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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04790981
Other study ID # P.T.REC/ 012/001935
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2020
Est. completion date February 2, 2021

Study information

Verified date March 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 2, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 7 Years to 9 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
motor imaginary training
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.
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 including.

Locations

Country Name City State
Egypt Faculty of Physical Therapy Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 3 months
Primary 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. 3 months
Primary 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 3 months
Primary 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 3 months
Primary 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 3 months
Primary 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 3 months
Primary 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 3 months
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