NCT04790981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

February 26, 2021

Last Update Submit

March 19, 2021

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

selected physical therapy program group

ACTIVE COMPARATOR

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

Other: physical thertapy training

motor imaginary training and selected physical therapy program group

ACTIVE COMPARATOR

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

Other: motor imaginary training

Interventions

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.

motor imaginary training and 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 including.

selected physical therapy program group

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • medically unstable
  • visual impairment
  • increased intracranial pressure
  • any other neuromuscular diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, Egypt

Location

MeSH Terms

Conditions

Cerebellar Ataxia

Condition Hierarchy (Ancestors)

Cerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAtaxiaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Reham Alsakhawi, Ph.D.

    Assistant Professor, Faculty of Physical Therapy, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 10, 2021

Study Start

October 21, 2020

Primary Completion

January 1, 2021

Study Completion

February 2, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

data from participants will be made available

Shared Documents
STUDY PROTOCOL
Time Frame
12 months after study completion
Access Criteria
data access requests will be reviewed by an external independent review panel. requestor will be required to sign a data access agreement

Locations