Trunk Rehabilitation Compared to Core Stability in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06447571
• Other study ID #: Trunk Rehabilitation in MS
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Physical Therapy
• Sclerosis

Intervention

Other:
• Trunk Rehabilitation
Activating and strengthening the trunk muscles.
• Core Stability
Standard core stability fucus on lower trunk.

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz University	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Berg Balance Scale (BBS)	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.
Secondary	Timed Up and Go (TUG)	used to evaluate functional mobility.	Baseline, 6 weeks, 1 month follow up.
Secondary	Modified Falls Efficacy Scale (MFES)	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.
Secondary	Modified Fatigue Impact Scale (MFIS)	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.
Secondary	Reintegration to Normal Living Index (RNLI)	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.