NCT06676332

Brief Summary

PURPOSE: The current study aims to:

  • Determine the effect of multisensory motor imagery training on muscle performance including (peak torque, work, power) of trunk and knee flexors and extensors in children with spastic diplegia.
  • Determine the effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia. BACKGROUND: Multisensory motor imagery training has an effect on muscle performance and coordination in children with spastic diplegia HYPOTHESES: There will be no effect of multisensory motor imagery training on muscle performance, coordination and strength and agility in children with spastic diplegic CP. RESEARCH QUESTION: Is there an effect of multisensory motor imagery training on coordination, strength and agility in children with spastic diplegia?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

November 16, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

September 9, 2024

Last Update Submit

February 15, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • muscle performance

    muscle performance of knee and trunk muscles will be assessed by Isokinetic dynamometer

    through study completion average 3 months

  • coordination

    coordination ill be assessed using BOT-2

    through study completion average 3 months

Study Arms (2)

control

SHAM COMPARATOR

traditional physical therapy program

Other: traditional physical therapy

motor imagery

EXPERIMENTAL

multisensory motor imagery training plus the traditional physical therapy program

Other: motor imagery trainingOther: traditional physical therapy

Interventions

Children in the study group will receive multisensory motor imagery training program 45 minutes. The training protocol consists of several parts that will be run through every training session according to Kumar et al. (2016): * Watching videos of selected multisensory motor skills for 10 minutes. * Mental rehearsal of these motor skills 10 minutes. * Overt practice of the multisensory motor skills for 25 minutes. On the videos, the performance of the skill by a child aged 8-12 years will be shown. All the exercises will be looped to repeat for six to seven times. While projecting the video on the laptop screen, it will be ensured that the children are in a comfortable seating position and the screen is in their visual field. Repetition of the exercises was based on their ability which could be a minimum of five repetitions per session to a maximum of ten repetitions per exercise session.

Also known as: mental rehearsal exercises
motor imagery

traditional physical therapy training program

controlmotor imagery

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Their age will be ranged from 8-12 years.
  • Mild degree of spasticity ranged from 1 to 1+ according to Modified Ashworth Scale
  • Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS
  • They will be able to follow instructions during evaluation and treatment.

You may not qualify if:

  • \- Cardiovascular or respiratory disorders.
  • Botulinium muscular injection in the last 6 months
  • Surgical interference in lower limbs and/or spine.
  • Muscloskeletal problems or fixed deformities in the spine and/or lower extremities.
  • Seizures.
  • Visual or hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayada Elshahawy

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effect of multisensory motor imagery training on muscle performance and coordination in children with spastic diplegia

Study Record Dates

First Submitted

September 9, 2024

First Posted

November 6, 2024

Study Start

November 16, 2024

Primary Completion

February 1, 2025

Study Completion

May 1, 2025

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations