Cerebellar AtaxiaNCT04790981
Effect of Motor Imagery Training on Ataxic Children After Medulloblastoma Resection
A study testing motor imaginary training and physical thertapy training in people with Cerebellar Ataxia, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Cerebellar Ataxia
- What is being tested?
- motor imaginary training and physical thertapy training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Oct 2020to 2 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- medically unstable
- visual impairment
- increased intracranial pressure
- any other neuromuscular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebellar Ataxia
- Being tested
- motor imaginary training, physical thertapy training
- Medical subject headings
- Cerebellar Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor imaginary trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: motor imaginary training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start21 Oct 2020
- Primary completion1 Jan 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar AtaxiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Saeed Alsakhawi, Cairo University
- Investigators
- Reham Alsakhawi, Ph.D., Principal investigator, Assistant Professor, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790981
- Sponsor's protocol ID
- P.T.REC/ 012/001935
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data from participants will be made available
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Imagery Training is an Effective Rehabilitation Program in Treatment of Children With Cerebellar Mutism
- ClinicalTrials.gov ID
- NCT04790981
- Acronym / sponsor ID
- P.T.REC/ 012/001935
- Conditions
- Cerebellar Ataxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| selected physical therapy program group | Active comparator | Other: physical thertapy trainingThe 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 |
| motor imaginary training and selected physical therapy program group | Active comparator | Other: motor imaginary trainingThe 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 |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- medically unstable
- visual impairment
- increased intracranial pressure
- any other neuromuscular diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motor imaginary trainingEach 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 and selected physical therapy program group |
| physical thertapy trainingThe 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. | Other | selected physical therapy program group |
Primary outcome
Severity of ataxia
Time frame: 3 months
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
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.
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: Yes. data from participants will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham Alsakhawi, Ph.D. principal investigator
Assistant Professor, Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor imaginary training and physical thertapy training in people with Cerebellar Ataxia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of ataxia (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.