NCT04765917

Brief Summary

This study aims to:

  • Investigate the effect of motor imagery training on gait kinematics in children with spastic hemiplegia.
  • Determine the effect of motor imagery training on balance in children with spastic hemiplegia.
  • Assess the effect of motor imagery training on trunk endurance in children with spastic hemiplegia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

February 16, 2021

Last Update Submit

April 11, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Assessing the change in Spatial parameters of gait

    Analysis of Spatial parameters of gait by using Kinovea software via 2D gait analysis in order to measure the changes in: stride length (cm), Step length (cm).

    "through study completion, an average of 3 months"

  • Assessing the change in cadence

    Analysis of temporal parameters of gait by using Kinovea software via 2D gait analysis in order to measure the changes in: cadence (number of steps / minute).

    "through study completion, an average of 3 months"

  • Assessing the change in Angular displacement of joint in gait cycle

    Analysis of Angular displacement of joint in gait cycle by using Kinovea software via 2D gait analysis in order to measure the changes in: Ankle dorsiflexion angle in initial contact, hip flexion angle at initial swing and knee extension at midstance. All of these parameters will be measured in degrees.

    "through study completion, an average of 3 months"

  • Assessing the change in Balance

    Evaluation of balance by using HUMAC balance system in order to measure the change in: modified clinical test of sensory integration test (score), limits of stability (score) and weight shift (score). The highest score is (100) and the lower score is (0). The higher scores means a better outcome.

    "through study completion, an average of 3 months"

  • Assessing the change in walking speed

    Analysis of temporal parameters of gait by using Kinovea software via 2D gait analysis in order to measure the changes in: walking speed (meter / minute).

    "through study completion, an average of 3 months"

Secondary Outcomes (1)

  • Assessing the change in Trunk muscles endurance

    "through study completion, an average of 3 months"

Study Arms (2)

Selected Physical Therapy group

ACTIVE COMPARATOR

The Control group will receive a selected physical therapy program for 60 minutes, 3 times/week for 3 successive months including the following exercises

Other: Selected physical Therapy program

Motor imagery training

EXPERIMENTAL

Children allocated to the study group will receive the same selected physical therapy program given to the control group for 30 min in addition to 30 minutes motor imagery training program

Other: Selected physical Therapy programOther: Motor imagery training program

Interventions

-Facilitation of balance reactions from standing position including: Standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing, standing on balance board and pushing the child in different directions. * Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands. * Strengthening exercises for weakened muscles in upper and lower limbs muscle. * Strengthening exercises for back and abdominal muscles. * Stretching exercises for tight muscles in upper and lower limbs. * Gait training activities for correction of gait pattern including: walking on balance beam, walking on balance board, walking on uneven surface, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs. * Jumping in place and jumping a board.

Motor imagery trainingSelected Physical Therapy group

As a preparation each child will be shown a video of 5 minutes of normal movements. They will be positioned in a comfortable position. The screen is in the child's visual field. Children will be asked to close their eyes and imagine they will perform the physically practiced task for 10 minutes, similar to one shown in the video. Sequence of the task will be verbally explained to the child for better recalling of sensations in muscles during the movements. During the entire exercise schedule child's attention will be focused on the position, and movement of their body, on proprioceptive inputs coming from the leg muscles and on the tactile sensations of foot floor contact. Thereafter, the child will be asked to perform the sequence of tasks, rehearsed mentally for 20 minutes.

Motor imagery training

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Their chronological age will be ranged from 7-10 years.
  • Their motor function will be at level I according to according to Gross Motor Function Classification System GMFCS (Palisano et al., 2008).
  • The degree of spasticity for these children will ranged from grade 1 to 1+ according to Modified Ashworth Scale (Bohannon and Smith, 1987).
  • They will be able to follow instructions during evaluation and treatment.

You may not qualify if:

  • Children will be excluded from the study if they have:
  • Cardiovascular or respiratory disorders.
  • Botulinium muscular injection in the last 6 months
  • Surgical interference in lower limbs.
  • Musculoskeletal problems or fixed deformities in the spine and/or lower extremities.
  • Seizures.
  • Visual or hearing impairment.
  • Mentally retarded children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy - Cairo University

Cairo, 12316, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 different groups receive different interventions at the same time during the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 23, 2021

Study Start

February 1, 2021

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

April 13, 2021

Record last verified: 2021-04

Locations