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Completed

NCT Number: NCT06949449

Upper Limb Function in Mental Health Disorders

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.

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Key information

Conditions

Mental Health Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mental Disorders Multiple Sclerosis Nervous System Diseases Personal Satisfaction Psychological Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Burgos

Burgos, 09001, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Burgos

Other

Registry information

Official study title

Upper Limb Functional Capacity in Individuals Diagnosed With Mental Disorders: A Cross-Sectional Study

Acronym: UFMC-MH2025

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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