Posterior Fossa TumorNCT04528316
Physical Activity on Postural Stability and Coordination in Children With Posterior Fossa Tumor
A study testing Pilates Core Stability Exercises program, Balance Program and Coordination in people with Posterior Fossa Tumor and Medulloblastoma, Childhood, 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 12 years
- Conditions the study is for
- Posterior Fossa Tumor, Medulloblastoma, Childhood
- What is being tested?
- Pilates Core Stability Exercises program, Balance Program and Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Aug 2020to 30 Apr 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with posterior fossa tumors during follow up.
- Children between 5-12 years old.
- Time elapsed since the start of treatment more than 4 months in order to be in maintenance phase.
- They can understand verbal command.
- Children with no visual, auditory or perceptual disorders.
- Children are already treated surgically.
Who cannot join
- Children who have one or more of the following criteria will be excluded from the study:
- Children with a genetic disorder or mental retardation.
- Children with a chronic lung disease.
- Sever cardiomyopathy (ejection fraction <40%, ischemia and angina pectoris at rest).
- Children with a neuromuscular disease not related to tumor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Physical Activity on Postural Stability and Coordination in Children With Posterior Fossa Tumor
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. It has been reported that those children fall frequently so the purpose of this study is to investigate the effectiveness of balance and coordination training in these Children.
Read the detailed description
The effects of physical exercise training interventions for childhood cancer participants are not yet convincing due to small numbers of participants and insufficient study methodology. More and high-quality evidence is needed in order to be able to draft exercise and physical activity guidelines for this population. Despite the positive results of exercise interventions in adult cancer patients, the evidence for benefits in childhood cancer patients is limited.
There are Two Main objectives:
- To investigate the effectiveness of Pilates core stability exercises program. 2. To investigate the effectiveness of Humac balance and tilt system.
Secondary Objectives:
- The effectiveness of coordination training in children with posterior fossa tumors.
- The comparison between balance and coordination training and which of both trainings has more effect.
This study will take place in a pediatric oncology setting, Children's Cancer Hospital Egypt(CCHE), in outpatient setting. Patients will be evaluated for their balance and coordination at initial presentation, during treatment, and during follow-up after end of treatment at CCHE. Also patients will receive balance and coordination training, before each chemotherapy cycle-maximum one week- given the patient is in good state.
Sixty children with posterior fossa tumors of both sexes will participate in this study. They will be selected from CCHE. They will be randomly assigned into 3 groups of equal number.
- Conditions
- Posterior Fossa Tumor, Medulloblastoma, Childhood
- Being tested
- Pilates Core Stability Exercises program, Balance Program, Coordination
- Keywords
- physical activity, postural stability, coordination, posterior fossa tumor
- Medical subject headings
- Infratentorial Neoplasms, Medulloblastoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates Core Stability Exercises programBehavioural
Twenty patients will receive Pilates core stability exercises program ONLY. Total Period: 12 Weeks
Stages: Three stages:
- Stage I: Warm-up: consists of four Pilates motions:
- Breathing:
- Rolling back:
- Coccyx-curl:
- Hundred breathing:
- Stage II: Work-out: consists of twelve Pilates motions:
- Single leg stretch:
- Straight leg raise:
- Basic bridge:
- Bridging variation:
- Quadruped:
- Clap with seal motion
- Mermaid twist:
- Swimming:
- Double leg stretch:
- Shoulder bridge:
- Swan dive:
- Leg full front:
- Stage III: Cool-down: consists of three Pilates motions:
- Rest position:
- Cat with arm/leg extension:
- Breathing:
Balance ProgramBehavioural
Also called HUMAC program
Total Period: 12 Weeks. The designed HUMAC program will work on the modified clinical test of sensory integration of balance (mCTSIB) with eyes open and with eyes closed, the center of pressure (COP) and the limit of stability test (LOS).
CoordinationBehavioural
Total Period: 12 Weeks. Coordination will be assessed using BOT2, Bilateral coordination (Sub test No.4) composed of 7 items and Upper-Limb coordination (Sub test No.7) composed of 7 items too.
