Clinical trial NCT06447571: Trunk Rehabilitation Compared to Core Stability in Patients With Multiple Sclerosis
Official title: The Effect of Trunk Rehabilitation Compared to Core Stability on Balance, Gait, Falls and Community Mobility in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Trunk
Physical Therapy
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Trunk Impairment Scale (TIS)
timeFrame: Baseline, 6 weeks, 1 month follow up.
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Baseline, 6 weeks, 1 month follow up.
measure: Timed Up and Go (TUG)
timeFrame: Baseline, 6 weeks, 1 month follow up.
measure: Modified Falls Efficacy Scale (MFES)
timeFrame: Baseline, 6 weeks, 1 month follow up.
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Baseline, 6 weeks, 1 month follow up.
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: Baseline, 6 weeks, 1 month follow up.
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
Study officials:
affiliation: King Abdulaziz University
name: Majed M Albadi, PhD
role: PRINCIPAL_INVESTIGATOR
References: