Clinical trial NCT06712342: Effects of Upper Extremity-Focused Neuromuscular Training in People With Multiple Sclerosis
Official title: Effects of Upper Extremity-Focused Neuromuscular Exercise Training on Physical and Cognitive Functions in People With Multiple Sclerosis (NExTUp)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
exercise
function
upper extremity
neuromuscular exercise training
manual dexterity
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* Definite MS according to McDonald criteria,
* 18-64 years
* RRMS,
* EDSS \< 4,
* Minimal or moderate upper extremity involvement

Exclusion Criteria:

* 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

Primary outcomes:
measure: Nine Hole Peg Test
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
measure: Minnesota Manual Dexterity Test
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
measure: Manual Ability Measure-36
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
measure: Timed 25-Foot Walk
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
measure: Symbol Digit Modalities Test
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
measure: Hand Dynamometer
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
Secondary outcomes:
measure: Hand Held Dynamometer
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
measure: Biodex Balance System
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
measure: Laser-pointer Assisted Angle Reproduction Test
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
measure: Finger Tapping Test
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
measure: Fatigue Severity Scale
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
measure: Plank
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
measure: Curl-up
timeFrame: At the beginning, at the end of 8 weeks and 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul Aydın University
name: Uğur Ovacık
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Ela Tarakcı
role: STUDY_DIRECTOR
References: