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Trunk Rehabilitation Compared to Core Stability in Patients With Multiple Sclerosis

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06447571
Enrollment
40
Registered
2024-06-07
Start date
2023-10-01
Completion date
2024-12-31
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Physical Therapy, Trunk

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.

Interventions

OTHERTrunk Rehabilitation

Activating and strengthening the trunk muscles.

OTHERCore Stability

Standard core stability fucus on lower trunk.

Sponsors

King Abdulaziz University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

First visit, a blinded physiotherapist will evaluate the patient, then they will be randomly divided into two groups using a computer-generated system.

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Trunk Impairment Scale (TIS)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.

Secondary

MeasureTime frameDescription
Berg Balance Scale (BBS)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.
Timed Up and Go (TUG)Baseline, 6 weeks, 1 month follow up.used to evaluate functional mobility.
Modified Falls Efficacy Scale (MFES)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.
Modified Fatigue Impact Scale (MFIS)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.
Reintegration to Normal Living Index (RNLI)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.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026