The raw scores are recorded first then it is converted into point scores, then subtest total point score is obtained by adding point scores.
| Study group | Role | What they receive |
|---|---|---|
| Control Group/Pilates Core Stability Exercises program Group | Active comparator | Twenty patients will receive Pilates core stability exercises program ONLY. Total Period: 12 Weeks
Stages: Three stages:
* Stage I: Warm-up: consists of four Pilates motions:
1. Breathing:
2. Rolling back:
3. Coccyx-curl:
4. Hundred breathing:
* Stage II: Work-out: consists of twelve Pilates motions:
1. Single leg stretch:
2. Straight leg raise:
3. Basic bridge:
4. Bridging variation:
5. Quadruped:
6. Clap with seal motion
7. Mermaid twist:
8. Swimming:
9. Double leg stretch:
10. Shoulder bridge:
11. Swan dive:
12. Leg full front:
* Stage III: Cool-down: consists of three Pilates motions:
1. Rest position:
2. Cat with arm/leg extension:
3. Breathing: Receives: Behavioral: Pilates Core Stability Exercises program |
| Balance Group | Experimental | Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Balance Program Receives: Behavioral: Pilates Core Stability Exercises program; Behavioral: Balance Program |
| Coordination Group | Experimental | Twenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Coordination Exercises. Receives: Behavioral: Pilates Core Stability Exercises program; Behavioral: Coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Balance
For assessment of the three groups, HUMAC balance and tilt system will be used to assess both Static and dynamic balance.
Measured: at week 12
Secondary outcomes (1)
Change Coordination
The Bruininks-Oseretsky Test of Motor Proficiency - Second Edition
- The minimum and maximum values: Coordination will be assessed using BOT2, Bilateral coordination (Sub test No.4) composed of 7 items and Upper-Limb coordination (Sub test No.7) composed of 7 items too.
The raw scores are recorded first then it is converted into point scores, then subtest total point score is obtained by adding point scores.
Bilateral Coordination: Total Point Score Subtest (min=Zero, max=24). Upper-Limb Coordination: Total Point Score Subtest (min=Zero, max=39).
- Higher scores mean a better outcome.
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start6 Aug 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 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 Posterior Fossa TumorStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Cancer Hospital Egypt 57357
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud Usama Mahmoud Ahmed, MSc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528316
- Sponsor's protocol ID
- CCHE-BT003
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Usama M, Abdelaziem F, Rashed WM, Maher E, El Beltagy M, Zekri W. Impact of physical activity on postural stability and coordination in children with posterior fossa tumor: randomized control phase III trial. J Cancer Res Clin Oncol. 2023 Aug;149(9):5637-5644. doi: 10.1007/s00432-022-04490-4. Epub 2022 Dec 16.
PubMed 36525069
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Activity on Postural Stability and Coordination in Children With Posterior Fossa Tumor
- ClinicalTrials.gov ID
- NCT04528316
- Acronym / sponsor ID
- CCHE-BT003
- Conditions
- Posterior Fossa Tumor, Medulloblastoma, Childhood
- Keywords
- physical activity, postural stability, coordination, posterior fossa tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Children's Cancer Hospital Egypt 57357University, hospital or other
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 27 Aug 2020 (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. It has been reported that those children fall frequently so the purpose of this study is to investigate the effectiveness of balance and coordination training in these Children.
Detailed description
The effects of physical exercise training interventions for childhood cancer participants are not yet convincing due to small numbers of participants and insufficient study methodology. More and high-quality evidence is needed in order to be able to draft exercise and physical activity guidelines for this population. Despite the positive results of exercise interventions in adult cancer patients, the evidence for benefits in childhood cancer patients is limited.
There are Two Main objectives:
- To investigate the effectiveness of Pilates core stability exercises program. 2. To investigate the effectiveness of Humac balance and tilt system.
Secondary Objectives:
- The effectiveness of coordination training in children with posterior fossa tumors.
- The comparison between balance and coordination training and which of both trainings has more effect.
This study will take place in a pediatric oncology setting, Children's Cancer Hospital Egypt(CCHE), in outpatient setting. Patients will be evaluated for their balance and coordination at initial presentation, during treatment, and during follow-up after end of treatment at CCHE. Also patients will receive balance and coordination training, before each chemotherapy cycle-maximum one week- given the patient is in good state.
