month
Digital dynamometer
Grip strength was measured using a handheld digital dynamometer, which quantifies isometric force output in kilograms. Testing was conducted with participants seated, shoulder adducted, elbow at 90º, forearm in neutral, and wrist extended 0º-30º. Both upper limbs were assessed. This measurement reflects overall upper limb strength and functional capacity, and is considered a reliable indicator of motor performance in clinical populations.
Measured: 1 month
Box and Block Test
This test evaluates unilateral manual dexterity by counting the number of wooden blocks a participant can transfer from one side of a partitioned box to the other within 60 seconds. A 15-second practice trial was included to ensure familiarity with the procedure. It is a validated tool for individuals with neurological impairments and provides a quick, functional measure of hand coordination. Performance was assessed for both dominant and non-dominant hands.
Measured: 1 month
Functional Independence Measure
The FIM assesses performance in Activities of Daily Living (ADLs) across two domains: motor (13 items) and cognitive/social (5 items). Each item is rated on a 7-point scale from total dependence (1) to complete independence (7), with a maximum total score of 126. It evaluates self-care, sphincter control, mobility, communication, and social cognition. This tool is widely used to determine the level of assistance required in daily life
Measured: 1 month
Lawton and Brody Scale
This scale measures independence in Instrumental Activities of Daily Living (IADLs), such as using the telephone, managing medications and finances, shopping, cooking, and transportation. Scores range from 0 (dependent in all tasks) to 8 (independent in all tasks). It is particularly useful for evaluating more complex, community-based activities that are essential for independent living and is a standard tool in occupational therapy and geriatric assessment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start7 Mar 2025
- Primary completion20 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909994
- Sponsor's protocol ID
- Palsy202503
- Other IDs
- UBurgos
- Acronym
- Palsy202503
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no data sharing plan for individual participant data (IPD) associated with this study. No IPD will be shared with other researchers.
Publications
Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.
PubMed 32606703Paul S, Nahar A, Bhagawati M, Kunwar AJ. A Review on Recent Advances of Cerebral Palsy. Oxid Med Cell Longev. 2022 Jul 30;2022:2622310. doi: 10.1155/2022/2622310. eCollection 2022.
PubMed 35941906Bleyenheuft Y, Gordon AM. Precision grip control, sensory impairments and their interactions in children with hemiplegic cerebral palsy: a systematic review. Res Dev Disabil. 2013 Sep;34(9):3014-28. doi: 10.1016/j.ridd.2013.05.047. Epub 2013 Jun 29.
PubMed 23816634
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Function and Its Relationship With Motor Performance and Daily Living Activities in Young Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06909994
- Acronym / sponsor ID
- Palsy202503 / Palsy202503
- Conditions
- Cerebral Palsy, Sensitivity, Motor Skills Disorders, Activity, Motor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Study start
- 7 Mar 2025 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 4 Apr 2025 (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 explored the relationship between sensory function and occupational performance in young adults with Cerebral Palsy. Using standardized assessments, researchers compared tactile sensitivity and discrimination between individuals with CP and neurotypical controls, and examined how these sensory variables relate to motor function, ADLs, and IADLs.
Detailed description
Background: Sensory impairments are increasingly recognized as influential factors in the occupational performance of individuals with Cerebral Palsy (CP). Although prior studies have explored this relationship in children, evidence in young adults remains limited.
Objective: This study aimed to compare tactile sensitivity and discrimination in young adults with CP and neurotypical individuals, and to examine their association with motor-related variables relevant to occupational performance: muscle tone, grip strength, manual dexterity, Activities of Daily Living (ADLs), and Instrumental Activities of Daily Living (IADLs).
Methods: A multicenter cross-sectional study was conducted involving two groups of 36 participants aged 16-45 years. Sensory and motor variables were assessed using the Semmes-Weinstein Monofilaments, Two-Point Discrimination Test, Modified Ashworth Scale, Digital Dynamometer, Box and Block Test, Functional Independence Measure, and the Lawton and Brody Scale.
Conclusion: Findings highlight the relevance of sensory function in the occupational performance of young adults with CP. These results underscore the need for occupational therapy interventions that integrate sensory assessments and target sensory-motor integration to improve functional independence and participation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Adults | – | –A multicenter cross-sectional study was conducted involving two groups of 36 participants aged 16-45 years. Sensory and motor variables were assessed using the Semmes-Weinstein Monofilaments, Two-Point Discrimination Test, Modified Ashworth Scale, Digital Dynamometer, Box and Block Test, Functional Independence Measure, and the Lawton and Brody Scale. |
| Cerebral Palsy | – | Other: individual assessmentsA multicenter cross-sectional study was conducted involving two groups of 36 participants aged 16-45 years. Sensory and motor variables were assessed using the Semmes-Weinstein Monofilaments, Two-Point Discrimination Test, Modified Ashworth Scale, Digital Dynamometer, Box and Block Test, Functional Independence Measure, and the Lawton and Brody Scale. |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A multicenter cross-sectional study was conducted involving two groups of 36 participants aged 16-45 years.
