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Effect of Motor Imagery Training on Ataxic Children After Medulloblastoma Resection

Primary Purpose

Cerebellar Ataxia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
motor imaginary training
physical thertapy 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

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

selected physical therapy program group

motor imaginary training and selected physical therapy program group

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 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

Outcomes

Primary Outcome Measures

Severity of ataxia
Scale for the Assessment and Rating of Ataxia to determine the degree of ataxia. It has eight items that yield a total score of 0 (no ataxia) to 40 (most severe ataxia)
Pediatric berg balance scale
to assess balance all children were assessed by the 14 items of the scale including sitting to standing, standing to sitting, transfers, standing unsupported, sitting unsupported, stand with eye closed, stand with feet together, standing with one foot in front, standing on one foot, turning 360 degrees, turning to look behind, retrieving object from floor, placing alternate foot on stool, and reaching forward without stretched arm. The total scale score range from 0 to 56.
step length (cm)
Kinematic gait analysis: Temporo-spatial gait variables were measured using a 2D motion analysis system. The kin markers were placed at greater trochanter, lateral femoral epicondyle, lateral malleolus and 5th metatarsal head. The tripod fixed with a video camera placed at 3 meters away from the walkway and focused on the middle part to record around 3 gait cycles of sagittal plane motion. The Kinovea software version 8.15.0 used to measure step length, stride length, cadence and walking speed. The measurement involved one trial of walking at the preferred gait speed along the 4 meters walkway
step width (cm)
Kinematic gait analysis: Temporo-spatial gait variables were measured using a 2D motion analysis system. The kin markers were placed at greater trochanter, lateral femoral epicondyle, lateral malleolus and 5th metatarsal head. The tripod fixed with a video camera placed at 3 meters away from the walkway and focused on the middle part to record around 3 gait cycles of sagittal plane motion. The Kinovea software version 8.15.0 used to measure step length, stride length, cadence and walking speed. The measurement involved one trial of walking at the preferred gait speed along the 4 meters walkway
foot angle (degree)
Kinematic gait analysis: Temporo-spatial gait variables were measured using a 2D motion analysis system. The kin markers were placed at greater trochanter, lateral femoral epicondyle, lateral malleolus and 5th metatarsal head. The tripod fixed with a video camera placed at 3 meters away from the walkway and focused on the middle part to record around 3 gait cycles of sagittal plane motion. The Kinovea software version 8.15.0 used to measure step length, stride length, cadence and walking speed. The measurement involved one trial of walking at the preferred gait speed along the 4 meters walkway
Cadence (steps/min)
Kinematic gait analysis: Temporo-spatial gait variables were measured using a 2D motion analysis system. The kin markers were placed at greater trochanter, lateral femoral epicondyle, lateral malleolus and 5th metatarsal head. The tripod fixed with a video camera placed at 3 meters away from the walkway and focused on the middle part to record around 3 gait cycles of sagittal plane motion. The Kinovea software version 8.15.0 used to measure step length, stride length, cadence and walking speed. The measurement involved one trial of walking at the preferred gait speed along the 4 meters walkway
Gait velocity (cm/sec)
Kinematic gait analysis: Temporo-spatial gait variables were measured using a 2D motion analysis system. The kin markers were placed at greater trochanter, lateral femoral epicondyle, lateral malleolus and 5th metatarsal head. The tripod fixed with a video camera placed at 3 meters away from the walkway and focused on the middle part to record around 3 gait cycles of sagittal plane motion. The Kinovea software version 8.15.0 used to measure step length, stride length, cadence and walking speed. The measurement involved one trial of walking at the preferred gait speed along the 4 meters walkway

Secondary Outcome Measures

Full Information

First Posted
February 26, 2021
Last Updated
March 19, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04790981
Brief Title
Effect of Motor Imagery Training on Ataxic Children After Medulloblastoma Resection
Official Title
Motor Imagery Training is an Effective Rehabilitation Program in Treatment of Children With Cerebellar Mutism
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
February 2, 2021 (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
selected physical therapy program group
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 and selected physical therapy program group
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 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)
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 thertapy training
Intervention 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 including.
Primary Outcome Measure Information:
Title
Severity of ataxia
Description
Scale for the Assessment and Rating of Ataxia to determine the degree of ataxia. It has eight items that yield a total score of 0 (no ataxia) to 40 (most severe ataxia)
Time Frame
3 months
Title
Pediatric berg balance scale
Description
to assess balance all children were assessed by the 14 items of the scale including sitting to standing, standing to sitting, transfers, standing unsupported, sitting unsupported, stand with eye closed, stand with feet together, standing with one foot in front, standing on one foot, turning 360 degrees, turning to look behind, retrieving object from floor, placing alternate foot on stool, and reaching forward without stretched arm. The total scale score range from 0 to 56.
Time Frame
3 months
Title
step length (cm)
Description
Kinematic gait analysis: Temporo-spatial gait variables were measured using a 2D motion analysis system. The kin markers were placed at greater trochanter, lateral femoral epicondyle, lateral malleolus and 5th metatarsal head. The tripod fixed with a video camera placed at 3 meters away from the walkway and focused on the middle part to record around 3 gait cycles of sagittal plane motion. The Kinovea software version 8.15.0 used to measure step length, stride length, cadence and walking speed. The measurement involved one trial of walking at the preferred gait speed along the 4 meters walkway
Time Frame
3 months
Title
step width (cm)
Description
Kinematic gait analysis: Temporo-spatial gait variables were measured using a 2D motion analysis system. The kin markers were placed at greater trochanter, lateral femoral epicondyle, lateral malleolus and 5th metatarsal head. The tripod fixed with a video camera placed at 3 meters away from the walkway and focused on the middle part to record around 3 gait cycles of sagittal plane motion. The Kinovea software version 8.15.0 used to measure step length, stride length, cadence and walking speed. The measurement involved one trial of walking at the preferred gait speed along the 4 meters walkway
Time Frame
3 months
Title
foot angle (degree)
Description
Kinematic gait analysis: Temporo-spatial gait variables were measured using a 2D motion analysis system. The kin markers were placed at greater trochanter, lateral femoral epicondyle, lateral malleolus and 5th metatarsal head. The tripod fixed with a video camera placed at 3 meters away from the walkway and focused on the middle part to record around 3 gait cycles of sagittal plane motion. The Kinovea software version 8.15.0 used to measure step length, stride length, cadence and walking speed. The measurement involved one trial of walking at the preferred gait speed along the 4 meters walkway
Time Frame
3 months
Title
Cadence (steps/min)
Description
Kinematic gait analysis: Temporo-spatial gait variables were measured using a 2D motion analysis system. The kin markers were placed at greater trochanter, lateral femoral epicondyle, lateral malleolus and 5th metatarsal head. The tripod fixed with a video camera placed at 3 meters away from the walkway and focused on the middle part to record around 3 gait cycles of sagittal plane motion. The Kinovea software version 8.15.0 used to measure step length, stride length, cadence and walking speed. The measurement involved one trial of walking at the preferred gait speed along the 4 meters walkway
Time Frame
3 months
Title
Gait velocity (cm/sec)
Description
Kinematic gait analysis: Temporo-spatial gait variables were measured using a 2D motion analysis system. The kin markers were placed at greater trochanter, lateral femoral epicondyle, lateral malleolus and 5th metatarsal head. The tripod fixed with a video camera placed at 3 meters away from the walkway and focused on the middle part to record around 3 gait cycles of sagittal plane motion. The Kinovea software version 8.15.0 used to measure step length, stride length, cadence and walking speed. The measurement involved one trial of walking at the preferred gait speed along the 4 meters 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, Ph.D.
Organizational Affiliation
Assistant Professor, Faculty of Physical Therapy, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
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

Effect of Motor Imagery Training on Ataxic Children After Medulloblastoma Resection

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