Multiple SclerosisNCT06511154
The Effect of Cognitive Exercise on Upper Extremity Functions, Balance and Cognitive Functions in Multiple Sclerosis
A study testing Cognitive Rehabilitation and Core-based Upper Extremity Exercises in people with Multiple Sclerosis, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
Multiple sclerosis (MS) is a chronic, progressive, demyelinating disease characterized by myelin sheath damage in the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults aged 20-40 years, especially in women. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cognitive Rehabilitation and Core-based Upper Extremity Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2024to 15 Jun 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18 and 65
- A definitive diagnosis of MS by a neurologist
- Having an Expanded Disability Status Scale (EDSS) score below 5.5
- No cognitive problems (Mini Mental Test score of 24 and above),
- Graduated from at least primary school
- No change in medical treatment in the last 6 months,
- Not having had an attack in the last 3 months and not using pulse steroid therapy
- Volunteering.
Who cannot join
- Having hearing and vision problems that prevent communication
- Having a neurological or psychiatric disease other than MS that causes cognitive impairment
- Pregnancy
- Oncological diseases
- Having other vestibular and orthopedic diseases that may affect balance
- Continue with a different exercise therapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Yıldırım Beyazıt University
Ankara, 06010
Emine İpek Halatcı, 05347708416, emnepek@gmail.com
About this study
Official title: The Effect of Cognitive Exercise in Addition to Physical Exercise on Upper Extremity Functions, Balance and Cognitive Functions in Individuals With Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, progressive, demyelinating disease characterized by myelin sheath damage in the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults aged 20-40 years, especially in women. Like physical impairments, cognitive impairments are a common clinical finding in individuals with MS, both in the early and late stages of the disease. Individuals with MS with cognitive impairment have more difficulty than those without cognitive impairment in participating in social and occupational activities, finding a job, working and performing routine household activities. It is also known that there is a high percentage of individuals with MS with upper extremity involvement in the early stages of the disease. Functional problems in the upper extremities lead to restriction of activity and participation in individuals with MS. Although it is stated that there is a high rate of upper extremity problems in individuals with MS, it is seen that they are not sufficiently understood and analyzed.
When the literature is examined; evidence-based studies examining the effect of cognitive exercise on motor functions in MS in addition to physical exercises are quite limited. In this context, the subject of this study is to examine the effect of cognitive rehabilitation on upper extremity functions, balance and cognitive functions in individuals with MS.
Read the detailed description
Cognitive rehabilitation is a set of therapeutic approaches that aim to increase functional capacity by examining the relationship between brain and behavior in many areas of cognition such as attention, memory, concentration, reasoning, problem solving, judgment, motor planning and awareness, and the first goal of treatment is to minimize the loss of acquired neuro-cognitive function. Although cognitive rehabilitation programs have been shown to significantly slow down cognitive decline in studies on MS, rehabilitation studies are still in their infancy. In addition, the content and intensity of the rehabilitation program required to provide an effective result have not been clarified. Evidence-based studies examining the effect of cognitive exercise in addition to physical exercise on motor function in MS are also very limited. There are some studies investigating cognitive rehabilitation alone or physical rehabilitation, but to our knowledge, there are no studies investigating the superiority of cognitive rehabilitation over a classical physiotherapy program consisting of core-based upper extremity exercises. Therefore, more original and new studies are needed. Our study is important in this sense. The aim of this study was to show the effect of cognitive rehabilitation on upper extremity functions, balance and cognitive functions when it is applied in addition to physical rehabilitation in order to develop coping strategies by slowing down cognitive losses in individuals with MS and to ensure regeneration if possible. With the findings obtained as a result of the study, it is aimed to increase the quality of life of MS patients by increasing and developing cognitive rehabilitation programs in MS patients.
