Multiple SclerosisMSNCT05993819
Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training in Patients With Multiple Sclerosis
A study testing pilates based core stability training and congnitive therapy and Pilates based core stability training in people with Multiple Sclerosis, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate the effect of adding cognitive behaviour therapy to supervised Pilates-based core stability training on balance, walking, fatigue and function in patients with multiple sclerosis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- pilates based core stability training and congnitive therapy and Pilates based core stability training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2023to 28 Feb 2026
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A score of 3.5 or less on the Expanded Disability Status Scale (EDSS) because individuals with an EDSS score greater than 3.5 need more assistance, being less independent.
- Age over 18 years
- All definite multiple sclerosis patients diagnosed as MS according to revised McDonald criteria 2017
- Both males and females were included
Who cannot join
- -Individuals who had orthopedic, neurologic, and psychological problems that accompanied MS that might affect the treatment results-
- serious cognitive problems; performed regular exercise; were involved in another physiotherapy and rehabilitation program related to MS(Kurtzke, 1993)
- Pregnant were not included.
- Individuals who had an exacerbation during the treatment period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training on Balance and Walking in Patients With Multiple Sclerosis
To investigate the effect of adding cognitive behaviour therapy to supervised Pilates-based core stability training on balance, walking, fatigue and function in patients with multiple sclerosis
Read the detailed description
Multiple sclerosis (MS) is characterized by widespread demyelinating lesions and neurodegeneration in the central nervous system, leading to muscle weakness and compromised sensory-motor integration. Muscle weakness predominantly seen in lower extremities and decreased postural control deteriorate physical performance and gait function. Also , respiratory dysfunction and fatigue has been occurred. Optimal trunk control is provided by the somatosensory, motor, and musculoskeletal integrity, which is mostly damaged in MS. Core stability, is defined as the ability to control the position and movement of the trunk on the pelvis to allow optimum power and movement generation, transfer, and control in other segments. A decrease in core stability affects both trunk control and the quality of limb movements due to the kinetic chain in the body. Pilates-based core stability training (PBCST) is a controlled form of exercise used to improve the stabilization of the trunk muscles. The purpose of PBCST is to train the core muscles more effectively by using the basic principles of Pilates integrated into core stabilization exercises and the activation effect of breathing on deep muscles. Transversus abdominis (TrA) activation is crucial in this training. TrA is activated by a feed-forward mechanism of neuromuscular control before sudden spinal loads or limb movements and provides postural adaptation. Thus, effective TrA activation contributes to both distal mobility and postural control by increasing trunk stability (Freeman el al., 2012). We have recently developed a cognitive behavior therapy to explain MS fatigue that integrates the findings across biological and psychosocial research. This model proposes that primary disease factors trigger the initial symptom of fatigue in MS, and the fatigue is perpetuated or worsened depending . fifty patients with MS will be assigned randomly into two equal group; first one will receive cognitive behavioral therapy and pilates and the other will receive pilates only for eight weeks
- Conditions
- Multiple Sclerosis
- Being tested
- pilates based core stability training and congnitive therapy, Pilates based core stability training
- Keywords
- cognitive behaviour therapy, Pilates exercise, palance, walking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pilates based core stability training and congnitive therapyOther
Exercises were structured in different conditions such as supine, side-lying, prone, quadruped, sitting, and standing positions. The various variations of each exercise were created so that the easier or more difficult versions of the exercises were selected according to the level of the patients, basically in the same training plan for all.the patients also will receive cognitive behavioural therapy.The CBT manual was written specifically for this trial. The sessions were collaborative in style, and the therapist used Socratic questioning wherever possible. The main aim was to challenge any behavioral, cognitive, emotional and external factors that may be contributing to MS fatigue.
Pilates based core stability trainingOther
Exercises were structured in different conditions such as supine, side-lying, prone, quadruped, sitting, and standing positions. The various variations of each exercise were created so that the easier or more difficult versions of the exercises were selected according to the level of the patients, basically in the same training plan for all. The exercises were gradually made more difficult to increase the stabilization of the trunk by gradually reducing the support surface, increasing the extremity loading, and adding various materials.Exercises were progressed every 2 weeks in both groups and were performed with 10 repetitions for the first 4 weeks and 15 repetitions for the next 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| pilates based core stability training and congnitive therapy | Experimental | the patients will receive pilates and cognitive therapy three times a week for eight weeks Receives: Other: pilates based core stability training and congnitive therapy |
| Pilates based core stability training | Active comparator | the patients will receive pilates three times a week for eight weeks Receives: Other: Pilates based core stability training |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking assessment
walking will be assessed by walkway device
Measured: up to eight weeks
balance
balance will be assessed by biodex balance device
Measured: up to eight weeks
Secondary outcomes (2)
fatigue
fatigue severity scale will be used for assessment of fatigue. The FSS is a self-reported questionnaire that is simple and easy to use. It consists of 9 statements that rate the severity of the patient's fatigue symptoms in terms of how these symptoms affect motivation, exercise, physical function, and activities of daily living. Reflecting on their condition over the past week, patients score each item from 1 to 7, based on the extent, to which they agree or disagree with each statement (1 = strong disagreement, 7 = strong agreement).
