Upper Limb Function in Mental Health Disorders

NCT06949449 | Completed

• 2 other identifiers: UFMC-MH2025IO 50/2024
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health; Multiple Sclerosis

Keywords

mental disorders; upper extremity; hand strength; motor skills; hand

Outcome Measures

Primary Outcomes (6)

• Nine Hole Peg Test (NHPT)

  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)

  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

  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

  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)

  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

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)
• Aged between 18 and 65 years.
• Ability to follow instructions and communicate effectively, also defined by a minimum MMSE score of 23.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Burgos: lead

Study Sites (1)

University of Burgos

Burgos, Burgos, 09001, Spain

Location

Related Publications (5)

• 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.

  PMID: 36076200 BACKGROUND

• 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.

  PMID: 8024419 BACKGROUND

• 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.

  PMID: 38470661 BACKGROUND

• 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.

  PMID: 33099076 BACKGROUND

• 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.

  PMID: 32116983 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Multiple Sclerosis; Mental Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 29, 2025
• Study Start: October 1, 2024
• Primary Completion: January 25, 2025
• Study Completion: March 25, 2025
• Last Updated: April 29, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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
• 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.

Locations

ES (1)