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Utilization of Motor Imagery Training for Improvement of Balance of Ataxic Children After Medulloblastoma Resection

Primary Purpose

Cerebellar Ataxia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
motor imaginary training
physical therapy training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebellar Ataxia

Eligibility Criteria

7 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Reham Alsakhawi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

physical thertapy training

motor imaginary training

Arm Description

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

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

Outcomes

Primary Outcome Measures

Severity of ataxia
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.
Pediatric berg balance scale
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.
Kinematic gait assessment
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.

Secondary Outcome Measures

Full Information

First Posted
July 19, 2023
Last Updated
August 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05992207
Brief Title
Utilization of Motor Imagery Training for Improvement of Balance of Ataxic Children After Medulloblastoma Resection
Official Title
Motor Imagery Training for Improvement of Balance of Ataxic Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2023 (Actual)
Primary Completion Date
May 18, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebellar Ataxia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physical thertapy training
Arm Type
Active Comparator
Arm Description
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
Arm Title
motor imaginary training
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
motor imaginary training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
physical therapy training
Intervention Description
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
Primary Outcome Measure Information:
Title
Severity of ataxia
Description
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.
Time Frame
3 months
Title
Pediatric berg balance scale
Description
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.
Time Frame
3 months
Title
Kinematic gait assessment
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham Alsakhawi
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reham Alsakhawi
City
Giza
ZIP/Postal Code
11236
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Utilization of Motor Imagery Training for Improvement of Balance of Ataxic Children After Medulloblastoma Resection

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