Measured: up to eight weeks
life disability
short form 36 will be used for assessment the quality of life in eight domains. score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Measured: up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start15 Aug 2023
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- pilates and cognitive behavioral therapy
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993819
- Sponsor's protocol ID
- p.t.REC/012/004535
- Acronym
- MS
- Status last verified
- Mar 2026
- First submitted
- 7 Aug 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adding Cognitive Behaviour Therapy to Supervised Pilates-based Core Stability Training on Balance and Walking in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05993819
- Acronym / sponsor ID
- MS / p.t.REC/012/004535
- Conditions
- Multiple Sclerosis
- Keywords
- cognitive behaviour therapy, Pilates exercise, palance, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 15 Aug 2023 (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.
To investigate the effect of adding cognitive behaviour therapy to supervised Pilates-based core stability training on balance, walking, fatigue and function in patients with multiple sclerosis
Detailed description
Multiple sclerosis (MS) is characterized by widespread demyelinating lesions and neurodegeneration in the central nervous system, leading to muscle weakness and compromised sensory-motor integration. Muscle weakness predominantly seen in lower extremities and decreased postural control deteriorate physical performance and gait function. Also , respiratory dysfunction and fatigue has been occurred. Optimal trunk control is provided by the somatosensory, motor, and musculoskeletal integrity, which is mostly damaged in MS. Core stability, is defined as the ability to control the position and movement of the trunk on the pelvis to allow optimum power and movement generation, transfer, and control in other segments. A decrease in core stability affects both trunk control and the quality of limb movements due to the kinetic chain in the body. Pilates-based core stability training (PBCST) is a controlled form of exercise used to improve the stabilization of the trunk muscles. The purpose of PBCST is to train the core muscles more effectively by using the basic principles of Pilates integrated into core stabilization exercises and the activation effect of breathing on deep muscles. Transversus abdominis (TrA) activation is crucial in this training. TrA is activated by a feed-forward mechanism of neuromuscular control before sudden spinal loads or limb movements and provides postural adaptation. Thus, effective TrA activation contributes to both distal mobility and postural control by increasing trunk stability (Freeman el al., 2012). We have recently developed a cognitive behavior therapy to explain MS fatigue that integrates the findings across biological and psychosocial research. This model proposes that primary disease factors trigger the initial symptom of fatigue in MS, and the fatigue is perpetuated or worsened depending . fifty patients with MS will be assigned randomly into two equal group; first one will receive cognitive behavioral therapy and pilates and the other will receive pilates only for eight weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- pilates and cognitive behavioral therapy
| Arm | Type | Receives |
|---|---|---|
| pilates based core stability training and congnitive therapy | Experimental | Other: pilates based core stability training and congnitive therapythe patients will receive pilates and cognitive therapy three times a week for eight weeks |
| Pilates based core stability training | Active comparator | Other: Pilates based core stability trainingthe patients will receive pilates three times a week for eight weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A score of 3.5 or less on the Expanded Disability Status Scale (EDSS) because individuals with an EDSS score greater than 3.5 need more assistance, being less independent.
- Age over 18 years
- All definite multiple sclerosis patients diagnosed as MS according to revised McDonald criteria 2017
- Both males and females were included
Key exclusion criteria (4 listed)
- -Individuals who had orthopedic, neurologic, and psychological problems that accompanied MS that might affect the treatment results-
- serious cognitive problems; performed regular exercise; were involved in another physiotherapy and rehabilitation program related to MS(Kurtzke, 1993)
- Pregnant were not included.
- Individuals who had an exacerbation during the treatment period
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 |
|---|---|---|
| pilates based core stability training and congnitive therapyExercises were structured in different conditions such as supine, side-lying, prone, quadruped, sitting, and standing positions. The various variations of each exercise were created so that the easier or more difficult versions of the exercises were selected according to the level of the patients, basically in the same training plan for all.the patients also will receive cognitive behavioural therapy.The CBT manual was written specifically for this trial. The sessions were collaborative in style, and the therapist used Socratic questioning wherever possible. The main aim was to challenge any behavioral, cognitive, emotional and external factors that may be contributing to MS fatigue. | Other | pilates based core stability training and congnitive therapy |
| Pilates based core stability trainingExercises were structured in different conditions such as supine, side-lying, prone, quadruped, sitting, and standing positions. The various variations of each exercise were created so that the easier or more difficult versions of the exercises were selected according to the level of the patients, basically in the same training plan for all. The exercises were gradually made more difficult to increase the stabilization of the trunk by gradually reducing the support surface, increasing the extremity loading, and adding various materials.Exercises were progressed every 2 weeks in both groups and were performed with 10 repetitions for the first 4 weeks and 15 repetitions for the next 4 weeks. | Other | Pilates based core stability training |
Primary outcome
walking assessment
Time frame: up to eight weeks
walking will be assessed by walkway device
balance
Time frame: up to eight weeks
balance will be assessed by biodex balance device
2 secondary outcomes
fatigue
Time frame: up to eight weeks
life disability
Time frame: up to eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pilates based core stability training and congnitive therapy and Pilates based core stability training in people with Multiple Sclerosis, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 5 Mar 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
walking assessment (time frame: up to eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2026.