Motor Imagery Training in Children With Unilateral Cerebral Palsy

October 9, 2020 updated by: Demet Karabulut, Abant Izzet Baysal University

The Effect of Motor Imagery Training on Muscle Activity, Motor Imagery and Functional Movement Skills in Individuals Unilateral Cerebral Palsy

Motor imagery (MI) is a promising method to improve more cognitive aspects of motor behaviour, and may, thus, be effective for facilitating motor planning in children with Cerebral Palsy (CP). MI training facilitates the neural plasticity by enhancing the neuronal cortical pathways in brain. In children with CP, motor planning and MI capacity were found to be affected by studies. In the literature, there are studies about the evaluation of MI in Unilateral CP but there is insufficient number of studies included in MI in the rehabilitation program.

The aim of the study was to investigate the effect of motor imagery training for gait and lower extremity muscle activity (with EMG), functional capacity, quality of life, and time performance variables in Children with Unilateral CP.

The eligible participants will be allocated three groups, including motor imagery training group, traditional physiotherapy control group, and healthy control group. All the assessments will be performed before and after the training in the 8-week motor imagery training group and 6 weeks after the end of training. The participants in the control group will be evaluated with a 8-week interval and 6 weeks after the end of physiotherapy training. The healthy participants will be assessed only once. The motor imagery training will be designed for the individual basis with standard protocols. It will be applied two times a week for 8 weeks. All sessions will be performed in the clinic.

Study Overview

Status

Completed

Conditions

Detailed Description

Unilateral CP and age matched healthy individuals will be participate the study between the ages of 7 and 18 years. Children's gross motor skills classified with GMFCS.

The control group individuals will be given a traditional physiotherapy two days per week for a total of 8 weeks (traditional physiotherapy session will last 45 minutes). Motor imagery training group will receive a traditional physiotherapy and motor imagery training within a specific program, two days a week for a total of 8 weeks (30 minutes traditional physiotherapy session+15 minutes MI training) .

Within the scope of MI training, individual training program will be determined by taking into consideration the needs of the individuals and the expectations for gait. The basic case of PETTLEP (Physical, Environment, Task, Timing, Learning, Emotion, Perspective) will be followed. MI training will be given individually with the same physiotherapist.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bolu, Turkey, 14280
        • Bolu Abant İzzet Baysal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Cerebral Palsy voluntary participation
  • Age between 7-18 years, Children with Unilateral Cerebral Palsy
  • With suitable cognitive state for training
  • To attend a formal school
  • GMFCS Level I-II
  • IQ>70 Children with Unilateral Cerebral Palsy (from children's file)
  • Mini-Mental State Exam For Children score above 24

Exclusion Criteria:

  • Severe cognitive impairment and not able to follow task instructions
  • IQ<70 Children with Unilateral Cerebral Palsy (from children's file)
  • Who received motor imagery training last 6 months
  • Severe Vision and hearing problems
  • Botox or surgeries in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motor imagery training group
Children with Cerebral Palsy. Motor imagery training group will receive a traditional physiotherapy and motor imagery training within a specific program, two days a week for a total of 8 weeks (30 minutes traditional physiotherapy session+15 minutes MI training). The motor imagery training will be designed for the individual basis with standard protocols. All sessions will be performed in the clinic.
Motor imagery training will be designed for the individual basis with standard protocols
Active Comparator: Cerebral Palsy control group
Children with Cerebral Palsy. Traditional physiotherapy control group individuals will be given a traditional physiotherapy two days per week for a total of 8 weeks (traditional physiotherapy session will last 45 minutes).
Traditional physiotherapy within a specific program
No Intervention: Typically developing control group
Age matched healthy individuals, with no treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement Imagery Questionnaire-Children(MIQ-C)
Time Frame: Change from Baseline at 8 weeks and 14 weeks
Visual and Kinesthetic motor imagery ability will be evaluated with MIQ-C. Includes 12 items in total. The individual is asked to visualize four different movements from three different imagery perspectives. The clearness of the imagination is scored using a Likert-type scale between 1 (very difficult to feel) -7 (very easy to feel)
Change from Baseline at 8 weeks and 14 weeks
Mental Chronometry for Timed Up and Go Test
Time Frame: Change from Baseline at 8 weeks and 14 weeks
Motor imagery capacity will be evaluated by mental chronometry. This paradigm compares the duration between the actual movement and the imagined movement similar task duration. In this paradigm, participants are asked to do the Timed Up and Go test (TUG) and then they are asked to imaging the TUG. The timing of the imaging and actual movement will be determined by the stopwatch. Then compare the duration of actual and imagined movements. The temporal accuracy between actual and imagined movement will be calculated in terms of the delta time.
Change from Baseline at 8 weeks and 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Classification System (GMFCS)
Time Frame: At Baseline
Assessing severity of the disability and motor function. Gross motor functions of children with CP are classified in five levels with GMFCS. This is a classification system based on the child's self-initiated movements with emphasis on sitting, displacement and mobility.
At Baseline
Modified Tardieu Scale (MTS)
Time Frame: Change from Baseline at 8 weeks and 14 weeks
Assessing muscle tone of individuals. It evaluates reaction of the muscle to passive movement of limb both slow and fast speeds. This scale evaluated the speed-dependent nature of spasticity. Quality of muscle reaction (X) and the angle of muscle reaction (Y) are determined by the modified tardieu scale. If quality of muscle reaction score was 2 or higher, the joint angle in which the muscle responds with difficulty will be measured goniometer. The Modified Tardieu Scale scores range from 0 to 5. Scoring: 0= no resistance to passive movement. 1= slight resistance throughout the course of the passive movement. 2= there's a clear catching at a precise angle, which makes passive movement difficult, followed by a release. 3= fatigable clonus (Less than 10 seconds). 4= infatigable clonus (More than 10 seconds). 5= the joint cannot be moved.
Change from Baseline at 8 weeks and 14 weeks
Conner's Parent Rating Scale-Revised Short form (CPRS-RS)
Time Frame: At Baseline
Assessing whether individuals' levels of attention differ from between groups. The questionnaire consisted of 27 items and three sub-dimensions (Oppositionality, Hyperactivity, Cognitive Problems-Inattention). Response formats are in the form of a four-point Likert type scale. Answer options and scoring are as follows: 0 points are never correct, 3 points are very accurate, with total scores ranging from 0 to 81. Cognitive Problems-Inattention subscale has the minimum score is 0 and the maximum score is 18. Higher scores are reflective of worse situations of attention.
At Baseline
Mini-Mental State Exam For Children (Mmc)
Time Frame: At Baseline
Mini-Mental State Exam For Children (Mmc) consists of 15 questions designed to assess the cognitive functions of the individual. Includes recording, recall, attention and calculation, temporal orientation, spatial orientation, and language measurement. It takes about 15 minutes to perform.
At Baseline
Surface electromyography (sEMG)
Time Frame: Change from Baseline at 8 weeks and 14 weeks
Surface electromyography is a non-invasive method that involves taking, recording and interpreting the electric activity of muscle groups. Delsys Trigno Wireless System superficial EMG (sEMG) device will be used for evaluation of muscle activation. Measurements will be made in accordance with the criteria of SENIAM (surface EMG for non-invasive assessment of muscle) and the literature. Activation of lower extremity muscles through silver-silver chloride (Ag-AgCl) disposable adhesive electrodes will be evaluated.
Change from Baseline at 8 weeks and 14 weeks
Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame: Change from Baseline at 8 weeks and 14 weeks
Assessing disability and activity and participation. 0: can not do, 1: can do in the form of scoring is done. At the end of the evaluation, the points of the related section are collected.
Change from Baseline at 8 weeks and 14 weeks
Pediatric Outcomes Date Collection (PODCI) (Questionnaire)
Time Frame: Change from Baseline at 8 weeks and 14 weeks
Assessing health-related quality of life, activity and participation. It consists of five basic sub-groups; upper extremity functions, physical function and sport, transfer and base mobility, pain, happiness / satisfaction.
Change from Baseline at 8 weeks and 14 weeks
Timed Up and Go Test
Time Frame: Change from Baseline at 8 weeks and 14 weeks
The Timed Up and Go test (TUG) is a simple test used to assess functional mobility, dynamic balance, walking speed and postural stability. The individual is asked to rise from chair, walk three meters safe and normal speed, turn around, walk back to the chair and sit down. The time is calculated in seconds from the start of the instruction to ends when the patient is seated.
Change from Baseline at 8 weeks and 14 weeks
10-Meter Walk Test
Time Frame: Change from Baseline at 8 weeks and 14 weeks
The individual is asked to walk the distance of 10 meter three times with the maximum speed that he or she wants can walk and the average time is recorded.
Change from Baseline at 8 weeks and 14 weeks
Five Times Sit to Stand Test
Time Frame: Change from Baseline at 8 weeks and 14 weeks
This test is associated with lower extremity muscle strength and balance. During the test, the individual is asked to stand up and sit for five times without holding up from the chair and the elapsed time is recorded.
Change from Baseline at 8 weeks and 14 weeks
Mental Chronometry for 10-Meter Walk Test
Time Frame: Change from Baseline at 8 weeks and 14 weeks
Motor imagery capacity is evaluated by mental chronometry. This paradigm compares the duration between the actual movement and the imagined movement similar task duration. In this paradigm, participants are asked to do the 10-Meter Walk Test and then they are asked to imaging the this test. The timing of the imaging and actual movement will be determined by the stopwatch. Then compare the duration of actual and imagined movements. The temporal accuracy between actual and imagined movement will be calculated in terms of the delta time.
Change from Baseline at 8 weeks and 14 weeks
Mental Chronometry for Five Times Sit to Stand Test
Time Frame: Change from Baseline at 8 weeks and 14 weeks
Motor imagery capacity is evaluated by mental chronometry. This paradigm compares the duration between the actual movement and the imagined movement similar task duration. In this paradigm, participants are asked to do the Five Times Sit to Stand Test and then they are asked to imaging the this test. The timing of the imaging and actual movement will be determined by the stopwatch. Then compare the duration of actual and imagined movements. The temporal accuracy between actual and imagined movement will be calculated in terms of the delta time.
Change from Baseline at 8 weeks and 14 weeks
Laterality Task
Time Frame: Change from Baseline at 8 weeks and 14 weeks
This task evaluates the left-right discrimination and implicit imagery. Two aspects will be evaluated in the task of recognition of the foot's laterality. First, the precision (percentage of right answers) of the discrimination of the laterality which is the capacity to recognize whether a part of the body belongs to the right or left and second the response time of the participants use in the discrimination task. NOI group designed and developed application about this will be used.
Change from Baseline at 8 weeks and 14 weeks
Functional muscle strength
Time Frame: Change from Baseline at 8 weeks and 14 weeks
The 30s Repetition Maximum test will be used to assess functional muscle strength of the lower extremities. The three closed kinetic chain exercises of lateral step-up test, sit to stand test, and attain stand through half knee test will be used.
Change from Baseline at 8 weeks and 14 weeks
Motor imagery entertainment scale
Time Frame: Change from Baseline at 4 weeks and 8 weeks
The entertainment level of motor imagery sessions and imagery training for individuals will be evaluated with a 0-10 point numerical rating scale (entertainment scale). There are numbers from 0 to 10 on the horizontal line of 10 cm. 0 "Not fun" on the line in the scale; 10 represents "a lot of fun". Entertainment rating will be recorded numerically from 0 to 10.
Change from Baseline at 4 weeks and 8 weeks
Motor imagery clarity scale
Time Frame: Change from Baseline at 4 weeks and 8 weeks

The clarity level of motor imagery sessions and imagery training for individuals will be evaluated with a 0-10 point numerical rating scale (clarity scale). There are numbers from 0 to 10 on the horizontal line of 10 cm.

On the horizontal 10 cm horizontal line, 0 means that the visualization never occurs, and 10 indicates that it is very clear. Clarity rating will be recorded numerically from 0 to 10.

Change from Baseline at 4 weeks and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Eylem T Yümin, Abant Izzet Baysal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (Actual)

May 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 9, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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