The Effect of Trunk Rehabilitation Compared to Core Stability on Balance, Gait, Falls and Community Mobility in Patients With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- King Abdulaziz University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Trunk Impairment Scale (TIS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Core stability Group
Standard Core stability exercises carried in one plane on stable surfaces without dual tasks.
Intervention: Core Stability (Other)
Trunk Group
Trunk exercises in multiplanar movement coupled with dual tasks on unstable surfaces.
Intervention: Trunk Rehabilitation (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Reintegration to Normal Living Index (RNLI)(Baseline, 6 weeks, 1 month follow up.)
- Berg Balance Scale (BBS)(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.)
- Timed Up and Go (TUG)(Baseline, 6 weeks, 1 month follow up.)
Investigators
Shatha Mukhtar
Principle Investigator
King Abdulaziz University