Multiple SclerosisNCT07899411
Evaluation of the Effect of Mental Imagery Training Combined With Modified Constraint-Induced Movement Therapy in Individuals With Multiple Sclerosis
A study testing odified Constraint-Induced Movement Therapy + Mental Imagery Training and Modified Constraint-Induced Movement Therapy in people with Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of mental imagery training combined with modified constraint-induced movement therapy in individuals with multiple sclerosis. Participants will be randomly assigned to an intervention group receiving mental imagery training combined with modified constraint-induced movement… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- odified Constraint-Induced Movement Therapy + Mental Imagery Training and Modified Constraint-Induced Movement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A definitive diagnosis of multiple sclerosis (MS) by a neurologist according to the McDonald criteria.
- Presence of an asymmetric upper extremity motor deficit attributable to MS, determined by calculating the difference in performance time between the extremities using the Nine-Hole Peg Test (9HPT).
- Marked non-use of the more affected upper extremity during activities of daily living (Motor Activity Log average item score ≤2.5).
- Ability to perform at least 20° of wrist extension starting from full wrist flexion, at least 10° of thumb extension or abduction, and at least 10° of extension at the metacarpophalangeal and interphalangeal joints of the other fingers.
- No relapse within the previous 3 months.
- Right-hand dominance.
- Basic computer skills, including turning the computer on and off, opening and closing the relevant program, and adjusting the volume.
Who cannot join
- A score greater than 1 on the Modified Ashworth Scale (MAS >1) in at least one upper extremity muscle.
- Upper extremity pain, defined as a score greater than 4 on the Visual Analog Scale (VAS).
- A score below 24 on the Mini-Mental State Examination (MMSE).
- Severe hearing and/or speech impairment.
- Presence of an additional neurological, musculoskeletal, or other condition that may affect upper extremity motor function.
- Previous receipt of Constraint-Induced Movement Therapy (CIMT).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kocaeli University Hospital - Department of Neurology
Köseköy, Kocaeli, 41000
Gizem Şekercan, PhD Student, +90 553 416 81 87, gizemsekercan@gmail.com
Yeliz Şekercan
About this study
This study aims to investigate the effects of mental imagery training combined with modified constraint-induced movement therapy in individuals with multiple sclerosis. Participants will be randomly assigned to an intervention group receiving mental imagery training combined with modified constraint-induced movement therapy or a control group receiving modified constraint-induced movement therapy alone.
- Conditions
- Multiple Sclerosis
- Being tested
- odified Constraint-Induced Movement Therapy + Mental Imagery Training, Modified Constraint-Induced Movement Therapy
- Keywords
- multiple sclerosis, Modified Constraint-Induced Movement Therapy, Mental Imagery
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
odified Constraint-Induced Movement Therapy + Mental Imagery TrainingBehavioural
Also called Experimental Group
Experimental Group (mCIMT + MI)
mCIMT: Modified Constraint-Induced Movement Therapy will be administered throughout the treatment period for 90 minutes per session, 5 days per week, for 3 weeks, for a total of 22.5 hours. In addition, a 30-minute transfer package will be administered 5 days per week for 3 weeks, for a total of 7.5 hours.
MI: Mental Imagery Training will be administered throughout the treatment period for 20 minutes per session, 5 days per week, for 3 weeks, for a total of 5 hours.
A total of 35 hours of intervention will be administered.
Modified Constraint-Induced Movement TherapyBehavioural
Also called Active Comparator
Control Group (mCIMT)
Modified Constraint-Induced Movement Therapy will be administered throughout the treatment period for 90 minutes per session, 5 days per week, for 3 weeks, for a total of 22.5 hours. In addition, a 30-minute transfer package will be administered 5 days per week for 3 weeks, for a total of 7.5 hours. A total of 30 hours of intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Mental Imagery + mCIMT Group | Experimental | Participants will receive modified constraint-induced movement therapy combined with mental imagery training. Receives: Behavioral: odified Constraint-Induced Movement Therapy + Mental Imagery Training |
| mCIMT Group | Active comparator | Participants will receive modified constraint-induced movement therapy alone. Receives: Behavioral: Modified Constraint-Induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Fonksiyon Testi (WMFT)
Assessment of upper extremity motor function using the Wolf Motor Function Test (WMFT). The Functional Ability Scale (FAS) of the Wolf Motor Function Test (WMFT) assesses upper extremity functional performance during 15 tasks. Each task is scored on a 6-point scale ranging from 0 to 5, where 0 indicates that the affected upper extremity was not used during the task and 5 indicates normal movement. Higher scores indicate better functional ability.
