Evaluation of the Effect of Mental Imagery Training Combined With Modified Constraint-Induced Movement Therapy in Individuals With Multiple Sclerosis

Browse trials for

• Multiple Sclerosis 3,264

Keywords

• multiple sclerosis
• Modified Constraint-Induced Movement Therapy
• Mental Imagery

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's planned enrollment of 14 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.

Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

Study arms

• Experimental
  Mental Imagery + mCIMT Group

  Participants will receive modified constraint-induced movement therapy combined with mental imagery training.

  Behavioral: odified Constraint-Induced Movement Therapy + Mental Imagery Training

• Active comparator
  mCIMT Group

  Participants will receive modified constraint-induced movement therapy alone.

  Behavioral: Modified Constraint-Induced Movement Therapy

Interventions

• Behavioralodified Constraint-Induced Movement Therapy + Mental Imagery Training

  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.

  Also known as: Experimental Group

• BehavioralModified Constraint-Induced Movement Therapy

  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.

  Also known as: Active Comparator

Primary outcomes

1. 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.

   Time frame: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.

Secondary outcomes

1. 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.

   Time frame: At baseline, immediately after the 3-week intervention

2. 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.

   Time frame: At baseline, immediately after the 3-week intervention

3. 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.

   Time frame: At baseline, immediately after the 3-week intervention

4. 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.

   Time frame: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.

5. 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.

   Time frame: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.

6. 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.

   Time frame: At baseline, immediately after the 3-week intervention, and at 1-month follow-up.

7. 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.

   Time frame: Immediately after the 3-week intervention.

Individual participant data

Plan to share: 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.