Mental HealthUFMC-MH2025NCT06949449
Upper Limb Function in Mental Health Disorders
An observational study of Mental Health and Multiple Sclerosis, run by Universidad de Burgos at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Multiple Sclerosis
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2024to 25 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health, Multiple Sclerosis
- Keywords
- mental disorders, upper extremity, hand strength, motor skills, hand
- Medical subject headings
- Psychological Well-Being, Multiple Sclerosis, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Oct 2024
- Primary completion25 Jan 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949449
- Sponsor's protocol ID
- UFMC-MH2025
- Other IDs
- IO 50/2024
- Acronym
- UFMC-MH2025
- Status last verified
- Nov 2024
- First submitted
- 8 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36076200Desrosiers 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.
PubMed 8024419Moreno-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.
PubMed 38470661Walther 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.
PubMed 33099076Vale 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.
PubMed 32116983
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb Functional Capacity in Individuals Diagnosed With Mental Disorders: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06949449
- Acronym / sponsor ID
- UFMC-MH2025 / UFMC-MH2025
- Conditions
- Mental Health, Multiple Sclerosis
- Keywords
- mental disorders, upper extremity, hand strength, motor skills, hand
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Results publication: PubMed 36076200Jiang 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.
- Results publication: PubMed 8024419Desrosiers 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.
- Results publication: PubMed 38470661Moreno-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.
- Results publication: PubMed 33099076Walther 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.
- Results publication: PubMed 32116983Vale 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Mental Health
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Multiple Sclerosis, run by Universidad de Burgos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine Hole Peg Test (NHPT) (time frame: 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06949449, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.