Measured: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.
Secondary outcomes (7)
Nine-Hole Peg Test (9HPT)
Assessment of fine manual dexterity and upper extremity function. The Nine-Hole Peg Test (9HPT) assesses manual dexterity. The participant is instructed to place nine pegs into nine holes and remove them as quickly as possible. The time required to complete the task is recorded in seconds. Shorter completion times indicate better manual dexterity and upper extremity function. A completion time of less than 18 seconds indicates good fine motor dexterity.
Measured: At baseline, immediately after the 3-week intervention
Lafayette Hand Grip Test
Assessment of hand grip strength. The assessment will be performed with the participant in a seated position, with the shoulder adducted, the elbow flexed to 90 degrees and positioned close to the trunk, and the forearm and wrist in a neutral position.
Measured: At baseline, immediately after the 3-week intervention
Nelson Visual Hand Reaction Time Test (NVHRT)
Assessment of visual hand reaction time. Participants will be seated with their forearms and hands resting on a table. The thumb and index finger will be positioned 8-10 cm above the table, with their upper surfaces parallel to each other. Participants will be instructed to focus on the midpoint of a ruler held between the thumb and index finger. When the ruler is released, the numerical value corresponding to the point at which the participant catches it will be recorded. Reaction time will be calculated using the formula: Reaction time (s) = √(2 × distance (cm) / 980 cm/s²), where distance represents the distance the ruler falls before being caught and 980 cm/s² is the acceleration due to gravity. The test will be repeated three times, and the mean reaction time will be calculated.
Measured: At baseline, immediately after the 3-week intervention
Modified Fatigue Impact Scale (MFIS)
Assessment of the impact of fatigue on daily functioning. The Modified Fatigue Impact Scale (MFIS) consists of 21 items divided into three subscales: physical (9 items), cognitive (10 items), and psychosocial (2 items). The total score ranges from 0 to 84, with higher scores indicating a greater impact of fatigue on daily functioning and a worse outcome.
Measured: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.
Functional Independence Measure (FIM)
Assessment of functional independence. The Functional Independence Measure (FIM) is an 18-item scale designed to assess an individual's level of independence in basic activities of daily living, including physical and cognitive activities. The scale consists of two domains: the motor domain, comprising self-care (6 items), sphincter control (2 items), transfers/mobility (3 items), and locomotion (2 items); and the cognitive domain, comprising communication (2 items) and social cognition (3 items). Each item is scored on a 7-point scale ranging from 1 to 7, with higher scores indicating greater independence and a better functional outcome. The total score ranges from 18 to 126.
Measured: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.
Motor Activity Log-28 (MAL-28)
Assessment of the amount and quality of use of the affected upper extremity in daily activities. The Motor Activity Log-28 (MAL-28) is a questionnaire used to assess the use of the more affected upper extremity in individuals following stroke. It consists of two subscales: the Amount of Use (AOU) scale, which assesses how frequently the more affected upper extremity is used in daily activities, and the Quality of Movement (QOM) scale, which assesses the quality of movement during these activities. Both subscales use a 6-point rating scale ranging from 0 to 5. Higher scores indicate greater use of the more affected upper extremity and better movement quality. The 28-item version has demonstrated validity and reliability.
Measured: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.
Treatment Satisfaction Measured Using the Visual Analogue Scale (VAS)
Treatment satisfaction will be assessed using a Visual Analogue Scale (VAS) immediately after completion of the 3-week intervention. Participants will rate their overall satisfaction with the intervention on a scale ranging from 0 to 10, where 0 indicates no satisfaction and 10 indicates the highest possible satisfaction. Higher scores indicate greater satisfaction with the intervention.
Measured: Immediately after the 3-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (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.
- More trials run by Hacettepe 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
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Şekercan, Hacettepe University
- Investigators
- Yeliz Salcı, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899411
- Sponsor's protocol ID
- FTR/EK26/103
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Data will be used solely for the purposes of the present study and will be managed in accordance with applicable ethical and data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Mental Imagery Training Combined With Modified Constraint-Induced Movement Therapy in Individuals With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07899411
- Acronym / sponsor ID
- FTR/EK26/103
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, Modified Constraint-Induced Movement Therapy, Mental Imagery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Oct 2026 (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.
