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

NCT ID: NCT06712342

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-12-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NEG

Upper Extremity Focused Neuromuscular Exercise Training

Group Type: EXPERIMENTAL

Neuromuscular Exercise Training

Intervention Type: 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

CEG

Traditional Upper Extremity Exercise Training

Group Type: ACTIVE_COMPARATOR

Conventional Exercise Training

Intervention Type: 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

CG

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Aydın University

OTHER

Sponsor Role: lead

Responsible Party

Uğur OVACIK

PT, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Uğur Ovacık

Role: PRINCIPAL_INVESTIGATOR

Istanbul Aydın University

Ela Tarakcı

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Central Contacts

Uğur Ovacık

Role: CONTACT

ovacikugur@gmail.com

+90 444 1 428

Other Identifiers

2024/125

Identifier Type: -

Identifier Source: org_study_id