Multiple SclerosisNCT05663541
Validity and Reliability of Lower Extremity Position Test in Patients with Multiple Sclerosis
An observational study of Multiple Sclerosis and Sensory Impairments, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Sensory disorders are one of the most important problems in individuals with MS, and these disorders are among the first symptoms of MS. Loss of sense of proprioception is particularly common in patients with MS. Studies show that assessment methods for the quantitative measurement of sensory disorders are lacking. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Sensory Impairments, Proprioceptive Disorders
- What is being tested?
- Lower extremity position test
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2022to 24 Jul 2023
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple sclerosis indivuduals
Who may be able to join
- 20-65 years old
- EDSS score between 0-5
- Person who has not had an attack in the last 1 month or who is not in the attack period
- Person without systemic disease such as hypertension, heart disease, Diabetes Mellitus, hyperlipidemia, malignancy
- Person who has not undergone surgery that restricts balance function in the lower extremity.
- Person without hip, knee and ankle contracture
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- Person who does not have additional neurological disease
- Person who does not use vestibulosupressants or drugs that may cause neuropathy and does not have a history of alcohol use
- To have full cooperation and adaptation to the work
- Individuals who agree to receive treatment will be included in the study.
Who cannot join
- Being younger than 20 years old and over 65 years old
- Being in the attack period
- Hip, knee or ankle contracture
- Being greater than EDSS 5
- Having systemic diseases such as hypertension, heart disease, Diabetes Mellitus, hyperlipidemia, malignancy
- Having an additional neurological disease
- Having a vestibulospressant or drug or alcohol use habit that causes neuropathy
- Not cooperating and adapting to the work
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Romatem Bursa Fizik Tedavi ve Rehabilitasyon Hastanesi
Bursa
About this study
Sensory disorders are one of the most important problems in individuals with MS, and these disorders are among the first symptoms of MS. Loss of sense of proprioception is particularly common in patients with MS. Studies show that assessment methods for the quantitative measurement of sensory disorders are lacking. Especially in the clinic, there is no evaluation method that evaluates the sense of proprioception. Therefore, the aim of this study perform the validity and reliability study of the lower extremity position test to evaluate proprioception sense in individuals with MS.
- Being tested
- Lower extremity position test
- Medical subject headings
- Multiple Sclerosis, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower extremity position testDiagnostic test
Assessing proprioception of the lower extremity of individuals multiple sclerosis
| Study group | Role | What they receive |
|---|---|---|
| Patient with multiple sclerosis | Patient with multiple sclerosis Receives: Diagnostic Test: Lower extremity position test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensorial Assessment-1
Lower Extremity Position test
Measured: through study completion, an average of 1 year
Sensorial Assessment-2
Kinesthesia (Inclinometer)
Measured: through study completion, an average of 1 year
Balance Assessment-1
Static Balance via single leg stance
Measured: through study completion, an average of 1 year
Balance Assessment-2
Dynamic Balance via time up and go
Measured: through study completion, an average of 1 year
Walking Speed Assessment
The 10 meter walk test
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Demographic Assessment
Demographic form
Measured: through study completion, an average of 1 year
Expanded Disability Status Scale (EDSS)
Ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start24 Oct 2022
- Primary completion6 May 2023
- Study completion24 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celal Batuhan Güneysu, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663541
- Sponsor's protocol ID
- E-60116787-020-238650
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2022
- Last updated
- 5 Dec 2024
- 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 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Lower Extremity Position Test in Patients with Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05663541
- Acronym / sponsor ID
- E-60116787-020-238650
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 6 May 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 23 Dec 2022 (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.
Sensory disorders are one of the most important problems in individuals with MS, and these disorders are among the first symptoms of MS. Loss of sense of proprioception is particularly common in patients with MS. Studies show that assessment methods for the quantitative measurement of sensory disorders are lacking. Especially in the clinic, there is no evaluation method that evaluates the sense of proprioception. Therefore, the aim of this study perform the validity and reliability study of the lower extremity position test to evaluate proprioception sense in individuals with MS.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with multiple sclerosis | – | Diagnostic Test: Lower extremity position testPatient with multiple sclerosis |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple sclerosis indivuduals
Key inclusion criteria (10 listed)
- 20-65 years old
- EDSS score between 0-5
- Person who has not had an attack in the last 1 month or who is not in the attack period
- Person without systemic disease such as hypertension, heart disease, Diabetes Mellitus, hyperlipidemia, malignancy
- Person who has not undergone surgery that restricts balance function in the lower extremity.
Key exclusion criteria (8 listed)
- Being younger than 20 years old and over 65 years old
- Being in the attack period
- Hip, knee or ankle contracture
- Being greater than EDSS 5
- Having systemic diseases such as hypertension, heart disease, Diabetes Mellitus, hyperlipidemia, malignancy
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 |
|---|---|---|
| Lower extremity position testAssessing proprioception of the lower extremity of individuals multiple sclerosis | Diagnostic test | Patient with multiple sclerosis |
Primary outcome
Sensorial Assessment-1
Time frame: through study completion, an average of 1 year
Lower Extremity Position test
Sensorial Assessment-2
Time frame: through study completion, an average of 1 year
Kinesthesia (Inclinometer)
Balance Assessment-1
Time frame: through study completion, an average of 1 year
Static Balance via single leg stance
Balance Assessment-2
Time frame: through study completion, an average of 1 year
Dynamic Balance via time up and go
Walking Speed Assessment
Time frame: through study completion, an average of 1 year
The 10 meter walk test
2 secondary outcomes
Demographic Assessment
Time frame: through study completion, an average of 1 year
Expanded Disability Status Scale (EDSS)
Time frame: through study completion, an average of 1 year
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 5 Dec 2024.
- 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.
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 Multiple Sclerosis and Sensory Impairments, run by Pamukkale 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 10 inclusion and 8 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 5 Dec 2024. 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?
Sensorial Assessment-1 (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. 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 5 Dec 2024.