Medulloblastoma, ChildhoodNCT04860934
Dual Task Training On Children With Ataxia After Medulloblastoma Resection
A study testing Dual Task Training Program Group in people with Medulloblastoma, Childhood and Childhood Cancer, run by Children's Cancer Hospital Egypt 57357 at 1 site in Egypt.
Trial summary
Medulloblastoma is a rapidly-growing tumor of the cerebellum, this area controls balance, posture and sophisticated motor functions like finer hand movements, speech, and swallowing. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Medulloblastoma, Childhood, Childhood Cancer
- What is being tested?
- Dual Task Training Program Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2021to 30 Nov 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range from (5-10 years).
- Severity of ataxia will be from 15-30 by SARA scale.
- Children after 2 months of medulloblastoma resection.
- They can stand and walk with minimal support.
- They have good cognition, compliance, and ability to understand and execute test instructions.
- Children receiving radiotherapy and chemotherapy sessions
- They are medically stable
Who cannot join
- Children will be excluded from the study if they have
- Any neuromuscular disorder.
- Visual impairment.
- Cognitive problem
- Convulsion.
- Peripheral neuropathy due to chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Of Dual Task Training On Children With Ataxia After Medulloblastoma Resection
Medulloblastoma is a rapidly-growing tumor of the cerebellum, this area controls balance, posture and sophisticated motor functions like finer hand movements, speech, and swallowing. With the goal of, complete resection, major complications during tumor removal are usually caused by damage to the brain stem and injury to the lower cranial nerves.It has been reported that those children present Ataxia after resection. So the purpose of this study is to investigate the effectiveness of using a selected dual-task- training program to improve postural stability in those Children.
Read the detailed description
Most patients present with symptoms of hydrocephalus due to obstruction by tumor at the level of the fourth ventricle or cerebral aqueduct, and ataxia (Martin et al., 2014). If the tumor is large enough, the lesion itself can also cause mass effect and increased intracranial pressure. Furthermore, direct structural damage from the children can thus present with nausea, vomiting, ataxia,diplopia.
Ataxia in children is a common clinical sign of various origins consisting of impaired coordination of movement and balance with a lack of muscle control during voluntary activity. Ataxia is most frequently caused by dysfunction of the complex circuitry connecting the basal ganglia, cerebellum and cerebral cortex, and this type of involvement is recorded as "cerebellar ataxia.
Recently, the evidence for procedural memory training has advanced sophistication to suggest and ultimately prove that automaticity of a primary (motor task can be developed through exposure to massive repetitions practice) and the forced subconscious processing using dual task interference (Bermúdez, 2017).
The Objectives of the Study:
1- Aim of the Study: Determining the efficacy of "Dual Task Training in children with ataxia after Medulloblastoma Resection regarding "Static Balance" and "Dynamic Balance" as indicators of Postural Control
2-Specific Objectives:
- Assess static balance by measuring center of pressure using force plate mode in the humac balance system.
- Assess dynamic balance by using tilt mode in the humac balance system .
- Evaluate the improvement on functional status and independence in ADL activities by functional independence measurement.
- Determine the more effective program for rehabilitation of children with ataxia
3-Secondary Objectives:
- Assess the degree of ataxia in children after medulloblastoma resection by SARA scale.
- Detect the effect of cognitive interference on postural stability and balance.
- Detect if there is improvement in cognitve function after dual task training.
- Conditions
- Medulloblastoma, Childhood, Childhood Cancer
- Being tested
- Dual Task Training Program Group, Control Group
- Keywords
- Ataxia, Medulloblastoma Resection, posterior fossa tumor, physical activity, Dual Task Training, Childhood Cancer
- Medical subject headings
- Medulloblastoma, Neoplasms, Ataxia, Infratentorial Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Task Training Program GroupBehavioural
Fifteen patients will receive Dual Task Training Program. Total Period: 8 Weeks.
Control GroupBehavioural
Each child in this group will receive the selected physical therapy program which include mobility exercises, strengthening exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning for one-hour session three times weekly for 8 successive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy | Active comparator | Each child in this group will receive the selected physical therapy program which include mobility exercises, strengthening exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning for one-hour session three times weekly for 8 successive weeks Receives: Behavioral: Control Group |
| Physical therapy + Dual Task Training Program | Experimental | Each child in this group will perform one-hour session consist of two tasks (cognitive and balance task) in addition to the selected physical therapy program as control group three times weekly for 8 successive weeks. Receives: Behavioral: Dual Task Training Program Group; Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual Task Training program
Determining the efficacy of "Dual-Task Training in children with ataxia after Medulloblastoma Resection regarding "Static Balance" and "Dynamic Balance" will be assessed with HUMAC Balance system as indicators of Postural Control
Measured: 8 Weeks
Secondary outcomes (1)
Ataxia after Medulloblastoma Resection
The degree of ataxia will be assessed in children by SARA (Scale of Assessment and Rating of Ataxia) with a scoring scale with minimum value (0, which means there is no Ataxia) and maximum values (40, high score of Ataxia).
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start15 Mar 2021
- Primary completion15 Nov 2021
- Study completion30 Nov 2021
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 Medulloblastoma, ChildhoodStudies of the same condition, open and under way.
- 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
- Model description
- Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatma Mostafa Sedeek, BSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860934
- Sponsor's protocol ID
- CCHE-BT004
- Status last verified
- Nov 2022
- First submitted
- 21 Mar 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Selim FM, Elshafey MA, El-Ayadi MM, Albeltagi DM, Ali MS. Efficacy of dual-task training on stability and function in children with ataxia after medulloblastoma resection: A randomized controlled trial. Pediatr Blood Cancer. 2023 Nov;70(11):e30613. doi: 10.1002/pbc.30613. Epub 2023 Aug 10.