This study aims to investigate the effects of mental imagery training combined with modified constraint-induced movement therapy in individuals with multiple sclerosis. Participants will be randomly assigned to an intervention group receiving mental imagery training combined with modified constraint-induced movement therapy or a control group receiving modified constraint-induced movement therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Imagery + mCIMT Group | Experimental | Behavioral: odified Constraint-Induced Movement Therapy + Mental Imagery TrainingParticipants will receive modified constraint-induced movement therapy combined with mental imagery training. |
| mCIMT Group | Active comparator | Behavioral: Modified Constraint-Induced Movement TherapyParticipants will receive modified constraint-induced movement therapy alone. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- A definitive diagnosis of multiple sclerosis (MS) by a neurologist according to the McDonald criteria.
- Presence of an asymmetric upper extremity motor deficit attributable to MS, determined by calculating the difference in performance time between the extremities using the Nine-Hole Peg Test (9HPT).
- Marked non-use of the more affected upper extremity during activities of daily living (Motor Activity Log average item score ≤2.5).
- Ability to perform at least 20° of wrist extension starting from full wrist flexion, at least 10° of thumb extension or abduction, and at least 10° of extension at the metacarpophalangeal and interphalangeal joints of the other fingers.
- No relapse within the previous 3 months.
Key exclusion criteria (6 listed)
- A score greater than 1 on the Modified Ashworth Scale (MAS >1) in at least one upper extremity muscle.
- Upper extremity pain, defined as a score greater than 4 on the Visual Analog Scale (VAS).
- A score below 24 on the Mini-Mental State Examination (MMSE).
- Severe hearing and/or speech impairment.
- Presence of an additional neurological, musculoskeletal, or other condition that may affect upper extremity motor function.
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 |
|---|---|---|
| odified Constraint-Induced Movement Therapy + Mental Imagery TrainingAlso: Experimental GroupExperimental Group (mCIMT + MI) mCIMT: Modified Constraint-Induced Movement Therapy will be administered throughout the treatment period for 90 minutes per session, 5 days per week, for 3 weeks, for a total of 22.5 hours. In addition, a 30-minute transfer package will be administered 5 days per week for 3 weeks, for a total of 7.5 hours. MI: Mental Imagery Training will be administered throughout the treatment period for 20 minutes per session, 5 days per week, for 3 weeks, for a total of 5 hours. A total of 35 hours of intervention will be administered. | Behavioural | Mental Imagery + mCIMT Group |
| Modified Constraint-Induced Movement TherapyAlso: Active ComparatorControl Group (mCIMT) Modified Constraint-Induced Movement Therapy will be administered throughout the treatment period for 90 minutes per session, 5 days per week, for 3 weeks, for a total of 22.5 hours. In addition, a 30-minute transfer package will be administered 5 days per week for 3 weeks, for a total of 7.5 hours. A total of 30 hours of intervention will be administered. | Behavioural | mCIMT Group |
Primary outcome
Wolf Motor Fonksiyon Testi (WMFT)
Time frame: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.
Assessment of upper extremity motor function using the Wolf Motor Function Test (WMFT). The Functional Ability Scale (FAS) of the Wolf Motor Function Test (WMFT) assesses upper extremity functional performance during 15 tasks. Each task is scored on a 6-point scale ranging from 0 to 5, where 0 indicates that the affected upper extremity was not used during the task and 5 indicates normal movement. Higher scores indicate better functional ability.
7 secondary outcomes
Nine-Hole Peg Test (9HPT)
Time frame: At baseline, immediately after the 3-week intervention
Lafayette Hand Grip Test
Time frame: At baseline, immediately after the 3-week intervention
Nelson Visual Hand Reaction Time Test (NVHRT)
Time frame: At baseline, immediately after the 3-week intervention
Modified Fatigue Impact Scale (MFIS)
Time frame: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.
Functional Independence Measure (FIM)
Time frame: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.
Motor Activity Log-28 (MAL-28)
Time frame: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.
Treatment Satisfaction Measured Using the Visual Analogue Scale (VAS)
Time frame: Immediately after the 3-week intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Data will be used solely for the purposes of the present study and will be managed in accordance with applicable ethical and data protection requirements.
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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.
Yeliz Salcı principal investigator
Hacettepe 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 odified Constraint-Induced Movement Therapy + Mental Imagery Training and Modified Constraint-Induced Movement Therapy in people with Multiple Sclerosis, run by Hacettepe 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 7 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: opening soon, as of the sponsor's last update on 27 Oct 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gizem Şekercan, PhD Student (+90 553 416 81 87, gizemsekercan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Fonksiyon Testi (WMFT) (time frame: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.). 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 27 Oct 2026.