RehabilitationNCT06838858
Effects of Motor Imagery Training After Muscle Lengthening Surgery in Children With Cerebral Palsy
A study testing Motor Imagery Training and Conventional Post-operative Exercises in people with Rehabilitation and Cerebral Palsy (CP), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In children with cerebral palsy (CP), spasticity occurs in the muscles due to upper motor neuron lesions. The muscle groups that are mostly spastic in the lower extremity are; the hip adductor and flexors, hamstrings, and ankle plantar flexors. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Rehabilitation, Cerebral Palsy (CP), Exercise
- What is being tested?
- Motor Imagery Training and Conventional Post-operative Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 15 Mar 2025
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis with Cerebral Palsy
- Being between the ages of 7-18
- Being able to walk with or without support
- Not having received botulinum toxin injections into the ankle plantar flexor muscles in the last 6 months
- Being at the GMFCS level of 1,2 or 3
- Having an indication for ankle muscle release surgery and having a surgical plan
- Being receiving a developmental rehabilitation program
- Being able to follow given commands
Who cannot join
- Having dyskinetic, ataxic or hypotonic involvement
- Having any neurosurgery before
- Having any bone surgery for the foot or ankle before
- Having a bone surgery in the same session
- Mental retardation and not being able to take commands
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Early Effects of Motor Imagery Training on Balance, Walking and Quality of Life After Ankle Plantar Flexor Muscle Lengthening Surgery in Children With Cerebral Palsy
In children with cerebral palsy (CP), spasticity occurs in the muscles due to upper motor neuron lesions. The muscle groups that are mostly spastic in the lower extremity are; the hip adductor and flexors, hamstrings, and ankle plantar flexors. Spasticity in the ankle plantar flexor muscles of these muscle groups causes contracture over time and restricts ankle dorsiflexion. Limitations in ankle dorsiflexion present as toe walking problems, balance loss, and various functional difficulties in children. Children with spasticity of the ankle plantar flexor muscles gastrocnemius and soleus are initially treated conservatively with exercise and positioning. However, after contracture occurs, treatment is performed using surgical methods. Surgical release of plantar flexor muscles is a method that has been proven to be effective and is frequently applied in the clinic. This surgery aims to remove the ankle dorsiflexion joint range of motion restriction, prevent toe walking, and improve the functional status of the child. However, since the plantar flexor muscles are in the antigravity muscle group, excessive release of these muscles can cause loss of balance and crouch gait. Therefore, it is important for this surgery to be performed by an experienced surgical team at the right time and to provide an exercise protocol aimed at stabilization by working both muscle groups in the postoperative period. In addition, after these surgeries, the patient is immobilized with a cast and orthosis for a while and the patient's active and passive movements are restricted with these devices. Motor Imagery; It is the process of learning a new movement or improving the quality of a known movement by visualizing it in a planned and intensive way in the mind of the person without performing any motor activity. This study hypothesized that the motor imagery training in the early rehabilitation process with movement restrictions after plantar flexor muscle relaxation operations will be effective on the patient's balance, walking, and quality of life.
Read the detailed description
Cerebral palsy (CP) is a pathology that occurs as a result of a non-progressive lesion in the brain that develops due to various risk factors that may occur before, during, or after birth. The spastic type is the most common type of CP. Children with CP experience various problems in physical, psychological, mental, and social areas depending on the affected area of the brain and the degree of involvement. Motor function losses are the primary problem in individuals with CP. Children are classified according to the level of involvement with the gross motor function scale (GMFCS). While GMFCS level 1 indicates the mildest involvement, GMFCS level 5 indicates the most severe involvement.
Spasticity that occurs in the affected areas of the body after upper motor neuron lesions directly negatively affects the child's muscle and joint functions. The muscle groups where spasticity is commonly and frequently seen in the lower extremities are the hip adductor muscles, hamstrings, and ankle plantar flexor muscles. Ankle plantar flexor muscle spasticity can be seen in children of all GMFCS levels and negatively affects the child's functional status and reduces compliance with orthosis use. Increased ankle plantar flexor spasticity causes contracture in the ankle plantar flexors over time, which restricts ankle dorsiflexion. This condition often causes toe walking in children. Toe walking disrupts the child's general body balance and also negatively affects other upper segments, especially the knee joint.
The primary treatment option in the presence of ankle plantar flexor muscle spasticity is conservative treatment. Conservative treatment includes positioning the ankle in dorsiflexion and strengthening the dorsiflexor muscles, stretching the ankle plantar flexor muscles, performing relaxation exercises on the same muscle group, transferring weight in the appropriate position, and walking exercises.
In addition, in the presence of dynamic spasticity, the effectiveness of botulinum neurotoxin injection applied to the ankle plantar flexor muscles in cases where conservative treatment is inadequate has been shown in the literature. In cases where all these methods are inadequate, plantar flexor muscle contracture is present, and the child is functionally negatively affected, lengthening surgeries performed on the plantar flexor muscles are indicated. This operation can be performed only on the gastrocnemius muscle or on the Achilles tendon, which includes both the gastrocnemius and soleus muscles.
The ankle plantar flexor muscles are included in the antigravity muscle group and have an important role in general body balance. The length and strength of these muscles at a certain rate provide stabilization of the body segments. While the increased tone of these muscles disrupts this stabilization, the inability of the elongated muscle to provide sufficient core support after relaxations results in excessive dorsiflexion and suggests that it may cause walking problems and ultimately loss of balance. Therefore, when deciding on plantar flexor muscle relaxation operations applied to children with CP, it is thought that the right timing should be provided and the surgery should be performed with an experienced team in sufficient and correct amounts, and post-operative rehabilitation protocols that include intensive studies on gaining balance and stabilization in the post-operative period will increase balance and walking control.
Motor Imagery; It is the process of learning a new movement or increasing the quality of a known movement by visualizing it in a planned and intensive manner in the mind without performing any motor activity. In imagery, while not actually doing any activity; it is possible to experience it through mental imagery by seeing the image in the mind, feeling the movement as in the image, sensing the taste or smell of the image, and hearing its sound. The effectiveness of motor imagery training has been shown in children with CP. There is no study on its effectiveness in the postoperative period.
This study hypothesizes that motor imagery training, which will be applied in addition to the post-operative rehabilitation program, is effective on balance, walking, and quality of life, especially in children with CP, in the rehabilitation process where there is a mandatory restriction with plaster and orthosis after ankle plantar flexor muscle lengthening surgeries. The primary aim of this study is to examine the effect of motor imagery training, which will be applied in addition to post-operative rehabilitation after ankle plantar flexor muscle release operations in individuals with CP, on balance, gait, and quality of life.
- Conditions
- Rehabilitation, Cerebral Palsy (CP), Exercise, Tenotomy, Motor Imagery Training, Orthopedic Surgery
- Being tested
- Motor Imagery Training, Conventional Post-operative Exercises
- Keywords
- Rehabilitation, Post-operative Rehabilitaton, Cerebral Palsy, Surgery, Tenotomy, Motor Imagery Training
- Medical subject headings
- Cerebral Palsy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imagery TrainingProcedure or surgery
The study group will receive motor imagery training in addition to control group's exercise program. This process will proceed as follows; In motor imagery training videos taken with a 9-year-old healthy child will be watched.• The content of the videos will include exercises such as ankle dorsiflexion, heel tapping while walking, climbing and descending stairs, walking on a ramp, standing on a ramp, walking on soft ground, and walking on a treadmill.• The patients will watch these videos and then the relaxation, imagination and return to environment phases of motor imagery will be applied respectively.
Conventional Post-operative ExercisesProcedure or surgery
This group will receive conventional exercises in the post-op process. The exercises included in the conventional exercise program are;
- Balance board exercises
- Balance disc exercises
- Bosu exercises
- Balance pad exercises
- Wobble board exercises
- Walking on soft ground
- Balance exercises on soft ground
- Apraximations and tractions
- Target angle exercise for ankle
- General standing balance exercises (Eyes open and closed - single foot, double foot)
- Ankle bidirectional ROM
- Ankle bidirectional strengthening
- Exercises to increase foot intrinsic muscle strength and balance
- Functional exercises
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery Training Group in Addition to Post-Operative Exercise | Active comparator | The study group will receive motor imagery exercises in addition to the post-op rehabilitation received by the comparison group. The exercises will given in a hibrit method (a face to face therapy session and 2 telerehabilitation session in an online platform in a week).
The telerehabilitation sessions will given under the supervision of a remote physiotherapist. This group will take therapy sessions during 8 weeks. All the patients will have totally 8 face to face therapy sessions and 16 telerehabilitation sessions. Receives: Procedure: Motor Imagery Training; Procedure: Conventional Post-operative Exercises |
| Post-Operative Exercise Group | Active comparator | This group will be included in a conventional post-operative rehabilitation program that includes intensive foot intrinsic muscle balance, bilateral ankle strengthening and range of motion exercises, and general body balance studies after plantar flexor muscle relaxation operations. In the rehabilitation program of the case group, exercises are planned under the supervision of a remote physiotherapist, with the telerehabilitation method (online live sessions) 2 days and 1 face to face therapy session will be done in a week. face therapy sessions and 16 telerehabilitation sessions. Receives: Procedure: Conventional Post-operative Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion Measurement
Range of Motion will be measured with using an universal goniometer for knee and ankle.
Measured: Baseline, week 4, week 8
Muscle Strength
Manuel muscle testing will be done. It will graded 0 to 5. Five represents full strength.
Measured: Baseline, week 4, week 8
Gait Assessment
It will be asseessed with using Edinburg Visual Gait Scorring (EVGS). EVGS is a video based gait scorring system. It consist of 17 items. A gait video will be taken from sagital and coronal plan. It will scorred later.
Additionally, pedobarographic measurements for temporospatial gait parameters will be obtained with Enertor foot scanning system (RSscan Lab Ltd; UK).
The temporospatial gait parameters are; step length, stride length, Step width, cadance, double support time, single support time.
Measured: Baseline and week 8
Balance Assessment
It will done by using Pediatric Balance Scale. There are 14 items in this scale. The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills during tasks that mimic experiences of everyday living in school-aged children. The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Additionally, pedobarographic measurements for static balance assessment will be obtained with Enertor foot scanning system (RSscan Lab Ltd; UK).
Measured: Baseline, week 8
Quality of Life Assessment
Quality of life assessments of patients will be made using the Quality of Life Scale for Children. The first version of the scale (PedsQL TM 1.0) is a general quality of life scale developed for use in various pediatric populations. The most powerful version, the fourth version's core scale (PedsQL TM 4.0 Generic Core Scale), is a scale that evaluates the basic physical, mental and social health components determined by the World Health Organization in healthy children or those with acute or chronic diseases, together with school functionality. This scale consists of a total of 23 items and 4 subscales, including 8 items measuring physical functionality, 5 items measuring emotional functionality, 5 items measuring social functionality and 5 items evaluating school functionality.
Measured: Baseline and week 8
Secondary outcomes (4)
Functional Mobility
Functional status and ambulation assessment of patients will be made with the Functional Mobility Scale (FMS). The Functional Mobility Scale is a scale that evaluates how patients walk 5, 50 and 500 meters and ultimately divides them into 6 groups.
Measured: Baseline, week 4, week 8
Foot pressure measurement
The pedobarograph is a device displaying and recording the instantaneous distribution of the pressure under the entire surface of the soles of the feet. The subject stands or walks on a transparent plate, in which light is conducted by total internal reflections. For the assessment of foot pressure, pedobarographic measurements will be obtained with the Enertor foot scanning system (RSscan Lab Ltd; UK).
Measured: Baseline and week 8
Movement imagery
It will be assessed by usisng Movement imagery questionnaire for children-MIQ-C. This questionnaire was used to measure visual (internal, external skills) and kinesthetic imagery. It contains a total of 12 items, 4 items internal, 4 items external, and 4 items kinesthetic imagery skills. Within the scope of the questionnaire, the individual is asked to imagine 4 different movements from 3 different visual perspectives. During this test applied with the evaluator, the individual is asked to do the movement in the instructions once in reality and then to imagine doing the movement, and the clarity of this imagery is scored using a Likert-type scale between 1 (very difficult to feel) and 7 (very easy to feel). The questionnaire was developed by Martini et al..
Measured: Baseline, week 8
Motor Imagery Training Fun and Clarity
An additional evaluation will be made with the Motor Imagery Training Fun and Clarity Scale. The fun level of motor imagery sessions and imagery training for individuals will be evaluated using a 0-10 point numerical rating scale (fun scale). There will be numbers from 0 to 10 on a 10 cm horizontal line. On the scale, 0 on the line means "not fun at all" and 10 means "very fun". The degree of fun will be recorded numerically between 0 and 10. Similarly, how clearly they can visualize the tasks imagined during the imagery sessions will be evaluated with a 0-10 point numerical rating scale (clarity scale). Individuals will be asked to evaluate clarity by stating that 0 on a 10 cm horizontal line means that imagery is not clear at all, and 10 means it is very clear.
