Trunk Rehabilitation Compared to Core Stability in Patients With Multiple Sclerosis

June 2, 2024 updated by: Shatha Mukhtar, King Abdulaziz University

The Effect of Trunk Rehabilitation Compared to Core Stability on Balance, Gait, Falls and Community Mobility in Patients With Multiple Sclerosis

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jeddah, Saudi Arabia, 21589
        • King Abdulaziz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trunk Group
Trunk exercises in multiplanar movement coupled with dual tasks on unstable surfaces.
Other: Trunk Rehabilitation
Activating and strengthening the trunk muscles.
Active Comparator: Core stability Group
Standard Core stability exercises carried in one plane on stable surfaces without dual tasks.
Other: Core Stability
Standard core stability fucus on lower trunk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trunk Impairment Scale (TIS)
Time Frame: Baseline, 6 weeks, 1 month follow up.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS)
Time Frame: Baseline, 6 weeks, 1 month follow up.
standardized assessment tool utilized to objectively evaluate an individual's ability to maintain balance during specific tasks. The total scores range between 0 for a minimal performance to 56 for a maximum performance.
Baseline, 6 weeks, 1 month follow up.
Timed Up and Go (TUG)
Time Frame: Baseline, 6 weeks, 1 month follow up.
used to evaluate functional mobility.
Baseline, 6 weeks, 1 month follow up.
Modified Falls Efficacy Scale (MFES)
Time Frame: Baseline, 6 weeks, 1 month follow up.
modified and expanded version of the Falls Efficacy Scale (FES), which assesses the fear of falling. The total scores range between 0 reflecting less confidence and more fear of falling to 140 for more confidence and less fear of falling.
Baseline, 6 weeks, 1 month follow up.
Modified Fatigue Impact Scale (MFIS)
Time Frame: Baseline, 6 weeks, 1 month follow up.
evaluates the effects of fatigue on cognitive, psychosocial, and physical functioning. The total scores range from 0 reflecting less impact of fatigue to 84 for greater impact of fatigue.
Baseline, 6 weeks, 1 month follow up.
Reintegration to Normal Living Index (RNLI)
Time Frame: Baseline, 6 weeks, 1 month follow up.
to assess community mobility. focus on measuring the extent of reintegration into regular social activities among individuals affected by disease. Scores range from 0 to 110, a lower score indicates minimal integration, and higher scores indicate better integration. A total score out of 110 points is proportionally converted to create a score out of 100.
Baseline, 6 weeks, 1 month follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Investigators

  • Principal Investigator: Majed M Albadi, PhD, King Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

June 2, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 2, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Trunk Rehabilitation in MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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