NCT05992207

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 Jan 2023

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

January 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

July 19, 2023

Last Update Submit

August 7, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    3 months

  • 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.

    3 months

  • 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.

    3 months

Study Arms (2)

physical thertapy training

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 therapy training

motor imaginary training

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 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

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

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

physical thertapy training

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)

Reham Alsakhawi

Giza, 11236, Egypt

Location

Related Publications (1)

  • Alsakhawi RS, Elshafey MA, Alkhouli MN. Utilization of Motor Imagery Training for Improvement of Balance of Ataxic Children after Medulloblastoma Resection. Sci Rep. 2024 Nov 27;14(1):29500. doi: 10.1038/s41598-024-78900-7.

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

    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
Assisstant Professor

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 15, 2023

Study Start

January 21, 2023

Primary Completion

May 18, 2023

Study Completion

June 30, 2023

Last Updated

August 15, 2023

Record last verified: 2023-08

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