Measured: After each therapy sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Mar 2024
- Primary completion5 May 2024
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Çelik, Saglik Bilimleri Universitesi
- Investigators
- Zuhal Didem Takinacı, PhD, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838858
- Sponsor's protocol ID
- MCDT-2025
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hartrick CT, Kovan JP, Shapiro S. The numeric rating scale for clinical pain measurement: a ratio measure? Pain Pract. 2003 Dec;3(4):310-6. doi: 10.1111/j.1530-7085.2003.03034.x.
PubMed 1716612629. Crichton, N. (2001). Visual analogue scale (VAS). J Clin Nurs, 10(5), 706-6.
28. Doussoulin, A., & Rehbein, L. (2011). Motor imagery as a tool for motor skill training in children. Motricidade, 7(3), 37-43.
Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499Ottenbacher KJ, Taylor ET, Msall ME, Braun S, Lane SJ, Granger CV, Lyons N, Duffy LC. The stability and equivalence reliability of the functional independence measure for children (WeeFIM). Dev Med Child Neurol. 1996 Oct;38(10):907-16. doi: 10.1111/j.1469-8749.1996.tb15047.x.
PubMed 8870612Xu C, Wen XX, Huang LY, Shang L, Cheng XX, Yan YB, Lei W. Normal foot loading parameters and repeatability of the Footscan(R) platform system. J Foot Ankle Res. 2017 Jul 17;10:30. doi: 10.1186/s13047-017-0209-2. eCollection 2017.
PubMed 28725271Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
PubMed 17057441Graham HK, Harvey A, Rodda J, Nattrass GR, Pirpiris M. The Functional Mobility Scale (FMS). J Pediatr Orthop. 2004 Sep-Oct;24(5):514-20. doi: 10.1097/00004694-200409000-00011.
PubMed 1530890122. Abd El-Raheem, R. M., Kamel, R. M., & Ali, M. F. (2015). Reliability of using Kinovea program in measuring dominant wrist joint range of motion. Trends in Applied Sciences Research, 10(4), 224.
Read HS, Hazlewood ME, Hillman SJ, Prescott RJ, Robb JE. Edinburgh visual gait score for use in cerebral palsy. J Pediatr Orthop. 2003 May-Jun;23(3):296-301.
PubMed 12724590Rodda JM, Graham HK, Carson L, Galea MP, Wolfe R. Sagittal gait patterns in spastic diplegia. J Bone Joint Surg Br. 2004 Mar;86(2):251-8. doi: 10.1302/0301-620x.86b2.13878.
PubMed 1504644219. Palisano, R., Rosenbaum, P., Bartlett, D., Livingston, M., Walter, S., & Russell, D. (2007). GMFCS-E&R. CanChild Centre for Childhood Disability Research, McMaster University, 200(7).
Verschuren O, Ketelaar M, Takken T, Van Brussel M, Helders PJ, Gorter JW. Reliability of hand-held dynamometry and functional strength tests for the lower extremity in children with Cerebral Palsy. Disabil Rehabil. 2008;30(18):1358-66. doi: 10.1080/09638280701639873.
PubMed 18850351Boone DC, Azen SP, Lin CM, Spence C, Baron C, Lee L. Reliability of goniometric measurements. Phys Ther. 1978 Nov;58(11):1355-60. doi: 10.1093/ptj/58.11.1355.
PubMed 70468415. Cohen, J, (1988), Statistical Power Analysis for the behavioral sciences, 2. Edition, Taylor & Francis INC, New York, US.)
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Early Effects of Motor Imagery Training on Balance, Walking and Quality of Life After Ankle Plantar Flexor Muscle Lengthening Surgery in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06838858
- Acronym / sponsor ID
- MCDT-2025
- Conditions
- Rehabilitation, Cerebral Palsy (CP), Exercise, Tenotomy, Motor Imagery Training, Orthopedic Surgery
- Keywords
- Rehabilitation, Post-operative Rehabilitaton, Cerebral Palsy, Surgery, Tenotomy, Motor Imagery Training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 21 Feb 2025 (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.
