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

NCT06712342 | Not Yet Recruiting

• 1 other identifier: 2024/125
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; exercise; function; upper extremity; neuromuscular exercise training; manual dexterity

Outcome Measures

Primary Outcomes (6)

• Nine Hole Peg Test

  To assess unilateral function of the upper extremity

  At the beginning, at the end of 8 weeks and 12 weeks

• Minnesota Manual Dexterity Test

  To assess bilateral upper extremity function

  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.

  At the beginning, at the end of 8 weeks and 12 weeks

• Timed 25-Foot Walk

  To assess lower extremity function

  At the beginning, at the end of 8 weeks and 12 weeks

• Symbol Digit Modalities Test

  To assess cognitive function

  At the beginning, at the end of 8 weeks and 12 weeks

• Hand Dynamometer

  To assess hand grip strength

  At the beginning, at the end of 8 weeks and 12 weeks

Secondary Outcomes (7)

• Hand Held Dynamometer

  At the beginning, at the end of 8 weeks and 12 weeks

• Biodex Balance System

  At the beginning, at the end of 8 weeks and 12 weeks

• Laser-pointer Assisted Angle Reproduction Test

  At the beginning, at the end of 8 weeks and 12 weeks

• Finger Tapping Test

  At the beginning, at the end of 8 weeks and 12 weeks

• Fatigue Severity Scale

  At the beginning, at the end of 8 weeks and 12 weeks

Study Arms (3)

NEG

EXPERIMENTAL

Upper Extremity Focused Neuromuscular Exercise Training

Other: Neuromuscular Exercise Training

CEG

ACTIVE COMPARATOR

Traditional Upper Extremity Exercise Training

Other: Conventional Exercise Training

CG

NO INTERVENTION

Control Group

Interventions

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

NEG

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

CEG

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Definite MS according to McDonald criteria,
• years
• RRMS,
• EDSS \< 4,
• Minimal or moderate upper extremity involvement

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Aydın University: lead

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Uğur Ovacık

  Istanbul Aydın University

  PRINCIPAL INVESTIGATOR

• Ela Tarakcı

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Uğur Ovacık

CONTACT

+90 444 1 428; ovacikugur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: November 30, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 29, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12