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NCT Number: NCT06712342

Effects of Upper Extremity-Focused Neuromuscular Training in People With Multiple Sclerosis

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Exercise Training

Other

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 Training

Other

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

Primary outcomes

  1. 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

  2. Minnesota Manual Dexterity Test

    Time frame: At the beginning, at the end of 8 weeks and 12 weeks

    To assess bilateral upper extremity function

  3. 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.

  4. Timed 25-Foot Walk

    Time frame: At the beginning, at the end of 8 weeks and 12 weeks

    To assess lower extremity function

  5. Symbol Digit Modalities Test

    Time frame: At the beginning, at the end of 8 weeks and 12 weeks

    To assess cognitive function

  6. Hand Dynamometer

    Time frame: At the beginning, at the end of 8 weeks and 12 weeks

    To assess hand grip strength

Secondary outcomes

  1. Hand Held Dynamometer

    Time frame: At the beginning, at the end of 8 weeks and 12 weeks

    To assess elbow muscle strength

  2. Biodex Balance System

    Time frame: At the beginning, at the end of 8 weeks and 12 weeks

    To assess postural sway

  3. Laser-pointer Assisted Angle Reproduction Test

    Time frame: At the beginning, at the end of 8 weeks and 12 weeks

    To assess of shoulder proprioception

  4. Finger Tapping Test

    Time frame: At the beginning, at the end of 8 weeks and 12 weeks

    To assess upper extremity coordination

  5. Fatigue Severity Scale

    Time frame: At the beginning, at the end of 8 weeks and 12 weeks

    To assess fatigue severity. A high score indicates high fatigue severity.

  6. Plank

    Time frame: At the beginning, at the end of 8 weeks and 12 weeks

    To assess core muscle endurance

  7. Curl-up

    Time frame: At the beginning, at the end of 8 weeks and 12 weeks

    To assess core muscle strength

Study contacts

Contact information is provided by the study sponsor or research team.

Uğur Ovacık

CONTACT

[email protected]

+90 444 1 428

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Official study title

Effects of Upper Extremity-Focused Neuromuscular Exercise Training on Physical and Cognitive Functions in People With Multiple Sclerosis (NExTUp)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 2, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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