In children with cerebral palsy (CP), spasticity occurs in the muscles due to upper motor neuron lesions. The muscle groups that are mostly spastic in the lower extremity are; the hip adductor and flexors, hamstrings, and ankle plantar flexors. Spasticity in the ankle plantar flexor muscles of these muscle groups causes contracture over time and restricts ankle dorsiflexion. Limitations in ankle dorsiflexion present as toe walking problems, balance loss, and various functional difficulties in children. Children with spasticity of the ankle plantar flexor muscles gastrocnemius and soleus are initially treated conservatively with exercise and positioning. However, after contracture occurs, treatment is performed using surgical methods. Surgical release of plantar flexor muscles is a method that has been proven to be effective and is frequently applied in the clinic. This surgery aims to remove the ankle dorsiflexion joint range of motion restriction, prevent toe walking, and improve the functional status of the child. However, since the plantar flexor muscles are in the antigravity muscle group, excessive release of these muscles can cause loss of balance and crouch gait. Therefore, it is important for this surgery to be performed by an experienced surgical team at the right time and to provide an exercise protocol aimed at stabilization by working both muscle groups in the postoperative period. In addition, after these surgeries, the patient is immobilized with a cast and orthosis for a while and the patient's active and passive movements are restricted with these devices. Motor Imagery; It is the process of learning a new movement or improving the quality of a known movement by visualizing it in a planned and intensive way in the mind of the person without performing any motor activity. This study hypothesized that the motor imagery training in the early rehabilitation process with movement restrictions after plantar flexor muscle relaxation operations will be effective on the patient's balance, walking, and quality of life.
Detailed description
Cerebral palsy (CP) is a pathology that occurs as a result of a non-progressive lesion in the brain that develops due to various risk factors that may occur before, during, or after birth. The spastic type is the most common type of CP. Children with CP experience various problems in physical, psychological, mental, and social areas depending on the affected area of the brain and the degree of involvement. Motor function losses are the primary problem in individuals with CP. Children are classified according to the level of involvement with the gross motor function scale (GMFCS). While GMFCS level 1 indicates the mildest involvement, GMFCS level 5 indicates the most severe involvement.
Spasticity that occurs in the affected areas of the body after upper motor neuron lesions directly negatively affects the child's muscle and joint functions. The muscle groups where spasticity is commonly and frequently seen in the lower extremities are the hip adductor muscles, hamstrings, and ankle plantar flexor muscles. Ankle plantar flexor muscle spasticity can be seen in children of all GMFCS levels and negatively affects the child's functional status and reduces compliance with orthosis use. Increased ankle plantar flexor spasticity causes contracture in the ankle plantar flexors over time, which restricts ankle dorsiflexion. This condition often causes toe walking in children. Toe walking disrupts the child's general body balance and also negatively affects other upper segments, especially the knee joint.
The primary treatment option in the presence of ankle plantar flexor muscle spasticity is conservative treatment. Conservative treatment includes positioning the ankle in dorsiflexion and strengthening the dorsiflexor muscles, stretching the ankle plantar flexor muscles, performing relaxation exercises on the same muscle group, transferring weight in the appropriate position, and walking exercises.
In addition, in the presence of dynamic spasticity, the effectiveness of botulinum neurotoxin injection applied to the ankle plantar flexor muscles in cases where conservative treatment is inadequate has been shown in the literature. In cases where all these methods are inadequate, plantar flexor muscle contracture is present, and the child is functionally negatively affected, lengthening surgeries performed on the plantar flexor muscles are indicated. This operation can be performed only on the gastrocnemius muscle or on the Achilles tendon, which includes both the gastrocnemius and soleus muscles.
The ankle plantar flexor muscles are included in the antigravity muscle group and have an important role in general body balance. The length and strength of these muscles at a certain rate provide stabilization of the body segments. While the increased tone of these muscles disrupts this stabilization, the inability of the elongated muscle to provide sufficient core support after relaxations results in excessive dorsiflexion and suggests that it may cause walking problems and ultimately loss of balance. Therefore, when deciding on plantar flexor muscle relaxation operations applied to children with CP, it is thought that the right timing should be provided and the surgery should be performed with an experienced team in sufficient and correct amounts, and post-operative rehabilitation protocols that include intensive studies on gaining balance and stabilization in the post-operative period will increase balance and walking control.
Motor Imagery; It is the process of learning a new movement or increasing the quality of a known movement by visualizing it in a planned and intensive manner in the mind without performing any motor activity. In imagery, while not actually doing any activity; it is possible to experience it through mental imagery by seeing the image in the mind, feeling the movement as in the image, sensing the taste or smell of the image, and hearing its sound. The effectiveness of motor imagery training has been shown in children with CP. There is no study on its effectiveness in the postoperative period.