- Conditions
- Multiple Sclerosis
- Being tested
- Cognitive Rehabilitation, Core-based Upper Extremity Exercises
- Keywords
- Multiple Sclerosis, Cognitive Rehabilitation, LOTCA
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RehabilitationOther
Also called Core-based Upper Extremity Exercises
Cognitive rehabilitation is a treatment method used to regain or improve cognitive abilities.For the cognitive rehabilitation program, the Daily Exercise Package of the Norosoft Program, which mainly includes exercises to improve attention, information processing speed, verbal and visual memory functions, will be applied.
Core-based Upper Extremity Exercises
Breathing exercises, Core based stabilization and mobilization exercises Upper extremity exercises Coordination ve proprioception exercises
Core-based Upper Extremity ExercisesOther
Breathing exercises, Core based stabilization and mobilization exercises Upper extremity exercises Coordination ve proprioception exercises
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients in this group are the group in which a physiotherapy program consisting of cognitive rehabilitation and core-based upper extremity exercises will be applied. Receives: Other: Cognitive Rehabilitation; Other: Core-based Upper Extremity Exercises |
| Control group | Active comparator | Patients in this group are the group in which a physiotherapy program consisting of core-based upper extremity exercises will be applied. Receives: Other: Core-based Upper Extremity Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive status
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) was developed to assess basic cognitive abilities. It is a standardized method used between 6-70 years of age. This scale consists of 6 main sections and 26 subtests including orientation, visual perception, spatial perception, motor praxis, visual motor organization and thinking ability. It takes approximately 30-45 minutes to administer.
Measured: Change from baseline at 8 weeks treatment program after.
Upper extremity
Manual Ability Measure-36: The scale includes 23 items with a wide range of difficulty that measure the functional level of patients.
Nine Hole Peg Test: Evaluates unilateral fine motor skills in the upper extremity. It requires the participants to first insert the nine sticks one by one into the nine holes and then remove them as quickly as possible against the clock.
Box and Block Test: It is used to measure hand gross skill performance.The patient is asked to transfer the maximum number of blocks, one at a time, from one compartment of a wooden box divided into two compartments to the other within 60 seconds.
Jebsen - Taylor Hand Function Test: It is an standardized test used to measure fine and gross motor functions of the hand by simulating daily life activities. It consists of 7 subtests: writing, simulated number spinning, lifting small objects, simulated feeding, stacking, moving large light and heavy objects.
Measured: Change from baseline at 8 weeks treatment program after.
Secondary outcomes (4)
Coordination
The Finger to Nose Test is a practical test commonly used to assess coordination. The patient moves his/her arm from the fully extended position to the bent position, touches his/her finger to his/her nose and opens his/her arm again. The patient performs this movement consecutively. Another common one is that the patient touches his/her index finger to the clinician's index finger and then touches his/her own nose, this movement is repeated many times while the clinician continuously changes the position of his/her finger.
Measured: Change from baseline at 8 weeks treatment program after.
Balance
Timed Up and Go Test: It is a method that evaluates the person's ability to move and requires both static and dynamic balance. In the test, the person is asked to get up from the chair, walk 3 meters at a safe and normal speed, turn, walk back and sit on the chair and the time is recorded in seconds. A shorter time indicates better balance and mobility. The starting position of the test is standardized.
Berg Balance Scale: clinically evaluates functional balance and consists of 14 items related to functional tasks. These activities are ranked from the easiest to the most difficult. The items of the scale include activities requiring both dynamic and static balance. For each item, the level of competence in the activity is indicated by 5 points (0-4), with 0 being "unable" and 4 being "independent and safe". The maximum score is 56 points, with higher scores indicating better balance.
Measured: Change from baseline at 8 weeks treatment program after.
Fatigue
Modified Fatigue Impact Scale: Will be used to measure fatigue. It is a modified version of the Fatigue Impact Scale based on items from interviews with MS patients about how fatigue affects their lives. It provides information about the effects of fatigue over the past four weeks in the physical (9 items), psychosocial (2 items) and cognitive (10 items) domains. The scale uses a 5-point Likert scale with 0 being 'Never' and 4 being 'Always'. An overall Modified Fatigue Impact Scale score of 38 or above is indicative of MS-related fatigue.
