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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Neuromuscular Exercise Training; Other: Conventional Exercise Training

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Uğur Ovacık; Phone Number: +90 444 1 428; Email: ovacikugur@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NEG; Upper Extremity Focused Neuromuscular Exercise Training	Other: Neuromuscular Exercise Training; 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
Active Comparator: CEG; Traditional Upper Extremity Exercise Training	Other: Conventional Exercise Training; 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
No Intervention: CG; Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Held Dynamometer	To assess elbow muscle strength	At the beginning, at the end of 8 weeks and 12 weeks
Biodex Balance System	To assess postural sway	At the beginning, at the end of 8 weeks and 12 weeks
Laser-pointer Assisted Angle Reproduction Test	To assess of shoulder proprioception	At the beginning, at the end of 8 weeks and 12 weeks
Finger Tapping Test	To assess upper extremity coordination	At the beginning, at the end of 8 weeks and 12 weeks
Plank	To assess core muscle endurance	At the beginning, at the end of 8 weeks and 12 weeks
Curl-up	To assess core muscle strength	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.	At the beginning, at the end of 8 weeks and 12 weeks

Collaborators and Investigators

• Sponsor: Istanbul Aydın University
• Investigators: Principal Investigator: Uğur Ovacık, Istanbul Aydın University; Study Director: Ela Tarakcı, Istanbul University - Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 29, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 1, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; exercise; function; upper extremity; manual dexterity; neuromuscular exercise training
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2024/125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No