Effects of Thumb Manipulation on Hand Grip Strength, Function, and Sensation (THUMBFUN)

July 7, 2025 updated by: SEFA HAKTAN HATIK

The Effects of Thumb Manipulation on Hand Grip Strength, Hand Function, and Sensory Parameters

This randomized controlled study will aim to investigate the effects of thumb manipulation on hand grip strength, function, and sensation in healthy individuals. A total of 60 volunteers aged between 18 and 50 years will be recruited from Ortadağ Special Education and Rehabilitation Center. Participants will be randomly assigned to either a chiropractic manipulation group (n=30) or a control group (n=30), with an equal distribution of males and females in each group. The intervention group will receive thumb manipulation twice weekly for 4 weeks, while the control group will not receive any intervention. Outcome measures will include two-point discrimination (assessed with a discriminator), hand grip strength (measured using a dynamometer), pinch strength (evaluated with a pinch meter), and hand function (measured by the Duruöz Hand Index). Statistical analyses will be performed with a significance level set at p<0.05. It is expected that participants in the manipulation group will show greater improvements in all measured parameters compared to the control group, suggesting a positive effect of thumb manipulation on hand-related sensorimotor functions in healthy individuals.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be designed as a randomized controlled clinical trial to evaluate the effects of thumb manipulation on hand grip strength, functional ability, and sensory parameters in healthy individuals. Sixty volunteers aged between 18 and 50 years will be recruited from Ortadağ Special Education and Rehabilitation Center. After anthropometric assessments, participants will be randomly assigned into two groups: a chiropractic manipulation group (n=30) and a control group (n=30), with equal numbers of males and females in each group.

The intervention group will undergo thumb manipulation performed by a trained physiotherapist twice a week for four weeks. The control group will not receive any intervention during this period. All participants will be evaluated at baseline, at the end of the 4-week intervention, and at follow-up.

Outcome measures will include:

Hand grip strength, measured using a hand dynamometer, Pinch strength, assessed with a pinch meter on the thumb, index, and middle fingers, Two-point discrimination, evaluated on the thumbs using a discriminator tool, Hand function, assessed using the Duruöz Hand Index. This study will aim to determine whether a short-term thumb manipulation protocol can lead to measurable improvements in sensory and motor functions of the hand in a healthy population. The findings may provide a basis for future research involving clinical populations with hand dysfunction.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Sinop, Turkey
        • Sinop University
        • Contact:
        • Principal Investigator:
          • SEFA H HATIK, Asst. Prof.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged between 18 and 50
  • Willing to participate in the study
  • Have signed the informed consent form
  • Able to use verbal and written communication skills

Exclusion Criteria:

  • Having contraindications that may prevent manipulation
  • Having a history of congenital or acquired orthopedic or neurological conditions affecting the upper extremity
  • Having a history of rheumatological diseases
  • Having a history of trauma or surgery affecting the upper extremity

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chiropractic Manipulation Group (CMG)
Participants in this group will receive chiropractic manipulation specifically applied to the thumb. The intervention will be administered twice a week for 4 weeks by a trained physiotherapist experienced in manual therapy techniques. Each session will involve standardized manipulation techniques aimed at improving thumb mobility, hand grip strength, sensory function, and overall hand function. No additional interventions or therapies will be provided during the study period.
Other: Thumb Manipulation
This intervention consists of chiropractic manipulation techniques applied specifically to the thumb joint. The manipulation will be performed by a trained physiotherapist twice weekly for 4 weeks. The procedure aims to improve thumb joint mobility, hand grip strength, sensory function, and overall hand function. Each session includes standardized manual therapy maneuvers targeting the thumb's range of motion and soft tissue mobility without the use of any devices or medications. The intervention differs from other manual therapies by focusing solely on the thumb region.
Other Names:
  • Chiropractic Thumb Manipulation
  • Manual Thumb Mobilization
No Intervention: Control Group (CG)
Participants in the control group will not receive any intervention or treatment during the 4-week study period. They will continue their usual daily activities without any specific therapy applied. Outcome measurements will be conducted at the same time points as the intervention group to allow for comparison.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duruoz Hand Index
Time Frame: T0 (Baseline, before intervention), T1 (Week 2 of intervention), and T2 (Week 4, end of intervention
The Duruöz Hand Index is a validated self-reported questionnaire used to assess hand function and disability in daily activities. It includes 18 items covering various tasks such as dressing, hygiene, kitchen activities, and carrying objects. Each item is scored on a scale from 0 (no difficulty) to 5 (unable to perform), with higher scores indicating greater hand disability.
T0 (Baseline, before intervention), T1 (Week 2 of intervention), and T2 (Week 4, end of intervention
Two-Point Discrimination Test
Time Frame: T0 (Baseline, before intervention), T1 (Week 2 of intervention), and T2 (Week 4, end of intervention)
The Two-Point Discrimination Test is used to evaluate sensory perception and tactile acuity. It measures the smallest distance at which two points of contact can be perceived as separate. In this study, the test will be applied to the thumb (right and left) using a standardized discriminator tool. Lower discrimination distances indicate better sensory perception. The test provides objective data on changes in cutaneous sensory function.
T0 (Baseline, before intervention), T1 (Week 2 of intervention), and T2 (Week 4, end of intervention)
Pinchmeter
Time Frame: T0 (Baseline, before intervention), T1 (Week 2 of intervention), and T2 (Week 4, end of intervention)
Pinch strength will be measured using a standardized pinchmeter to assess lateral, palmar, and tip-to-tip pinch strength in the thumb, index, and middle fingers of both hands. The test will provide quantitative data on fine motor strength and thumb function. Higher values indicate increased pinch strength. The measurement will be used to evaluate the effect of thumb manipulation on hand function.
T0 (Baseline, before intervention), T1 (Week 2 of intervention), and T2 (Week 4, end of intervention)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SEFA HAKTAN HATIK

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SEFA H HATIK, Sinop University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 6, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMT0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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