Upper Limb Function in Mental Health Disorders (UFMC-MH2025)

April 21, 2025 updated by: Universidad de Burgos

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

Completed

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

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Burgos, Spain, 09001
        • University of Burgos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).
CONTROL GROUP
Participants without any diagnosed mental disorder. Assessed using the same measures to serve as a baseline for comparison with the MD group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nine Hole Peg Test (NHPT)
Time Frame: 3 weeks

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
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
Digital Hand Dynamometer
Time Frame: 3 weeks

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
Semmes-Weinstein Monofilament Test
Time Frame: 3 weeks

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
Two-Point Discrimination Test (Touch-Test)
Time Frame: 3 weeks

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
QuickDASH Questionnaire
Time Frame: 3 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

January 25, 2025

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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

Qualified researchers affiliated with academic institutions, healthcare organizations, or research centers will be eligible to request access to the individual participant data (IPD) and supporting documentation. Access will be granted for non-commercial, scientific research purposes only.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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