Trunk Rehabilitation Compared to Core Stability in Patients With Multiple Sclerosis

NCT ID: NCT06447571

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-12-31

Brief Summary

BACKGROUND Balance, gait, community mobility, and risk of falls are often associated with trunk impairment among people with Multiple Sclerosis (PwMS). Consequently, there is a pressing need for interventions addressing these concerns and exploring the potential effects of trunk rehabilitation.

LONG-TERM GOAL Offering guidance for effective plan selection, potentially included in rehabilitation guidelines for PwMS.

HYPOTHESIS Trunk exercises performed in multiplanar movement on unstable surfaces incorporated with dual-tasks (DT) could improve the functional outcomes more than standard one-plane core stability exercises.

SPECIFIC AIMS Investigating the effectiveness of trunk rehabilitation in PwMS and determining the optimal intervention strategy.

METHODS 50 PwMS randomly assigned into two groups. Trunk Group received trunk exercises on unstable surfaces with DT training, while the Core Group underwent standard one-plane core stability exercises on stable surfaces without DT. Additionally, both received conventional treatment. Primary outcome was the trunk impairment scale (TIS). Secondary outcomes included the Berg balance scale (BBS), Timed Up and Go (TUG), Modified Falls Efficacy (FES), Modified Fatigue Impact Scale (MFIS), Hospital Anxiety and Depression Scale (HADS), and Reintegration to Normal Living Index (RNLI).

SIGNIFICANCE Enhancing our understanding of trunk exercises' benefits and providing valuable guidance to clinicians for choosing the optimal treatment plan.

Detailed Description

There is a lack of comprehensive trunk rehabilitation protocols within the field of multiple sclerosis. The existing studies mostly focus on core stability, pelvic muscles, or alternative methods. Consequently, the aim was to develop a protocol to investigate the potential positive effects of trunk rehabilitation. Drawing from our review of relevant literature, investigators in this study have developed a trunk training protocol that focuses on multiplanar movements carried out on unstable surfaces and additionally, incorporated dual-task training (DT), which adds a layer of complexity.

Conditions

Multiple Sclerosis; Trunk; Physical Therapy

Study Design

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

Study Groups

Trunk Group

Trunk exercises in multiplanar movement coupled with dual tasks on unstable surfaces.

Group Type: EXPERIMENTAL

Trunk Rehabilitation

Intervention Type: OTHER

Activating and strengthening the trunk muscles.

Core stability Group

Standard Core stability exercises carried in one plane on stable surfaces without dual tasks.

Group Type: ACTIVE_COMPARATOR

Core Stability

Intervention Type: OTHER

Standard core stability fucus on lower trunk.

Interventions

Trunk Rehabilitation

Activating and strengthening the trunk muscles.

Intervention Type: OTHER

Core Stability

Standard core stability fucus on lower trunk.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Clinically diagnosed with MS (McDonald's criteria)
• Able to walk 5 meters without assistance.
• No relapse in the past 2 months.

Exclusion Criteria

• Recent surgery.
• Cognitive or psychological dysfunctions.
• Diagnosis of any other systematic disease.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Shatha Mukhtar

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Majed M Albadi, PhD

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz University

Locations

King Abdulaziz University

Jeddah, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

Trunk Rehabilitation in MS

Identifier Type: -

Identifier Source: org_study_id