Measured: Change from baseline at 8 weeks treatment program after.
Position Sense
Position Sense: Shoulder position sense will be measured for position sense measurement. Acumar dual digital inclinometer (Acu360, Acumar, Lafayette, USA) will be used to assess shoulder position sense. Before starting the tests, the test will be taught to the individuals both verbally and with practice in order to minimize the error rate. Shoulder abduction and flexion will be calculated at 30° and 60ᵒ. For both movements, the shoulder will start in neutral rotation position. Individuals will first be made to perform passive movement. After 3 seconds in this position, the shoulder will be brought to the neutral position. Afterwards, the individual will be asked to actively move the shoulder to the desired angle and movement and hold this position for 3 seconds with their eyes closed and express it aloud. Measurements will be repeated in both limbs (non-dominant and dominant) and a rest period of 60 seconds will be allowed between trials.
Measured: Change from baseline at 8 weeks treatment program after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start13 May 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
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.
- 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
- Parallel Assingment dual parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Collaborators
- Gulhane Training and Research Hospital
- Responsible party
- Sponsor
- Investigators
- Emine İpek Halatcı, MSc, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511154
- Sponsor's protocol ID
- 21.03.2024/03-641
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Indivudual participant data will be available to the responsible researcher.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Exercise in Addition to Physical Exercise on Upper Extremity Functions, Balance and Cognitive Functions in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06511154
- Acronym / sponsor ID
- 21.03.2024/03-641
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Cognitive Rehabilitation, LOTCA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Collaborators
- Gulhane Training and Research Hospital
- Study start
- 13 May 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 19 Jul 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.
Multiple sclerosis (MS) is a chronic, progressive, demyelinating disease characterized by myelin sheath damage in the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults aged 20-40 years, especially in women. Like physical impairments, cognitive impairments are a common clinical finding in individuals with MS, both in the early and late stages of the disease. Individuals with MS with cognitive impairment have more difficulty than those without cognitive impairment in participating in social and occupational activities, finding a job, working and performing routine household activities. It is also known that there is a high percentage of individuals with MS with upper extremity involvement in the early stages of the disease. Functional problems in the upper extremities lead to restriction of activity and participation in individuals with MS. Although it is stated that there is a high rate of upper extremity problems in individuals with MS, it is seen that they are not sufficiently understood and analyzed.
When the literature is examined; evidence-based studies examining the effect of cognitive exercise on motor functions in MS in addition to physical exercises are quite limited. In this context, the subject of this study is to examine the effect of cognitive rehabilitation on upper extremity functions, balance and cognitive functions in individuals with MS.
