Cerebellar AtaxiaNCT05992207
Utilization of Motor Imagery Training for Improvement of Balance of Ataxic Children After Medulloblastoma Resection
A study testing motor imaginary training and physical therapy 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 therapy training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jan 2023to 30 Jun 2023
- 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 for Improvement of Balance of Ataxic Children
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 therapy 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 therapy trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 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
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.
Measured: 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.
Measured: 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.
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 posted15 Aug 2023
- Study start21 Jan 2023
- Primary completion18 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992207
- Sponsor's protocol ID
- P.T.REC/ 012/004454
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data from participants will be made available
Publications
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.
PubMed 39604382
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Imagery Training for Improvement of Balance of Ataxic Children
- ClinicalTrials.gov ID
- NCT05992207
- Acronym / sponsor ID
- P.T.REC/ 012/004454
- Conditions
- Cerebellar Ataxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 15 Aug 2023 (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 |
|---|---|---|
| physical thertapy training | Active comparator | Other: physical therapy 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 | 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 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 |
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 |
| physical therapy trainingfacilitation 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 |
Primary outcome
Severity of ataxia
Time frame: 3 months
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.
Pediatric berg balance scale
Time frame: 3 months
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.
Kinematic gait assessment
Time frame: 3 months
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.
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 15 Aug 2023.
- Derived from this study: PubMed 39604382Alsakhawi 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.
- 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 principal investigator
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 therapy 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 15 Aug 2023. 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 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05992207, which also lists 1 linked publication.
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 15 Aug 2023.