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临床试验/NCT06838858
NCT06838858进行中(未招募)不适用

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

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
28
试验地点
1
主要终点
Range of Motion Measurement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Motor Imagery Training (Procedure)

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.

干预措施: Conventional Post-operative Exercises (Procedure)

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.

干预措施: Conventional Post-operative Exercises (Procedure)

结局指标

主要结局

Range of Motion Measurement

时间窗: Baseline, week 4, week 8

Range of Motion will be measured with using an universal goniometer for knee and ankle.

Muscle Strength

时间窗: Baseline, week 4, week 8

Manuel muscle testing will be done. It will graded 0 to 5. Five represents full strength.

Gait Assessment

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Functional Mobility(Baseline, week 4, week 8)
  • Foot pressure measurement(Baseline and week 8)
  • Movement imagery(Baseline, week 8)
  • Motor Imagery Training Fun and Clarity(After each therapy sessions)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meltem Çelik

Principal Investigator

Saglik Bilimleri Universitesi

研究点 (1)

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