Sixty children with posterior fossa tumors of both sexes will participate in this study. They will be selected from CCHE. They will be randomly assigned into 3 groups of equal number.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
| Arm | Type | Receives |
|---|---|---|
| Control Group/Pilates Core Stability Exercises program Group | Active comparator | Behavioral: Pilates Core Stability Exercises programTwenty patients will receive Pilates core stability exercises program ONLY. Total Period: 12 Weeks Stages: Three stages: * Stage I: Warm-up: consists of four Pilates motions: 1. Breathing: 2. Rolling back: 3. Coccyx-curl: 4. Hundred breathing: * Stage II: Work-out: consists of twelve Pilates motions: 1. Single leg stretch: 2. Straight leg raise: 3. Basic bridge: 4. Bridging variation: 5. Quadruped: 6. Clap with seal motion 7. Mermaid twist: 8. Swimming: 9. Double leg stretch: 10. Shoulder bridge: 11. Swan dive: 12. Leg full front: * Stage III: Cool-down: consists of three Pilates motions: 1. Rest position: 2. Cat with arm/leg extension: 3. Breathing: |
| Balance Group | Experimental | Behavioral: Pilates Core Stability Exercises program, Behavioral: Balance ProgramTwenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Balance Program |
| Coordination Group | Experimental | Behavioral: Pilates Core Stability Exercises program, Behavioral: CoordinationTwenty patients will receive the same selected Pilates core stability exercises program given to control group in addition to Coordination Exercises. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children with posterior fossa tumors during follow up.
- Children between 5-12 years old.
- Time elapsed since the start of treatment more than 4 months in order to be in maintenance phase.
- They can understand verbal command.
- Children with no visual, auditory or perceptual disorders.
Key exclusion criteria (5 listed)
- Children who have one or more of the following criteria will be excluded from the study:
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 |
|---|---|---|
| Pilates Core Stability Exercises programTwenty patients will receive Pilates core stability exercises program ONLY. Total Period: 12 Weeks Stages: Three stages: * Stage I: Warm-up: consists of four Pilates motions: 1. Breathing: 2. Rolling back: 3. Coccyx-curl: 4. Hundred breathing: * Stage II: Work-out: consists of twelve Pilates motions: 1. Single leg stretch: 2. Straight leg raise: 3. Basic bridge: 4. Bridging variation: 5. Quadruped: 6. Clap with seal motion 7. Mermaid twist: 8. Swimming: 9. Double leg stretch: 10. Shoulder bridge: 11. Swan dive: 12. Leg full front: * Stage III: Cool-down: consists of three Pilates motions: 1. Rest position: 2. Cat with arm/leg extension: 3. Breathing: | Behavioural | Balance Group, Control Group/Pilates Core Stability Exercises program Group, Coordination Group |
| Balance ProgramAlso: HUMAC programTotal Period: 12 Weeks. The designed HUMAC program will work on the modified clinical test of sensory integration of balance (mCTSIB) with eyes open and with eyes closed, the center of pressure (COP) and the limit of stability test (LOS). | Behavioural | Balance Group |
| CoordinationTotal Period: 12 Weeks. Coordination will be assessed using BOT2, Bilateral coordination (Sub test No.4) composed of 7 items and Upper-Limb coordination (Sub test No.7) composed of 7 items too. The raw scores are recorded first then it is converted into point scores, then subtest total point score is obtained by adding point scores. | Behavioural | Coordination Group |
Primary outcome
Change Balance
Time frame: at week 12
For assessment of the three groups, HUMAC balance and tilt system will be used to assess both Static and dynamic balance.
1 secondary outcome
Change Coordination
Time frame: at week 12
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 4 Aug 2021.
- Derived from this study: PubMed 36525069Usama M, Abdelaziem F, Rashed WM, Maher E, El Beltagy M, Zekri W. Impact of physical activity on postural stability and coordination in children with posterior fossa tumor: randomized control phase III trial. J Cancer Res Clin Oncol. 2023 Aug;149(9):5637-5644. doi: 10.1007/s00432-022-04490-4. Epub 2022 Dec 16.
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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.
Mahmoud Usama Mahmoud Ahmed, MSc 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 Pilates Core Stability Exercises program, Balance Program and Coordination in people with Posterior Fossa Tumor and Medulloblastoma, Childhood, 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 6 inclusion and 5 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 4 Aug 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?
Change Balance (time frame: at week 12). 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 NCT04528316, 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 4 Aug 2021.