Multiple SclerosisNCT06982833
Trunk Restraint in Multiple Sclerosis
A study testing Trunk restraint in people with Multiple Sclerosis and Healthy Control, run by Zonguldak Bulent Ecevit University at 2 sites in Turkey (Türkiye).
Trial summary
This study examined the effect of trunk restraint on upper extremity functionality in patients with Multiple Sclerosis (MS).The study included 66 MS patients over the age of 18 and 30 healthy individuals. Participants' upper extremity functions were assessed. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Healthy Control
- What is being tested?
- Trunk restraint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 15 Apr 2025
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Being diagnosed with MS
- Volunteering
Who cannot join
- Having any additional disease or disorder of the upper extremity or trunk (such as disc herniation, fracture)
- Having any additional neurological disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Arzucan Toksal
Zonguldak
Zonguldak Bulent Ecevit University
Zonguldak
About this study
Official title: Investigation of the Effect of Trunk Restraint on Upper Extremity Functionality in Individuals With Multiple Sclerosis
This study examined the effect of trunk restraint on upper extremity functionality in patients with Multiple Sclerosis (MS).The study included 66 MS patients over the age of 18 and 30 healthy individuals. Participants' upper extremity functions were assessed. Their trunks were then restrained and their upper extremity functions were assessed again. The patients' level of disability (EDSS), trunk control (Trunk Impairment Scale - TIS), upper extremity functionality (Nine Hole Peg Test- 9HPT), were evaluated.
- Conditions
- Multiple Sclerosis, Healthy Control
- Being tested
- Trunk restraint
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk restraintOther
Participants were seated in a chair with a standard sitting height of 26 centimeters. After completing the 9-Hole Peg Test with their trunks free on a table of appropriate height so that their trunks would not flexion, they were secured to the chair crosswise in front of their chest with the help of a non-elastic but firm enough belt that would not cause discomfort to the person. Participants completed the 9-DPT with their trunks constrained.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis | Experimental | Patients and healthy individuals first filled out the demographic and clinical information form. Then, the Trunk Impairment Scale was evaluated. Participants performed 9DPT with their trunks free and again with their trunks restrained. Receives: Other: Trunk restraint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Disability Status Scale (EDSS)
EDSS was used to determine the patients' level of disability. EDSS is most commonly used to assess the level of disability in persons with MS. In this scale pyramidal, cerebral, cerebellar, brainstem, visual and sensory subparameters are evaluated it consists of ordinal rating system ranging from 0 (normal neurological status) to 10 (death due to MS) in 0.5 increments interval (when reaching EDSS 1). The lower scale values of the EDSS measureimpairments based on the neurological examination, while the upper range of the scale (> EDSS 6) measures handicaps of patients with MS. The determination of EDSS 4 - 6 is heavily dependent on aspects of walking ability.
Measured: up to 6 weeks
Trunk Impairment Scale (TIS)
This scale used to evaluate the trunk control of the participants, TIS contains static sitting balance, dynamic sitting balance, and coordination. The total score of this scale is from 0 to 23 and a high score indicates better trunk control.
The patients were placed in the standard sitting position for the test and the parameters were applied. Standart position is such that the knees are flexed at 90 degrees, without back support, with the hands and forearms on the thighs and the feet in contact with the ground.
Measured: up to 6 weeks
Nine-Hole Peg Test (9HPT)
It is a short, standardized, quantitative test used to evaluate upper extremity function. In the test, patients are asked to pick up nine wooden pegs from a platform as quickly as possible and then place them back into the holes.In our study, the test was conducted twice for both the dominant and non-dominant hands, and the average completion time was recorded.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start10 Mar 2025
- Primary completion10 Apr 2025
- Study completion15 Apr 2025
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.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- MS patients and their age-matched healthy control group were evaluated.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZUCAN TOKSAL UÇAR, Zonguldak Bulent Ecevit University
- Investigators
- Güngör Beyza Özvar Şenöz, PhD, Principal investigator, Yuksek Ihtisas UniversityBilge Piri Çınar, Assoc. Prof., Principal investigator, Samsun UniversityMustafa Açıkgöz, Assoc. Prof, Study director, Zonguldak Bulent Ecevit UniversityNursena Ceylan, Principal investigator, Zonguldak Bulent Ecevit UniversityArzucan Toksal Uçar, Principal investigator, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982833
- Sponsor's protocol ID
- Trunk Restraint
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Trunk Restraint on Upper Extremity Functionality in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06982833
- Acronym / sponsor ID
- Trunk Restraint
- Conditions
- Multiple Sclerosis, Healthy Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 21 May 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.
