Assessment, SelfNCT04207073
Assessment of Two Point Discrimination
A study testing Mobilization of median nerve in people with Assessment, Self, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
When the studies in the literature are examined, no study has been reached to examine whether median nerve mobilization causes changes in two-point discriminatory values in healthy individuals. Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Assessment, Self
- What is being tested?
- Mobilization of median nerve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2019to 26 Jun 2021
- Phase
- Interventional
- 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 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteers
- Adapt to median nerve mobilization exercise
Who cannot join
- Upper extremity neuromuscular disease
- The presence of neurological disease
- Skin diseases (burn or scar tissue in upper extremity)
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Median Nerve Mobilization on Two Point Discrimination
When the studies in the literature are examined, no study has been reached to examine whether median nerve mobilization causes changes in two-point discriminatory values in healthy individuals. This study aimed to investigate the effect of median nerve mobilization exercise on two-point discrimination in healthy adult male and female participants. Secondly, it was aimed to determine the role of variables such as gender, age, BMI (weight in kilograms, height in meters and weight and height will be combined to report BMI in kg/m^2), smoking, dominant extremity and physical activity level in 2-point discrimination.
Read the detailed description
Two-point discrimination is one of the most important cortical senses that require strong tactile sensitivity and the ability to distinguish two points from one point on the skin. Neural mobilization has been reported to be effective in the nerve-related waist, leg, neck, arm, and plantar heel pain, but there is still insufficient evidence for other neuromusculoskeletal problems. It has been stated that factors such as application technique, type and patient characteristics of mobilization are effective in the treatment and more comprehensive studies should be done on this subject. This study aimed to investigate the effect of median nerve mobilization exercise on two-point discrimination in healthy adult male and female participants.
120 healthy female and male adult individuals (60 females, 60 males) will be included in the study. Individuals will be divided into two groups as female and male (n = 60), and a two-point discrimination test will be performed on the palmar face of both hands from the distal phalanx, forefinger, middle finger and palm. After the evaluation, the participants in both groups were randomly divided into two groups as the exercise group (n = 30) and control group (n = 30). Participants in the exercise group will perform 2 sets of 5 repetitive Median nerve mobilization exercises (total of 20 sessions) per day for 10 days. After the exercise program, the two-point discrimination measures will be repeated in all groups.
- Conditions
- Assessment, Self
- Being tested
- Mobilization of median nerve
- Keywords
- two-point discrimination, neural mobilization, tactile sensation, median nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization of median nerveDevice
Neural mobilization
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention. |
| Exercise group | Experimental | Participants in the exercise group will perform 2 sets of 5 repetitive Median nerve mobilization exercises (total of 20 sessions) per day for 10 days. Receives: Device: Mobilization of median nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-point discrimination
Two-point discrimination test will be performed on the palmar face of both hands from the distal phalanx, forefinger, middle finger and palm.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start23 Dec 2019
- Primary completion24 Apr 2021
- Study completion26 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment, SelfStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Aras, Medipol University
- Investigators
- Candan Algun, Prof., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207073
- Sponsor's protocol ID
- 10840098-604.01.01-E.63690
- Status last verified
- Nov 2021
- First submitted
- 14 Dec 2019
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Median Nerve Mobilization on Two Point Discrimination
- ClinicalTrials.gov ID
- NCT04207073
- Acronym / sponsor ID
- 10840098-604.01.01-E.63690
- Conditions
- Assessment, Self
- Keywords
- two-point discrimination, neural mobilization, tactile sensation, median nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 24 Apr 2021 (actual)
- Study completion
- 26 Jun 2021 (actual)
- First posted
- 20 Dec 2019 (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.
When the studies in the literature are examined, no study has been reached to examine whether median nerve mobilization causes changes in two-point discriminatory values in healthy individuals. This study aimed to investigate the effect of median nerve mobilization exercise on two-point discrimination in healthy adult male and female participants. Secondly, it was aimed to determine the role of variables such as gender, age, BMI (weight in kilograms, height in meters and weight and height will be combined to report BMI in kg/m^2), smoking, dominant extremity and physical activity level in 2-point discrimination.
Detailed description
Two-point discrimination is one of the most important cortical senses that require strong tactile sensitivity and the ability to distinguish two points from one point on the skin. Neural mobilization has been reported to be effective in the nerve-related waist, leg, neck, arm, and plantar heel pain, but there is still insufficient evidence for other neuromusculoskeletal problems. It has been stated that factors such as application technique, type and patient characteristics of mobilization are effective in the treatment and more comprehensive studies should be done on this subject. This study aimed to investigate the effect of median nerve mobilization exercise on two-point discrimination in healthy adult male and female participants.
120 healthy female and male adult individuals (60 females, 60 males) will be included in the study. Individuals will be divided into two groups as female and male (n = 60), and a two-point discrimination test will be performed on the palmar face of both hands from the distal phalanx, forefinger, middle finger and palm. After the evaluation, the participants in both groups were randomly divided into two groups as the exercise group (n = 30) and control group (n = 30). Participants in the exercise group will perform 2 sets of 5 repetitive Median nerve mobilization exercises (total of 20 sessions) per day for 10 days. After the exercise program, the two-point discrimination measures will be repeated in all groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention. |
| Exercise group | Experimental | Device: Mobilization of median nerveParticipants in the exercise group will perform 2 sets of 5 repetitive Median nerve mobilization exercises (total of 20 sessions) per day for 10 days. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Volunteers
- Adapt to median nerve mobilization exercise
Key exclusion criteria (4 listed)
- Upper extremity neuromuscular disease
- The presence of neurological disease
- Skin diseases (burn or scar tissue in upper extremity)
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobilization of median nerveNeural mobilization | Device | Exercise group |
Primary outcome
Two-point discrimination
Time frame: 2 weeks
Two-point discrimination test will be performed on the palmar face of both hands from the distal phalanx, forefinger, middle finger and palm.
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 17 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Candan Algun, Prof. study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization of median nerve in people with Assessment, Self, run by Medipol University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 17 Nov 2021. 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 Turkey (Türkiye). 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?
Two-point discrimination (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2021.