Key inclusion criteria (4 listed)
- young people and adults with a medical diagnosis of CP, who had a motor condition of hemiparesis, diparesis, or tetraparesis;
- aged between 16 and 45 years
- had a minimum score of 19 on the Mini Mental State Examination cognitive assessment scale
- authorized their participation in the study by signing an informed consent form. In cases between the ages of 16 and 18 years, informed consent was signed by the participants and their parents or legal guardians
Key exclusion criteria (3 listed)
- any peripheral nerve injury
- shoulder, elbow, wrist or hand injuries
- individuals whose mother tongue was neither Portuguese nor Spanish
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 |
|---|---|---|
| individual assessmentsParticipants in the CP group underwent individual assessments using seven standardized instruments to evaluate sensory and motor function, as well as independence in daily activities. Data collection was conducted in person at the participating institutions by trained professionals following a structured protocol. All procedures were performed after verifying cognitive eligibility (score ≥ 19) and obtaining informed consent. The same protocol was applied across both centers to ensure consistency. The control group followed the same assessment process. Each evaluation session lasted approximately two hours per participant. | Other | Cerebral Palsy |
Primary outcome
Semmes-Weinstein monofilaments
Time frame: 1 month
This non-invasive technique assesses cutaneous sensory perception using nylon monofilaments of varying diameters that apply specific pressure forces. These forces range from 0.07 g (smallest) to 300 g (largest). In this study, monofilaments were applied to distinct areas innervated by different nerves: the distal phalanx of the first, second, and third fingers and the thenar eminence (median nerve), the fifth finger and hypothenar eminence (ulnar nerve), and the proximal phalanx of the first and second fingers on the dorsal side (radial nerve).
Two-point discrimination test
Time frame: 1 month
This test evaluates the ability to distinguish between two closely spaced pressure points on the skin, reflecting sensory acuity and receptor density. Distances typically range from 0 to 8 mm. Despite being widely used, standardization of pressure remains a challenge; a light, uniform pressure (10-15 g) is recommended. In this study, the same hand regions assessed with monofilaments were used. Proper simultaneous application was ensured to avoid perception bias.
Modified Ashworth Scale (MAS)
Time frame: 1 month
The MAS is widely used to evaluate muscle spasticity by measuring resistance to passive movement. The scale ranges from 0 (no tone increase) to 4 (severe rigidity), with the inclusion of score 1+ for greater sensitivity. In this study, assessments were performed on elbow and wrist flexor/extensor muscles, muscles involved in pronation/supination, and finger flexors/extensors. The scale helps quantify the degree of hypertonia, a common symptom in individuals with neurological conditions.
Digital dynamometer
Time frame: 1 month
Grip strength was measured using a handheld digital dynamometer, which quantifies isometric force output in kilograms. Testing was conducted with participants seated, shoulder adducted, elbow at 90º, forearm in neutral, and wrist extended 0º-30º. Both upper limbs were assessed. This measurement reflects overall upper limb strength and functional capacity, and is considered a reliable indicator of motor performance in clinical populations.
Box and Block Test
Time frame: 1 month
This test evaluates unilateral manual dexterity by counting the number of wooden blocks a participant can transfer from one side of a partitioned box to the other within 60 seconds. A 15-second practice trial was included to ensure familiarity with the procedure. It is a validated tool for individuals with neurological impairments and provides a quick, functional measure of hand coordination. Performance was assessed for both dominant and non-dominant hands.
Functional Independence Measure
Time frame: 1 month
The FIM assesses performance in Activities of Daily Living (ADLs) across two domains: motor (13 items) and cognitive/social (5 items). Each item is rated on a 7-point scale from total dependence (1) to complete independence (7), with a maximum total score of 126. It evaluates self-care, sphincter control, mobility, communication, and social cognition. This tool is widely used to determine the level of assistance required in daily life
Lawton and Brody Scale
Time frame: 1 month
This scale measures independence in Instrumental Activities of Daily Living (IADLs), such as using the telephone, managing medications and finances, shopping, cooking, and transportation. Scores range from 0 (dependent in all tasks) to 8 (independent in all tasks). It is particularly useful for evaluating more complex, community-based activities that are essential for independent living and is a standard tool in occupational therapy and geriatric assessment
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 4 Apr 2025.
- Background: PubMed 32606703Sadowska M, Sarecka-Hujar B, Kopyta I. Cerebral Palsy: Current Opinions on Definition, Epidemiology, Risk Factors, Classification and Treatment Options. Neuropsychiatr Dis Treat. 2020 Jun 12;16:1505-1518. doi: 10.2147/NDT.S235165. eCollection 2020.
- Background: PubMed 35941906Paul S, Nahar A, Bhagawati M, Kunwar AJ. A Review on Recent Advances of Cerebral Palsy. Oxid Med Cell Longev. 2022 Jul 30;2022:2622310. doi: 10.1155/2022/2622310. eCollection 2022.
- Background: PubMed 23816634Bleyenheuft Y, Gordon AM. Precision grip control, sensory impairments and their interactions in children with hemiplegic cerebral palsy: a systematic review. Res Dev Disabil. 2013 Sep;34(9):3014-28. doi: 10.1016/j.ridd.2013.05.047. Epub 2013 Jun 29.
- Individual participant dataSharing planned: No. There is no data sharing plan for individual participant data (IPD) associated with this study. No IPD will be shared with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Sensitivity, run by Universidad de Burgos 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 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 4 Apr 2025. 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?
Semmes-Weinstein monofilaments (time frame: 1 month). The study lists 7 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 NCT06909994, which also lists 3 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 4 Apr 2025.