This study hypothesizes that motor imagery training, which will be applied in addition to the post-operative rehabilitation program, is effective on balance, walking, and quality of life, especially in children with CP, in the rehabilitation process where there is a mandatory restriction with plaster and orthosis after ankle plantar flexor muscle lengthening surgeries. The primary aim of this study is to examine the effect of motor imagery training, which will be applied in addition to post-operative rehabilitation after ankle plantar flexor muscle release operations in individuals with CP, on balance, gait, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery Training Group in Addition to Post-Operative Exercise | Active comparator | Procedure: Motor Imagery Training, Procedure: Conventional Post-operative ExercisesThe study group will receive motor imagery exercises in addition to the post-op rehabilitation received by the comparison group. The exercises will given in a hibrit method (a face to face therapy session and 2 telerehabilitation session in an online platform in a week). The telerehabilitation sessions will given under the supervision of a remote physiotherapist. This group will take therapy sessions during 8 weeks. All the patients will have totally 8 face to face therapy sessions and 16 telerehabilitation sessions. |
| Post-Operative Exercise Group | Active comparator | Procedure: Conventional Post-operative ExercisesThis group will be included in a conventional post-operative rehabilitation program that includes intensive foot intrinsic muscle balance, bilateral ankle strengthening and range of motion exercises, and general body balance studies after plantar flexor muscle relaxation operations. In the rehabilitation program of the case group, exercises are planned under the supervision of a remote physiotherapist, with the telerehabilitation method (online live sessions) 2 days and 1 face to face therapy session will be done in a week. face therapy sessions and 16 telerehabilitation sessions. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Diagnosis with Cerebral Palsy
- Being between the ages of 7-18
- Being able to walk with or without support
- Not having received botulinum toxin injections into the ankle plantar flexor muscles in the last 6 months
- Being at the GMFCS level of 1,2 or 3
Key exclusion criteria (5 listed)
- Having dyskinetic, ataxic or hypotonic involvement
- Having any neurosurgery before
- Having any bone surgery for the foot or ankle before
- Having a bone surgery in the same session
- Mental retardation and not being able to take commands
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 |
|---|---|---|
| Motor Imagery TrainingThe study group will receive motor imagery training in addition to control group's exercise program. This process will proceed as follows; In motor imagery training videos taken with a 9-year-old healthy child will be watched.• The content of the videos will include exercises such as ankle dorsiflexion, heel tapping while walking, climbing and descending stairs, walking on a ramp, standing on a ramp, walking on soft ground, and walking on a treadmill.• The patients will watch these videos and then the relaxation, imagination and return to environment phases of motor imagery will be applied respectively. | Procedure or surgery | Motor Imagery Training Group in Addition to Post-Operative Exercise |
| Conventional Post-operative ExercisesThis group will receive conventional exercises in the post-op process. The exercises included in the conventional exercise program are; * Balance board exercises * Balance disc exercises * Bosu exercises * Balance pad exercises * Wobble board exercises * Walking on soft ground * Balance exercises on soft ground * Apraximations and tractions * Target angle exercise for ankle * General standing balance exercises (Eyes open and closed - single foot, double foot) * Ankle bidirectional ROM * Ankle bidirectional strengthening * Exercises to increase foot intrinsic muscle strength and balance * Functional exercises | Procedure or surgery | Motor Imagery Training Group in Addition to Post-Operative Exercise, Post-Operative Exercise Group |
Primary outcome
Range of Motion Measurement
Time frame: Baseline, week 4, week 8
Range of Motion will be measured with using an universal goniometer for knee and ankle.
Muscle Strength
Time frame: Baseline, week 4, week 8
Manuel muscle testing will be done. It will graded 0 to 5. Five represents full strength.
Gait Assessment
Time frame: Baseline and week 8
It will be asseessed with using Edinburg Visual Gait Scorring (EVGS). EVGS is a video based gait scorring system. It consist of 17 items. A gait video will be taken from sagital and coronal plan. It will scorred later. Additionally, pedobarographic measurements for temporospatial gait parameters will be obtained with Enertor foot scanning system (RSscan Lab Ltd; UK). The temporospatial gait parameters are; step length, stride length, Step width, cadance, double support time, single support time.
Balance Assessment
Time frame: Baseline, week 8
It will done by using Pediatric Balance Scale. There are 14 items in this scale. The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills during tasks that mimic experiences of everyday living in school-aged children. The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. Additionally, pedobarographic measurements for static balance assessment will be obtained with Enertor foot scanning system (RSscan Lab Ltd; UK).
Quality of Life Assessment
Time frame: Baseline and week 8
Quality of life assessments of patients will be made using the Quality of Life Scale for Children. The first version of the scale (PedsQL TM 1.0) is a general quality of life scale developed for use in various pediatric populations. The most powerful version, the fourth version's core scale (PedsQL TM 4.0 Generic Core Scale), is a scale that evaluates the basic physical, mental and social health components determined by the World Health Organization in healthy children or those with acute or chronic diseases, together with school functionality. This scale consists of a total of 23 items and 4 subscales, including 8 items measuring physical functionality, 5 items measuring emotional functionality, 5 items measuring social functionality and 5 items evaluating school functionality.
4 secondary outcomes
Functional Mobility
Time frame: Baseline, week 4, week 8
Foot pressure measurement
Time frame: Baseline and week 8
Movement imagery
Time frame: Baseline, week 8
Motor Imagery Training Fun and Clarity
Time frame: After each therapy sessions
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 12 Mar 2025.
- Background: PubMed 17166126Hartrick CT, Kovan JP, Shapiro S. The numeric rating scale for clinical pain measurement: a ratio measure? Pain Pract. 2003 Dec;3(4):310-6. doi: 10.1111/j.1530-7085.2003.03034.x.
- Background29. Crichton, N. (2001). Visual analogue scale (VAS). J Clin Nurs, 10(5), 706-6.
- Background28. Doussoulin, A., & Rehbein, L. (2011). Motor imagery as a tool for motor skill training in children. Motricidade, 7(3), 37-43.
- Background: PubMed 11468499Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
- Background: PubMed 8870612Ottenbacher KJ, Taylor ET, Msall ME, Braun S, Lane SJ, Granger CV, Lyons N, Duffy LC. The stability and equivalence reliability of the functional independence measure for children (WeeFIM). Dev Med Child Neurol. 1996 Oct;38(10):907-16. doi: 10.1111/j.1469-8749.1996.tb15047.x.
- Background: PubMed 28725271Xu C, Wen XX, Huang LY, Shang L, Cheng XX, Yan YB, Lei W. Normal foot loading parameters and repeatability of the Footscan(R) platform system. J Foot Ankle Res. 2017 Jul 17;10:30. doi: 10.1186/s13047-017-0209-2. eCollection 2017.
- Background: PubMed 17057441Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
- Background: PubMed 15308901Graham HK, Harvey A, Rodda J, Nattrass GR, Pirpiris M. The Functional Mobility Scale (FMS). J Pediatr Orthop. 2004 Sep-Oct;24(5):514-20. doi: 10.1097/00004694-200409000-00011.
- Background22. Abd El-Raheem, R. M., Kamel, R. M., & Ali, M. F. (2015). Reliability of using Kinovea program in measuring dominant wrist joint range of motion. Trends in Applied Sciences Research, 10(4), 224.
- Background: PubMed 12724590Read HS, Hazlewood ME, Hillman SJ, Prescott RJ, Robb JE. Edinburgh visual gait score for use in cerebral palsy. J Pediatr Orthop. 2003 May-Jun;23(3):296-301.
- Background: PubMed 15046442Rodda JM, Graham HK, Carson L, Galea MP, Wolfe R. Sagittal gait patterns in spastic diplegia. J Bone Joint Surg Br. 2004 Mar;86(2):251-8. doi: 10.1302/0301-620x.86b2.13878.
- Background19. Palisano, R., Rosenbaum, P., Bartlett, D., Livingston, M., Walter, S., & Russell, D. (2007). GMFCS-E&R. CanChild Centre for Childhood Disability Research, McMaster University, 200(7).
- Individual participant dataSharing planned: No
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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.
Zuhal Didem Takinacı, PhD study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery Training and Conventional Post-operative Exercises in people with Rehabilitation and Cerebral Palsy (CP), run by Saglik Bilimleri Universitesi 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 5 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: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2025. 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?
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?
Range of Motion Measurement (time frame: Baseline, week 4, week 8). The study lists 5 primary outcomes in all. 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 NCT06838858, which also lists 28 linked publications.
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 12 Mar 2025.