Clinical trial NCT06949449: Upper Limb Function in Mental Health Disorders
Official title: Upper Limb Functional Capacity in Individuals Diagnosed With Mental Disorders: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health
Multiple Sclerosis
Keywords: mental disorders
upper extremity
hand strength
motor skills
hand
Lead sponsor: Universidad de Burgos
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nine Hole Peg Test (NHPT)
timeFrame: 3 weeks
measure: Box and Block Test (BBT)
timeFrame: 3 weeks
measure: Digital Hand Dynamometer
timeFrame: 3 weeks
measure: Semmes-Weinstein Monofilament Test
timeFrame: 3 weeks
measure: Two-Point Discrimination Test (Touch-Test)
timeFrame: 3 weeks
measure: QuickDASH Questionnaire
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: University of Burgos
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.