NCT06909994

Brief 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 relate to motor function, ADLs, and IADLs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2025

Completed
Last Updated

April 4, 2025

Status Verified

March 1, 2025

Enrollment Period

13 days

First QC Date

March 26, 2025

Last Update Submit

April 2, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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).

    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.

    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.

    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.

    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.

    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

    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

    1 month

Study Arms (2)

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.

Other: individual assessments

Interventions

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.

Cerebral Palsy

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

A multicenter cross-sectional study was conducted involving two groups of 36 participants aged 16-45 years.

You may qualify if:

  • 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

You may not qualify if:

  • any peripheral nerve injury
  • shoulder, elbow, wrist or hand injuries
  • individuals whose mother tongue was neither Portuguese nor Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olalla Saiz Vazquez

Burgos, Burgos, 09003, Spain

Location

Related Publications (3)

  • Kangas T. [Foot problems in diabetes]. Duodecim. 1981;97(12):872-8. No abstract available. Finnish.

    PMID: 7297454BACKGROUND
  • Mesquita MA, Balbino EP, Albuquerque RS, Carmona CA, Okubo BT, Lorena SL, Montes CG, Soares EC. Ceftriaxone in the treatment of spontaneous bacterial peritonitis: ascitic fluid polymorphonuclear count response and short-term prognosis. Hepatogastroenterology. 1997 Sep-Oct;44(17):1276-80.

    PMID: 9356840BACKGROUND
  • Bleyenheuft 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.

    PMID: 23816634BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyHypersensitivityMotor Skills DisordersMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesImmune System DiseasesNeurodevelopmental DisordersMental DisordersBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2025

First Posted

April 4, 2025

Study Start

March 7, 2025

Primary Completion

March 20, 2025

Study Completion

March 26, 2025

Last Updated

April 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

There is no data sharing plan for individual participant data (IPD) associated with this study. No IPD will be shared with other researchers.

Locations