PubMed 37561355
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Dual Task Training On Children With Ataxia After Medulloblastoma Resection
- ClinicalTrials.gov ID
- NCT04860934
- Acronym / sponsor ID
- CCHE-BT004
- Conditions
- Medulloblastoma, Childhood, Childhood Cancer
- Keywords
- Ataxia, Medulloblastoma Resection, posterior fossa tumor, physical activity, Dual Task Training, Childhood Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 27 Apr 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.
Medulloblastoma is a rapidly-growing tumor of the cerebellum, this area controls balance, posture and sophisticated motor functions like finer hand movements, speech, and swallowing. With the goal of, complete resection, major complications during tumor removal are usually caused by damage to the brain stem and injury to the lower cranial nerves.It has been reported that those children present Ataxia after resection. So the purpose of this study is to investigate the effectiveness of using a selected dual-task- training program to improve postural stability in those Children.
Detailed description
Most patients present with symptoms of hydrocephalus due to obstruction by tumor at the level of the fourth ventricle or cerebral aqueduct, and ataxia (Martin et al., 2014). If the tumor is large enough, the lesion itself can also cause mass effect and increased intracranial pressure. Furthermore, direct structural damage from the children can thus present with nausea, vomiting, ataxia,diplopia.
Ataxia in children is a common clinical sign of various origins consisting of impaired coordination of movement and balance with a lack of muscle control during voluntary activity. Ataxia is most frequently caused by dysfunction of the complex circuitry connecting the basal ganglia, cerebellum and cerebral cortex, and this type of involvement is recorded as "cerebellar ataxia.
Recently, the evidence for procedural memory training has advanced sophistication to suggest and ultimately prove that automaticity of a primary (motor task can be developed through exposure to massive repetitions practice) and the forced subconscious processing using dual task interference (Bermúdez, 2017).
The Objectives of the Study:
1- Aim of the Study: Determining the efficacy of "Dual Task Training in children with ataxia after Medulloblastoma Resection regarding "Static Balance" and "Dynamic Balance" as indicators of Postural Control
2-Specific Objectives:
- Assess static balance by measuring center of pressure using force plate mode in the humac balance system.
- Assess dynamic balance by using tilt mode in the humac balance system .
- Evaluate the improvement on functional status and independence in ADL activities by functional independence measurement.
- Determine the more effective program for rehabilitation of children with ataxia
3-Secondary Objectives:
- Assess the degree of ataxia in children after medulloblastoma resection by SARA scale.
- Detect the effect of cognitive interference on postural stability and balance.
- Detect if there is improvement in cognitve function after dual task training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
| Arm | Type | Receives |
|---|---|---|
| Physical therapy | Active comparator | Behavioral: Control GroupEach child in this group will receive the selected physical therapy program which include mobility exercises, strengthening exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning for one-hour session three times weekly for 8 successive weeks |
| Physical therapy + Dual Task Training Program | Experimental | Behavioral: Dual Task Training Program Group, Behavioral: Control GroupEach child in this group will perform one-hour session consist of two tasks (cognitive and balance task) in addition to the selected physical therapy program as control group three times weekly for 8 successive weeks. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age range from (5-10 years).
- Severity of ataxia will be from 15-30 by SARA scale.
- Children after 2 months of medulloblastoma resection.
- They can stand and walk with minimal support.
- They have good cognition, compliance, and ability to understand and execute test instructions.
Key exclusion criteria (6 listed)
- Children will be excluded from the study if they have
- Any neuromuscular disorder.
- Visual impairment.
- Cognitive problem
- Convulsion.
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 |
|---|---|---|
| Dual Task Training Program GroupFifteen patients will receive Dual Task Training Program. Total Period: 8 Weeks. | Behavioural | Physical therapy + Dual Task Training Program |
| Control GroupEach child in this group will receive the selected physical therapy program which include mobility exercises, strengthening exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning for one-hour session three times weekly for 8 successive weeks. | Behavioural | Physical therapy, Physical therapy + Dual Task Training Program |
Primary outcome
Dual Task Training program
Time frame: 8 Weeks
Determining the efficacy of "Dual-Task Training in children with ataxia after Medulloblastoma Resection regarding "Static Balance" and "Dynamic Balance" will be assessed with HUMAC Balance system as indicators of Postural Control
1 secondary outcome
Ataxia after Medulloblastoma Resection
Time frame: 8 Weeks
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 8 Nov 2022.
- Derived from this study: PubMed 37561355Selim FM, Elshafey MA, El-Ayadi MM, Albeltagi DM, Ali MS. Efficacy of dual-task training on stability and function in children with ataxia after medulloblastoma resection: A randomized controlled trial. Pediatr Blood Cancer. 2023 Nov;70(11):e30613. doi: 10.1002/pbc.30613. Epub 2023 Aug 10.
Related trials for Medulloblastoma, Childhood
RecruitingEarly Phase 1
Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
CNS Embryonal Tumor, CNS, Medulloblastoma
RecruitingPhase 1
Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
Ependymoma, Medulloblastoma
Active, not recruitingPhase 2
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
Glioblastoma, Medulloblastoma
Active, not recruitingPhase 2
Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma
Brain and Central Nervous System Tumors
Active, not recruitingPhase 2
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma
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.
Fatma Mostafa Sedeek, BSc 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 Dual Task Training Program Group in people with Medulloblastoma, Childhood and Childhood Cancer, run by Children's Cancer Hospital Egypt 57357 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 7 inclusion and 6 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 8 Nov 2022. 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?
Dual Task Training program (time frame: 8 Weeks). 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 NCT04860934, 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 8 Nov 2022.