This study examined the effect of trunk restraint on upper extremity functionality in patients with Multiple Sclerosis (MS).The study included 66 MS patients over the age of 18 and 30 healthy individuals. Participants' upper extremity functions were assessed. Their trunks were then restrained and their upper extremity functions were assessed again. The patients' level of disability (EDSS), trunk control (Trunk Impairment Scale - TIS), upper extremity functionality (Nine Hole Peg Test- 9HPT), were evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MS patients and their age-matched healthy control group were evaluated.
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis | Experimental | Other: Trunk restraintPatients and healthy individuals first filled out the demographic and clinical information form. Then, the Trunk Impairment Scale was evaluated. Participants performed 9DPT with their trunks free and again with their trunks restrained. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being over 18 years old
- Being diagnosed with MS
- Volunteering
Key exclusion criteria (2 listed)
- Having any additional disease or disorder of the upper extremity or trunk (such as disc herniation, fracture)
- Having any additional neurological disease
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 |
|---|---|---|
| Trunk restraintParticipants were seated in a chair with a standard sitting height of 26 centimeters. After completing the 9-Hole Peg Test with their trunks free on a table of appropriate height so that their trunks would not flexion, they were secured to the chair crosswise in front of their chest with the help of a non-elastic but firm enough belt that would not cause discomfort to the person. Participants completed the 9-DPT with their trunks constrained. | Other | Multiple Sclerosis |
Primary outcome
Expanded Disability Status Scale (EDSS)
Time frame: up to 6 weeks
EDSS was used to determine the patients' level of disability. EDSS is most commonly used to assess the level of disability in persons with MS. In this scale pyramidal, cerebral, cerebellar, brainstem, visual and sensory subparameters are evaluated it consists of ordinal rating system ranging from 0 (normal neurological status) to 10 (death due to MS) in 0.5 increments interval (when reaching EDSS 1). The lower scale values of the EDSS measureimpairments based on the neurological examination, while the upper range of the scale (> EDSS 6) measures handicaps of patients with MS. The determination of EDSS 4 - 6 is heavily dependent on aspects of walking ability.
Trunk Impairment Scale (TIS)
Time frame: up to 6 weeks
This scale used to evaluate the trunk control of the participants, TIS contains static sitting balance, dynamic sitting balance, and coordination. The total score of this scale is from 0 to 23 and a high score indicates better trunk control. The patients were placed in the standard sitting position for the test and the parameters were applied. Standart position is such that the knees are flexed at 90 degrees, without back support, with the hands and forearms on the thighs and the feet in contact with the ground.
Nine-Hole Peg Test (9HPT)
Time frame: up to 6 weeks
It is a short, standardized, quantitative test used to evaluate upper extremity function. In the test, patients are asked to pick up nine wooden pegs from a platform as quickly as possible and then place them back into the holes.In our study, the test was conducted twice for both the dominant and non-dominant hands, and the average completion time was recorded.
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 21 May 2025.
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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.
Güngör Beyza Özvar Şenöz, PhD principal investigator
Yuksek Ihtisas University
Bilge Piri Çınar, Assoc. Prof. principal investigator
Samsun University
Mustafa Açıkgöz, Assoc. Prof study director
Zonguldak Bulent Ecevit University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trunk restraint in people with Multiple Sclerosis and Healthy Control, run by Zonguldak Bulent Ecevit University at 2 sites 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 3 inclusion and 2 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 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Expanded Disability Status Scale (EDSS) (time frame: up to 6 weeks). The study lists 3 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 21 May 2025.