NCT03954808

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

May 16, 2019

Last Update Submit

October 9, 2020

Conditions

Keywords

Unilateral Cerebral Palsy, Motor imagery,

Outcome Measures

Primary Outcomes (2)

  • Movement Imagery Questionnaire-Children(MIQ-C)

    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

    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 Outcomes (16)

  • Gross Motor Function Classification System (GMFCS)

    At Baseline

  • Modified Tardieu Scale (MTS)

    Change from Baseline at 8 weeks and 14 weeks

  • Conner's Parent Rating Scale-Revised Short form (CPRS-RS)

    At Baseline

  • Mini-Mental State Exam For Children (Mmc)

    At Baseline

  • Surface electromyography (sEMG)

    Change from Baseline at 8 weeks and 14 weeks

  • +11 more secondary outcomes

Study Arms (3)

Motor imagery training group

EXPERIMENTAL

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.

Other: Motor Imagery Training

Cerebral Palsy control group

ACTIVE COMPARATOR

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).

Other: Traditional physiotherapy

Typically developing control group

NO INTERVENTION

Age matched healthy individuals, with no treatment.

Interventions

Motor imagery training will be designed for the individual basis with standard protocols

Motor imagery training group

Traditional physiotherapy within a specific program

Cerebral Palsy control group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, 14280, Turkey (Türkiye)

Location

Related Publications (3)

  • Steenbergen B, Craje C, Nilsen DM, Gordon AM. Motor imagery training in hemiplegic cerebral palsy: a potentially useful therapeutic tool for rehabilitation. Dev Med Child Neurol. 2009 Sep;51(9):690-6. doi: 10.1111/j.1469-8749.2009.03371.x.

    PMID: 19709140BACKGROUND
  • Steenbergen B, Jongbloed-Pereboom M, Spruijt S, Gordon AM. Impaired motor planning and motor imagery in children with unilateral spastic cerebral palsy: challenges for the future of pediatric rehabilitation. Dev Med Child Neurol. 2013 Nov;55 Suppl 4:43-6. doi: 10.1111/dmcn.12306.

    PMID: 24237279BACKGROUND
  • Lust JM, Wilson PH, Steenbergen B. Motor imagery difficulties in children with Cerebral Palsy: A specific or general deficit? Res Dev Disabil. 2016 Oct;57:102-11. doi: 10.1016/j.ridd.2016.06.010. Epub 2016 Jul 9.

    PMID: 27399206BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Eylem T Yümin

    Abant Izzet Baysal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 17, 2019

Study Start

June 1, 2019

Primary Completion

March 1, 2020

Study Completion

July 1, 2020

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations