AtaxiaPhase 2NCT05125666
Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection
A Phase 2 study testing Dual Task Training (Motor + Cognitive) and Traditional Regular Exercise in people with Ataxia and Medulloblastoma, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of using a selected dual-task- training program to improve postural stability in children with ataxia after medulloblastoma resection. Thirty patients will participate in this study. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Ataxia, Medulloblastoma
- What is being tested?
- Dual Task Training (Motor + Cognitive) and Traditional Regular Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Mar 2022
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- All children with the following criteria will be in rolled in the study
- 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 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.
Egypt1 site, 1 recruiting
- Recruiting
57357 Children Cancer Hospital
Cairo, El Sayeda Zainab
Moatsem El Ayadi, MD
About this study
Official title: Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection: (A Randomized Controlled Trial)
The aim of this study is to evaluate the effect of using a selected dual-task- training program to improve postural stability in children with ataxia after medulloblastoma resection. Thirty patients will participate in this study. Patients will be classified randomly into two equal groups: study and control groups -Both groups will receive conventional physical therapy treatment including mobility exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning. In addition, the study group will receive a selected dual-task training program including balance and cognitive activities. The treatment program will be conducted three days per week for eight successive weeks. The patients will be assessed with the Scale of Assessment and Rating of Ataxia, Humac Balance System, the Pediatric Balance Scale and Functional Independent Measurement. The measures will be recorded two times: before the application of the treatment program (pre) and after the end of the treatment program (post).
- Conditions
- Ataxia, Medulloblastoma
- Being tested
- Dual Task Training (Motor + Cognitive), Traditional Regular Exercise
- Medical subject headings
- Ataxia, Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Task Training (Motor + Cognitive)Other
Each child in this group will perform one-hour session consist of two tasks (cognitive and balance task) in addition to the traditional physical therapy program three times weekly for 8 successive weeks.
Traditional Regular ExerciseOther
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 |
|---|---|---|
| Dual Task Training | Experimental | Not described Receives: Other: Dual Task Training (Motor + Cognitive) |
| Ordinary Physical Therapy for Ataxia | Active comparator | Not described Receives: Other: Traditional Regular Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Static balance of patients with ataxia after resection measured by center of pressure using force plate mode in the humac balance system.
Measured: 2 months
Improvement in dynamic balance of patients with ataxia after resection measured by using tilt mode in the humac balance system.
Measured: 2 months
Improvement in Activities of Daily Living (ADL) measured by functional independence measurement.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Oct 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mostafa Sedeek Selim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125666
- Sponsor's protocol ID
- DTT-Ataxia-1
- Status last verified
- Nov 2021
- First submitted
- 2 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. 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: (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT05125666
- Acronym / sponsor ID
- DTT-Ataxia-1
- Conditions
- Ataxia, Medulloblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 18 Nov 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.
The aim of this study is to evaluate the effect of using a selected dual-task- training program to improve postural stability in children with ataxia after medulloblastoma resection. Thirty patients will participate in this study. Patients will be classified randomly into two equal groups: study and control groups -Both groups will receive conventional physical therapy treatment including mobility exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning. In addition, the study group will receive a selected dual-task training program including balance and cognitive activities. The treatment program will be conducted three days per week for eight successive weeks. The patients will be assessed with the Scale of Assessment and Rating of Ataxia, Humac Balance System, the Pediatric Balance Scale and Functional Independent Measurement. The measures will be recorded two times: before the application of the treatment program (pre) and after the end of the treatment program (post).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Task Training | Experimental | Other: Dual Task Training (Motor + Cognitive) |
| Ordinary Physical Therapy for Ataxia | Active comparator | Other: Traditional Regular Exercise |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- All children with the following criteria will be in rolled in the study
- 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.
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 (Motor + Cognitive)Each child in this group will perform one-hour session consist of two tasks (cognitive and balance task) in addition to the traditional physical therapy program three times weekly for 8 successive weeks. | Other | Dual Task Training |
| Traditional Regular ExerciseEach 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. | Other | Ordinary Physical Therapy for Ataxia |
Primary outcome
Improvement in Static balance of patients with ataxia after resection measured by center of pressure using force plate mode in the humac balance system.
Time frame: 2 months
Improvement in dynamic balance of patients with ataxia after resection measured by using tilt mode in the humac balance system.
Time frame: 2 months
Improvement in Activities of Daily Living (ADL) measured by functional independence measurement.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dual Task Training (Motor + Cognitive) and Traditional Regular Exercise in people with Ataxia and Medulloblastoma, 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 8 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: status not confirmed, as of the sponsor's last update on 18 Nov 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma M Sedeek, BSc (01201980290, ptfatmaselim@gmai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Static balance of patients with ataxia after resection measured by center of pressure using force plate mode in the humac balance system. (time frame: 2 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?
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 18 Nov 2021.