- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06949449
Upper Limb Function in Mental Health Disorders (UFMC-MH2025)
Upper Limb Functional Capacity in Individuals Diagnosed With Mental Disorders: A Cross-Sectional Study
Background: Individuals with mental disorders (MD) often experience motor issues, yet upper limb functionality remains understudied.
Objective: To compare upper limb function in individuals with and without MD, focusing on motor capacity, dexterity, and performance.
Design: Cross-sectional, qualitative, multicenter study. Methods: Assessed strength, motor skills, sensitivity, and daily function. Used T-test, Mann-Whitney U, Spearman correlation, and Chi-square.
Study Overview
Status
Conditions
Detailed Description
Background: Research suggests individuals with mental disorders (MD) often face motor difficulties, such as issues with gait and posture. However, there is limited research on upper limb functionality in the mental health context.
Objective: To compare upper limb functionality between individuals with and without MD, focusing on differences in motor capacity, manual dexterity, and functional performance.
Study Design: Cross-sectional, qualitative, multicenter study.
Methods: Strength, fine and gross motor skills, sensitivity, tactile discrimination, and were assessed, along with functional limitations in daily activities. Statistical methods used included independent samples T-test, Mann-Whitney U test, Spearman correlation, and Chi-square test.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Burgos, Spain, 09001
- University of Burgos
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
A convenience sample of 38 participants was obtained, consisting of 19 individuals diagnosed with a mental disorder (MD) and 19 healthy controls.
Initially, 40 participants were contacted; however, two were unable to participate due to scheduling conflicts that prevented them from completing the assessment.
Description
Inclusion Criteria:
Mental Disorder Group
- Participants with a mental disorder (MD) had to meet the following criteria:
- A formal diagnosis of a mental disorder according to the DSM-V.
- Aged between 18 and 65 years.
- Treatment stability, defined as being under stable pharmacological and psychiatric treatment for at least three months.
- Clinical stability, meaning no acute psychiatric episodes in the last three months that could interfere with participation in the study.
- Ability to follow instructions and communicate effectively, confirmed by scoring at least 23 points on the Mini-Mental State Examination (MMSE).
Control Group (Healthy Participants)
- Healthy individuals were required to meet the following inclusion criteria:
- Aged between 18 and 65 years.
- Ability to follow instructions and communicate effectively, also defined by a minimum MMSE score of 23.
Exclusion Criteria:
- Presence of neurological conditions, such as multiple sclerosis, stroke, or similar disorders.
- History of upper limb rehabilitation within the past six months.
- Any acute or chronic condition affecting the upper limb that could interfere with the results, including but not limited to arthritis, osteoarthritis, or carpal tunnel syndrome.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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EXPERIMENTAL GROUP
Participants diagnosed with a mental disorder (MD).
Evaluated for upper limb functionality, including strength, fine and gross manual dexterity, sensitivity, tactile discrimination, and performance in activities of daily living (ADL).
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CONTROL GROUP
Participants without any diagnosed mental disorder.
Assessed using the same measures to serve as a baseline for comparison with the MD group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Nine Hole Peg Test (NHPT)
Time Frame: 3 weeks
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Assesses fine manual dexterity. Participants place and remove nine pegs from holes as quickly as possible, using one hand at a time. The test is performed twice, and the average time is recorded. Lower scores indicate better fine motor skills. The NHPT has shown high test-retest reliability, inter-rater reliability, and internal consistency in previous studies, including Spanish-speaking populations. |
3 weeks
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Box and Block Test (BBT)
Time Frame: 3 weeks
|
Measures gross manual dexterity. Participants move as many blocks as possible from one compartment of a box to another in one minute, using each hand separately. Blocks must be moved over a dividing wall without throwing or bumping. Higher scores indicate better gross dexterity. The BBT is widely used and validated across different populations. |
3 weeks
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Digital Hand Dynamometer
Time Frame: 3 weeks
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Evaluates grip strength. Participants squeeze a hydraulic hand dynamometer three times with each hand while seated with the elbow at 90°. The average of the three trials is used. Higher scores indicate greater grip strength. This test has strong validity, sensitivity, and reliability, including among Spanish-speaking populations. |
3 weeks
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Semmes-Weinstein Monofilament Test
Time Frame: 3 weeks
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Assesses tactile sensitivity. Monofilaments of varying thickness are applied to specific areas of the hand (fingertips, palm, back of the hand). The finest filament perceived consistently (at least 2 out of 3 times) is recorded as the sensitivity threshold. There is limited psychometric data available in Spanish-speaking populations, though the test is widely used clinically. |
3 weeks
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Two-Point Discrimination Test (Touch-Test)
Time Frame: 3 weeks
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Evaluates tactile discrimination ability. Two points are applied to the skin at decreasing distances until the participant can no longer distinguish them as separate. Tested on the same hand areas as the monofilament test. It assesses the density of tactile receptors and sensory pathway integrity. Psychometric properties in Spanish-speaking populations are not well established. |
3 weeks
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QuickDASH Questionnaire
Time Frame: 3 weeks
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A shortened version of the DASH questionnaire, designed to evaluate disability and symptoms in the upper limb. It consists of 11 items rated on a 5-point scale. Higher scores indicate worse functional ability. Both the original and Spanish versions have demonstrated good reliability, internal consistency, sensitivity to change, and construct validity. |
3 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.
- Vale N, Gandolfi M, Mazzoleni S, Battini E, Dimitrova EK, Gajofatto A, Ferraro F, Castelli M, Camin M, Filippetti M, De Paoli C, Picelli A, Corradi J, Chemello E, Waldner A, Saltuari L, Smania N. Characterization of Upper Limb Impairments at Body Function, Activity, and Participation in Persons With Multiple Sclerosis by Behavioral and EMG Assessment: A Cross-Sectional Study. Front Neurol. 2020 Feb 14;10:1395. doi: 10.3389/fneur.2019.01395. eCollection 2019.
- Jiang R, Westwater ML, Noble S, Rosenblatt M, Dai W, Qi S, Sui J, Calhoun VD, Scheinost D. Associations between grip strength, brain structure, and mental health in > 40,000 participants from the UK Biobank. BMC Med. 2022 Sep 9;20(1):286. doi: 10.1186/s12916-022-02490-2.
- Moreno-Morente G, Hurtado-Pomares M, Sanchez-Perez A, Terol-Cantero MC. Translation, Cross-Cultural Adaptation, and Feasibility of the NHPT-E of Manual Dexterity for the Spanish Population. Healthcare (Basel). 2024 Feb 27;12(5):550. doi: 10.3390/healthcare12050550.
- Walther S, Mittal VA, Stegmayer K, Bohlhalter S. Gesture deficits and apraxia in schizophrenia. Cortex. 2020 Dec;133:65-75. doi: 10.1016/j.cortex.2020.09.017. Epub 2020 Oct 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFMC-MH2025
- IO 50/2024 (Other Identifier: Universidad de Burgos)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The individual participant data (IPD) that underlie the results reported in this study-including anonymized data on motor assessments, functional performance, and demographic variables-will be made available upon reasonable request to qualified researchers.
Requests include a clear research purpose and it is reviewed and approved by the principal investigator and the ethics committee, ensuring data privacy and compliance with relevant regulations. Data will be shared in a de-identified format to protect participant confidentiality.
IPD Sharing Time Frame
The IPD will be made available upon reasonable request to qualified researchers.
Start date for data availability: January 1, 2026
End date for data availability: December 31, 2030
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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