Detailed description
Cognitive rehabilitation is a set of therapeutic approaches that aim to increase functional capacity by examining the relationship between brain and behavior in many areas of cognition such as attention, memory, concentration, reasoning, problem solving, judgment, motor planning and awareness, and the first goal of treatment is to minimize the loss of acquired neuro-cognitive function. Although cognitive rehabilitation programs have been shown to significantly slow down cognitive decline in studies on MS, rehabilitation studies are still in their infancy. In addition, the content and intensity of the rehabilitation program required to provide an effective result have not been clarified. Evidence-based studies examining the effect of cognitive exercise in addition to physical exercise on motor function in MS are also very limited. There are some studies investigating cognitive rehabilitation alone or physical rehabilitation, but to our knowledge, there are no studies investigating the superiority of cognitive rehabilitation over a classical physiotherapy program consisting of core-based upper extremity exercises. Therefore, more original and new studies are needed. Our study is important in this sense. The aim of this study was to show the effect of cognitive rehabilitation on upper extremity functions, balance and cognitive functions when it is applied in addition to physical rehabilitation in order to develop coping strategies by slowing down cognitive losses in individuals with MS and to ensure regeneration if possible. With the findings obtained as a result of the study, it is aimed to increase the quality of life of MS patients by increasing and developing cognitive rehabilitation programs in MS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assingment dual parallel group design
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Cognitive Rehabilitation, Other: Core-based Upper Extremity ExercisesPatients in this group are the group in which a physiotherapy program consisting of cognitive rehabilitation and core-based upper extremity exercises will be applied. |
| Control group | Active comparator | Other: Core-based Upper Extremity ExercisesPatients in this group are the group in which a physiotherapy program consisting of core-based upper extremity exercises will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being between the ages of 18 and 65
- A definitive diagnosis of MS by a neurologist
- Having an Expanded Disability Status Scale (EDSS) score below 5.5
- No cognitive problems (Mini Mental Test score of 24 and above),
- Graduated from at least primary school
Key exclusion criteria (6 listed)
- Having hearing and vision problems that prevent communication
- Having a neurological or psychiatric disease other than MS that causes cognitive impairment
- Pregnancy
- Oncological diseases
- Having other vestibular and orthopedic diseases that may affect balance
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 |
|---|---|---|
| Cognitive RehabilitationAlso: Core-based Upper Extremity ExercisesCognitive rehabilitation is a treatment method used to regain or improve cognitive abilities.For the cognitive rehabilitation program, the Daily Exercise Package of the Norosoft Program, which mainly includes exercises to improve attention, information processing speed, verbal and visual memory functions, will be applied. Core-based Upper Extremity Exercises Breathing exercises, Core based stabilization and mobilization exercises Upper extremity exercises Coordination ve proprioception exercises | Other | Treatment group |
| Core-based Upper Extremity ExercisesBreathing exercises, Core based stabilization and mobilization exercises Upper extremity exercises Coordination ve proprioception exercises | Other | Control group, Treatment group |
Primary outcome
Cognitive status
Time frame: Change from baseline at 8 weeks treatment program after.
Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) was developed to assess basic cognitive abilities. It is a standardized method used between 6-70 years of age. This scale consists of 6 main sections and 26 subtests including orientation, visual perception, spatial perception, motor praxis, visual motor organization and thinking ability. It takes approximately 30-45 minutes to administer.
Upper extremity
Time frame: Change from baseline at 8 weeks treatment program after.
Manual Ability Measure-36: The scale includes 23 items with a wide range of difficulty that measure the functional level of patients. Nine Hole Peg Test: Evaluates unilateral fine motor skills in the upper extremity. It requires the participants to first insert the nine sticks one by one into the nine holes and then remove them as quickly as possible against the clock. Box and Block Test: It is used to measure hand gross skill performance.The patient is asked to transfer the maximum number of blocks, one at a time, from one compartment of a wooden box divided into two compartments to the other within 60 seconds. Jebsen - Taylor Hand Function Test: It is an standardized test used to measure fine and gross motor functions of the hand by simulating daily life activities. It consists of 7 subtests: writing, simulated number spinning, lifting small objects, simulated feeding, stacking, moving large light and heavy objects.
4 secondary outcomes
Coordination
Time frame: Change from baseline at 8 weeks treatment program after.
Balance
Time frame: Change from baseline at 8 weeks treatment program after.
Fatigue
Time frame: Change from baseline at 8 weeks treatment program after.
Position Sense
Time frame: Change from baseline at 8 weeks treatment program after.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: No. Indivudual participant data will be available to the responsible researcher.
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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.
Emine İpek Halatcı, MSc principal investigator
Ankara Yildirim Beyazıt 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 Cognitive Rehabilitation and Core-based Upper Extremity Exercises in people with Multiple Sclerosis, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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 8 inclusion and 6 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 19 Jul 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 Turkey (Türkiye). 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?
Contact Emine İpek Halatcı, MSc (05347708416, emnepek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive status (time frame: Change from baseline at 8 weeks treatment program after.). 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 19 Jul 2024.