Multiple SclerosisNCT06712342
Effects of Upper Extremity-Focused Neuromuscular Training in People With Multiple Sclerosis
A study testing Neuromuscular Exercise Training and Conventional Exercise Training in people with Multiple Sclerosis, run by Istanbul Aydın University.
Trial summary
The effectiveness of upper extremity focused neuromuscular exercise training in early stage people with MS will be investigated. People with MS enrolled in the study will be randomly assigned to three groups: Neuromuscular Exercise Group (NEG), Conventional Exercise Group (CEG), and Control Group (CG). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Neuromuscular Exercise Training and Conventional Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2024to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Definite MS according to McDonald criteria,
- 18-64 years
- RRMS,
- EDSS < 4,
- Minimal or moderate upper extremity involvement
Who cannot join
- Having an attack in the last three months,
- Mini Mental Test <24 or visual deficit,
- Other medical conditions accompanying MS (cardiac, orthopedic or rheumatic, etc.),
- Being pregnant or breastfeeding,
- Doing regular exercise - receiving physiotherapy,
- Having spasticity of 2 or more in the upper extremity
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Upper Extremity-Focused Neuromuscular Exercise Training on Physical and Cognitive Functions in People With Multiple Sclerosis (NExTUp)
The effectiveness of upper extremity focused neuromuscular exercise training in early stage people with MS will be investigated. People with MS enrolled in the study will be randomly assigned to three groups: Neuromuscular Exercise Group (NEG), Conventional Exercise Group (CEG), and Control Group (CG). All three groups will be assessed with primary and secondary outcome measures at baseline, week 8, and week 12. NEG, CEG, and CG will be initially assessed for upper extremity function, cognitive function, lower extremity function, grip strength, proximal muscle strength, sensation, coordination, fatigue, postural sway, and core muscle strength and endurance. Then, NEG will receive clinically supervised upper extremity focused neuromuscular exercise training with a minimum of 60 minutes of session time, 2 days a week for 8 weeks. This exercise training includes steps for postural control, weight transfer, proximal and distal muscle strengthening, proprioception, coordination and reaction speed. Similarly, CEG will receive clinically supervised traditional upper extremity exercise training, twice a week for 8 weeks, with a minimum of 60 minutes of session time. This exercise training includes strengthening with the band and manuel dexterity exercises. In both groups, stretching and mobility exercises will be added to the warm-up and cool-down exercises before and after the program. During this process, CG will be on the waiting list. At the end of 8 weeks, all three groups will be re-evaluated. After the exercise training, follow-up will be done and evaluations will be repeated in the 12th week. This study will provide evidence on the effects of upper extremity-focused neuromuscular exercise training on physical and cognitive functions in early-stage people with MS compared to traditional treatment approaches.
- Conditions
- Multiple Sclerosis
- Being tested
- Neuromuscular Exercise Training, Conventional Exercise Training
- Keywords
- Multiple Sclerosis, exercise, function, upper extremity, neuromuscular exercise training, manual dexterity
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Exercise TrainingOther
This group will receive neuromuscular exercise training with 60-75 minute sessions per day, 2 days a week, for 8 weeks.
Warm-up Program - 5 minutes Postural Control-Weight Transfer - 10-15 minutes Strength Training - 30-35 minutes Proprioception - Coordination - Reaction Speed 10-15 minutes Cool-down Program - 5 minutes
Conventional Exercise TrainingOther
This group will be given traditional strength exercise training consisting of 60-75 minute sessions per day, 2 days per week for 8 weeks.
Warm-up Program - 5 minutes Strength Training - 30-35 minutes Manuel Dexterity - 15-20 minutes Cool-down Program - 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| NEG | Experimental | Upper Extremity Focused Neuromuscular Exercise Training Receives: Other: Neuromuscular Exercise Training |
| CEG | Active comparator | Traditional Upper Extremity Exercise Training Receives: Other: Conventional Exercise Training |
| CG | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine Hole Peg Test
To assess unilateral function of the upper extremity
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Minnesota Manual Dexterity Test
To assess bilateral upper extremity function
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Manual Ability Measure-36
To assess upper extremity function. A higher score indicates better hand function.
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Timed 25-Foot Walk
To assess lower extremity function
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Symbol Digit Modalities Test
To assess cognitive function
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Hand Dynamometer
To assess hand grip strength
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Secondary outcomes (7)
Hand Held Dynamometer
To assess elbow muscle strength
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Biodex Balance System
To assess postural sway
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Laser-pointer Assisted Angle Reproduction Test
To assess of shoulder proprioception
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Finger Tapping Test
To assess upper extremity coordination
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Fatigue Severity Scale
To assess fatigue severity. A high score indicates high fatigue severity.
