NCT06838858

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

March 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

March 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 16, 2025

Last Update Submit

March 8, 2025

Conditions

Keywords

RehabilitationPost-operative RehabilitatonCerebral PalsySurgeryTenotomyMotor Imagery Training

Outcome Measures

Primary Outcomes (5)

  • Range of Motion Measurement

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

    Baseline, week 4, week 8

  • Muscle Strength

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

    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.

    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).

    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.

    Baseline and week 8

Secondary Outcomes (4)

  • 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

Study Arms (2)

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.

Procedure: Motor Imagery TrainingProcedure: 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.

Procedure: Conventional Post-operative Exercises

Interventions

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.

Motor Imagery Training Group in Addition to Post-Operative Exercise

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

Motor Imagery Training Group in Addition to Post-Operative ExercisePost-Operative Exercise Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (TĂ¼rkiye)

Location

Related Publications (28)

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MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • Zuhal Didem Takinacı, PhD

    Saglik Bilimleri Universitesi

    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
Principal Investigator

Study Record Dates

First Submitted

February 16, 2025

First Posted

February 21, 2025

Study Start

March 1, 2024

Primary Completion

May 5, 2024

Study Completion

March 15, 2025

Last Updated

March 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations