- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04790981
Effect of Motor Imagery Training on Ataxic Children After Medulloblastoma Resection
Motor Imagery Training is an Effective Rehabilitation Program in Treatment of Children With Cerebellar Mutism
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Giza, Egypt
- Faculty of physical therapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: selected physical therapy program group
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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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.
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ACTIVE_COMPARATOR: motor imaginary training and selected physical therapy program group
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 |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of ataxia
Time Frame: 3 months
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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)
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3 months
|
Pediatric berg balance scale
Time Frame: 3 months
|
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.
|
3 months
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step length (cm)
Time Frame: 3 months
|
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
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3 months
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step width (cm)
Time Frame: 3 months
|
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
|
3 months
|
foot angle (degree)
Time Frame: 3 months
|
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
|
3 months
|
Cadence (steps/min)
Time Frame: 3 months
|
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
|
3 months
|
Gait velocity (cm/sec)
Time Frame: 3 months
|
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
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Reham Alsakhawi, Ph.D., Assistant Professor, Faculty of Physical Therapy, Cairo University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/ 012/001935
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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