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Plank
To assess core muscle endurance
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Curl-up
To assess core muscle strength
Measured: At the beginning, at the end of 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start30 Nov 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion29 Dec 2025 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uğur OVACIK, Istanbul Aydın University
- Investigators
- Uğur Ovacık, Principal investigator, Istanbul Aydın UniversityEla Tarakcı, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712342
- Sponsor's protocol ID
- 2024/125
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 4 Dec 2024
- 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Extremity-Focused Neuromuscular Exercise Training on Physical and Cognitive Functions in People With Multiple Sclerosis (NExTUp)
- ClinicalTrials.gov ID
- NCT06712342
- Acronym / sponsor ID
- 2024/125
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, exercise, function, upper extremity, neuromuscular exercise training, manual dexterity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 29 Dec 2025 (estimated)
- First posted
- 2 Dec 2024 (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.
The effectiveness of upper extremity focused neuromuscular exercise training in early stage people with MS will be investigated. People with MS enrolled in the study will be randomly assigned to three groups: Neuromuscular Exercise Group (NEG), Conventional Exercise Group (CEG), and Control Group (CG). All three groups will be assessed with primary and secondary outcome measures at baseline, week 8, and week 12. NEG, CEG, and CG will be initially assessed for upper extremity function, cognitive function, lower extremity function, grip strength, proximal muscle strength, sensation, coordination, fatigue, postural sway, and core muscle strength and endurance. Then, NEG will receive clinically supervised upper extremity focused neuromuscular exercise training with a minimum of 60 minutes of session time, 2 days a week for 8 weeks. This exercise training includes steps for postural control, weight transfer, proximal and distal muscle strengthening, proprioception, coordination and reaction speed. Similarly, CEG will receive clinically supervised traditional upper extremity exercise training, twice a week for 8 weeks, with a minimum of 60 minutes of session time. This exercise training includes strengthening with the band and manuel dexterity exercises. In both groups, stretching and mobility exercises will be added to the warm-up and cool-down exercises before and after the program. During this process, CG will be on the waiting list. At the end of 8 weeks, all three groups will be re-evaluated. After the exercise training, follow-up will be done and evaluations will be repeated in the 12th week. This study will provide evidence on the effects of upper extremity-focused neuromuscular exercise training on physical and cognitive functions in early-stage people with MS compared to traditional treatment approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NEG | Experimental | Other: Neuromuscular Exercise TrainingUpper Extremity Focused Neuromuscular Exercise Training |
| CEG | Active comparator | Other: Conventional Exercise TrainingTraditional Upper Extremity Exercise Training |
| CG | No intervention | –Control Group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Definite MS according to McDonald criteria,
- 18-64 years
- RRMS,
- EDSS < 4,
- Minimal or moderate upper extremity involvement
Key exclusion criteria (6 listed)
- Having an attack in the last three months,
- Mini Mental Test <24 or visual deficit,
- Other medical conditions accompanying MS (cardiac, orthopedic or rheumatic, etc.),
- Being pregnant or breastfeeding,
- Doing regular exercise - receiving physiotherapy,
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 |
|---|---|---|
| Neuromuscular Exercise TrainingThis group will receive neuromuscular exercise training with 60-75 minute sessions per day, 2 days a week, for 8 weeks. Warm-up Program - 5 minutes Postural Control-Weight Transfer - 10-15 minutes Strength Training - 30-35 minutes Proprioception - Coordination - Reaction Speed 10-15 minutes Cool-down Program - 5 minutes | Other | NEG |
| Conventional Exercise TrainingThis group will be given traditional strength exercise training consisting of 60-75 minute sessions per day, 2 days per week for 8 weeks. Warm-up Program - 5 minutes Strength Training - 30-35 minutes Manuel Dexterity - 15-20 minutes Cool-down Program - 5 minutes | Other | CEG |
Primary outcome
Nine Hole Peg Test
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
To assess unilateral function of the upper extremity
Minnesota Manual Dexterity Test
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
To assess bilateral upper extremity function
Manual Ability Measure-36
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
To assess upper extremity function. A higher score indicates better hand function.
Timed 25-Foot Walk
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
To assess lower extremity function
Symbol Digit Modalities Test
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
To assess cognitive function
Hand Dynamometer
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
To assess hand grip strength
7 secondary outcomes
Hand Held Dynamometer
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
Biodex Balance System
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
Laser-pointer Assisted Angle Reproduction Test
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
Finger Tapping Test
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
Fatigue Severity Scale
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
Plank
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
Curl-up
Time frame: At the beginning, at the end of 8 weeks and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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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.
Uğur Ovacık principal investigator
Istanbul Aydın University
Ela Tarakcı study director
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Exercise Training and Conventional Exercise Training in people with Multiple Sclerosis, run by Istanbul Aydın University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uğur Ovacık (+90 444 1 428, ovacikugur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine Hole Peg Test (time frame: At the beginning, at the end of 8 weeks and 12 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?
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 4 Dec 2024.