- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05992207
Utilization of Motor Imagery Training for Improvement of Balance of Ataxic Children After Medulloblastoma Resection
August 7, 2023 updated by: Reham Saeed Alsakhawi, Cairo University
Motor Imagery Training for Improvement of Balance of Ataxic Children
Background: after resection of medulloblastoma in children they suffer from signs and symptoms of ataxia which impedes their activities of daily living.
purpose: to investigate the effect motor imagery training on balance, severity of ataxia and gait parameters on children after resection of medulloblastoma.
Methods: Fifty children surfing from cerebellar ataxia after medulloblastoma resection were selected from tumors hospital of Cairo University, their age ranged from seven to nine years old, they were randomly assigned into two matched control and study groups.
The control groups received the selected physical therapy program while, the study group received motor imaginary training in addition to the selected physical therapy program.
Both groups were evaluated by ataxic rating scale, pediatric berg balance scale and kinematic gait analysis by kinovea software.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Motor imagery is an effective method to enhance motor performance applied in rehabilitation programs it did not impose a physical load on patients, was confirmed through clinical evidence from meta#analysis.
Motor imagery means thinking in motor task with executing it to activate motor cortical areas as 25% of the brain neurons are mirror neurons and fire by thinking.
Study Type
Interventional
Enrollment (Actual)
50
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
-
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Giza, Egypt, 11236
- Reham Alsakhawi
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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
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The children had signs of ataxia
- loss of balance
- able to understand and execute test instructions
- the children are in the follow up period after medulloblastoma resection
Exclusion Criteria:
- medically unstable
- visual impairment
- increased intracranial pressure
- any other neuromuscular diseases.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: physical thertapy training
The Control group received the selected physical therapy program for one hour, three times weekly for three successive months including facilitation of balance and protective reactions from standing position, standing on one leg, weight shifting from standing, squat to standing, strengthening exercises for trunk muscles and for upper and lower extremities musculatures, gait training activities for correction of gait pattern
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facilitation of balance and protective reactions from standing position, standing on one leg, weight shifting from standing, squat to standing, strengthening exercises for trunk muscles and for upper and lower extremities musculatures, gait training activities for correction of gait pattern
|
|
Active Comparator: motor imaginary training
The study group received the selected physical therapy program for one hour, three times weekly for three successive months in addition to motor imagery program for 30 minutes as the following.
Each child shown a video of 5 minutes of illustrating normal movements while the child resting in semireclined sitting in quiet room in front the screen.
Children then asked to close their eyes and imagine practicing the task like the illustrative video.
Repetition of the exercises depend on the children ranging from 5 to 10 repetitions per exercise
|
Each child shown a video of 5 minutes of illustrating normal movements while the child resting in semi#reclined sitting in quiet room in front the screen.
Children then asked to close their eyes and imagine practicing the task like the illustrative video.
Repetition of the exercises depend on the children ranging from 5 to 10 repetitions per exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of ataxia
Time Frame: 3 months
|
The SARA determines the degree of ataxia.
It has eight items with a score range of 0 (means no ataxia) to 40 (means severe ataxia).
It contains sitting, stance, gait, limb kinetic functions, heel-shin slide, fast alternating hand movements, nose-finger test, finger chase, and speech disturbance.
The arithmetic means of the left and right sides and independent ratings of each side are included in the SARA total score.
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3 months
|
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Pediatric berg balance scale
Time Frame: 3 months
|
The Paediatric Berg Balance Scale assesses children's balance.
The scale includes 14 items: sit to stand, stand to sit, transfers, stand unsupported, sit unsupported, stand with eyes closed, stand with feet together, stand with one foot in front of the other, stand on one foot, turn 360 degrees, turn to look behind, retrieve an object from the floor, place an alternating foot on a stool, and reach forward with an outstretched arm.
The total scale score ranges from zero to 56.
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3 months
|
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Kinematic gait assessment
Time Frame: 3 months
|
Kinematic gait analysis measured temporospatial gait variables using a two-dimensional motion analysis system.
Markers were placed on the skin overlying the lateral femoral epicondyle, greater trochanter, 5th metatarsal head, and lateral malleolus.
The therapist set a tripod with a fixed video camera at 3 m from the walkway.
The fixed video camera was concentrated on the central part to record three gait cycles in the sagittal plane.
The therapist used the Kinovea software (version 8.15.0) to measure stride length, step length, cadence, and walking speed.
The measurement involved one walking trial at the chosen speed throughout the 4-m walkway.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Reham Alsakhawi, Cairo university
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)
January 21, 2023
Primary Completion (Actual)
May 18, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
July 19, 2023
First Submitted That Met QC Criteria
August 7, 2023
First Posted (Actual)
August 15, 2023
Study Record Updates
Last Update Posted (Actual)
August 15, 2023
Last Update Submitted That Met QC Criteria
August 7, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/ 012/004454
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
data from participants will be made available
IPD Sharing Time Frame
12 months after study completion
IPD Sharing Access Criteria
data access requests will be reviewed by an external independent review panel.
requestor will be required to sign a data access agreement
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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