Trunk Rehabilitation Compared to Core Stability in Patients With Multiple Sclerosis

NCT06447571 | Active Not Recruiting

• 1 other identifier: Trunk Rehabilitation in MS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Trunk; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Trunk Impairment Scale (TIS)

  evaluates motor impairment of the trunk by assessing static and dynamic sitting balance and coordination of trunk movement. The total scores range between 0 for a minimal performance to 23 for a maximum performance.

  Baseline, 6 weeks, 1 month follow up.

Secondary Outcomes (5)

• Berg Balance Scale (BBS)

  Baseline, 6 weeks, 1 month follow up.

• Timed Up and Go (TUG)

  Baseline, 6 weeks, 1 month follow up.

• Modified Falls Efficacy Scale (MFES)

  Baseline, 6 weeks, 1 month follow up.

• Modified Fatigue Impact Scale (MFIS)

  Baseline, 6 weeks, 1 month follow up.

• Reintegration to Normal Living Index (RNLI)

  Baseline, 6 weeks, 1 month follow up.

Study Arms (2)

Trunk Group

EXPERIMENTAL

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

Other: Trunk Rehabilitation

Core stability Group

ACTIVE COMPARATOR

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

Other: Core Stability

Interventions

Trunk Rehabilitation OTHER

Activating and strengthening the trunk muscles.

Trunk Group

Core Stability OTHER

Standard core stability fucus on lower trunk.

Core stability Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, 21589, Saudi Arabia

Location

Related Publications (1)

• Mukhtar S, Aljohani G, Bakkar M, Almutairi N, Mazi A, Alsweed L, Albadi M, Aldhabi R, Khan F. The effects of trunk rehabilitation on balance, gait, falls, and community mobility in patients with multiple sclerosis: A single-blind randomized controlled trial. Mult Scler Relat Disord. 2025 Dec 13;106:106929. doi: 10.1016/j.msard.2025.106929. Online ahead of print.

  PMID: 41421012 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Core Stability

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Postural Balance; Proprioception; Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sensation; Nervous System Physiological Phenomena

Study Officials

• Majed M Albadi, PhD

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: First visit, a blinded physiotherapist will evaluate the patient, then they will be randomly divided into two groups using a computer-generated system.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: June 7, 2024
• Study Start: October 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

SA (1)