Multiple SclerosisNCT06447571
Trunk Rehabilitation Compared to Core Stability in Patients With Multiple Sclerosis
A study testing Trunk Rehabilitation and Core Stability in people with Multiple Sclerosis and Trunk, run by King Abdulaziz University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Trunk, Physical Therapy
- What is being tested?
- Trunk Rehabilitation and Core Stability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Oct 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically diagnosed with MS (McDonald's criteria)
- Able to walk 5 meters without assistance.
- No relapse in the past 2 months.
Who cannot join
- Recent surgery.
- Cognitive or psychological dysfunctions.
- Diagnosis of any other systematic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Trunk, Physical Therapy
- Being tested
- Trunk Rehabilitation, Core Stability
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk RehabilitationOther
Activating and strengthening the trunk muscles.
Core StabilityOther
Standard core stability fucus on lower trunk.
| Study group | Role | What they receive |
|---|---|---|
| Trunk Group | Experimental | Trunk exercises in multiplanar movement coupled with dual tasks on unstable surfaces. Receives: Other: Trunk Rehabilitation |
| Core stability Group | Active comparator | Standard Core stability exercises carried in one plane on stable surfaces without dual tasks. Receives: Other: Core Stability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 1 month follow up.
Secondary outcomes (5)
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.
Measured: Baseline, 6 weeks, 1 month follow up.
Timed Up and Go (TUG)
used to evaluate functional mobility.
Measured: Baseline, 6 weeks, 1 month follow up.
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.
Measured: Baseline, 6 weeks, 1 month follow up.
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.
Measured: Baseline, 6 weeks, 1 month follow up.
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.
Measured: Baseline, 6 weeks, 1 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Oct 2023
- Primary completion1 Jun 2024
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shatha Mukhtar, King Abdulaziz University
- Investigators
- Majed M Albadi, PhD, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447571
- Sponsor's protocol ID
- Trunk Rehabilitation in MS
- Status last verified
- Jun 2024
- First submitted
- 17 Apr 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mukhtar S, Aljohani G, Bakkar M, Almutairi N, Mazi A, Alsweed L, Albadi M, Aldhabi R, Khan F. The effects of trunk rehabilitation on balance, gait, falls, and community mobility in patients with multiple sclerosis: A single-blind randomized controlled trial. Mult Scler Relat Disord. 2026 Feb;106:106929. doi: 10.1016/j.msard.2025.106929. Epub 2025 Dec 13.
PubMed 41421012
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trunk Rehabilitation Compared to Core Stability on Balance, Gait, Falls and Community Mobility in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06447571
- Acronym / sponsor ID
- Trunk Rehabilitation in MS
- Conditions
- Multiple Sclerosis, Trunk, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trunk Group | Experimental | Other: Trunk RehabilitationTrunk exercises in multiplanar movement coupled with dual tasks on unstable surfaces. |
| Core stability Group | Active comparator | Other: Core StabilityStandard Core stability exercises carried in one plane on stable surfaces without dual tasks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinically diagnosed with MS (McDonald's criteria)
- Able to walk 5 meters without assistance.
- No relapse in the past 2 months.
Key exclusion criteria (3 listed)
- Recent surgery.
- Cognitive or psychological dysfunctions.
- Diagnosis of any other systematic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trunk RehabilitationActivating and strengthening the trunk muscles. | Other | Trunk Group |
| Core StabilityStandard core stability fucus on lower trunk. | Other | Core stability Group |
Primary outcome
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.
5 secondary outcomes
Berg Balance Scale (BBS)
Time frame: Baseline, 6 weeks, 1 month follow up.
Timed Up and Go (TUG)
Time frame: Baseline, 6 weeks, 1 month follow up.
Modified Falls Efficacy Scale (MFES)
Time frame: Baseline, 6 weeks, 1 month follow up.
Modified Fatigue Impact Scale (MFIS)
Time frame: Baseline, 6 weeks, 1 month follow up.
Reintegration to Normal Living Index (RNLI)
Time frame: Baseline, 6 weeks, 1 month follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Derived from this study: PubMed 41421012Mukhtar S, Aljohani G, Bakkar M, Almutairi N, Mazi A, Alsweed L, Albadi M, Aldhabi R, Khan F. The effects of trunk rehabilitation on balance, gait, falls, and community mobility in patients with multiple sclerosis: A single-blind randomized controlled trial. Mult Scler Relat Disord. 2026 Feb;106:106929. doi: 10.1016/j.msard.2025.106929. Epub 2025 Dec 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Majed M Albadi, PhD principal investigator
King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trunk Rehabilitation and Core Stability in people with Multiple Sclerosis and Trunk, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Impairment Scale (TIS) (time frame: Baseline, 6 weeks, 1 month follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06447571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.