Cerebral Palsy Spastic DiplegiaNCT06233136
Effect of Leg Pedalling Exercise From Inclined Position
A study testing Leg pedalling exercise and The designed physical therapy program in people with Cerebral Palsy Spastic Diplegia, run by Cairo University at 1 site in Egypt.
Trial summary
Statement of the problem:- Does the lower limb pedalling exercise from inclined position improve functional ability and trunk control in children with diplegic cerebral palsy? Null Hypothesis:- There will be no effect of lower limb pedalling exercise from inclined position on functional ability and trunk control in… Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- Leg pedalling exercise and The designed physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Mar 2023to 15 Aug 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- .Age ranges from 6-9 years. .Grade 1, 1+ of the Modified Ashworth Scale.
- .Level II, III according to Gross MotorFunctional Classification System (GMFCS).
- .Able to pedal independently on a static bicycle.
- .Ability to follow command.
Who cannot join
- .Significant visual or auditory impairments.
- .Structural or fixed deformities of lower extremities.
- .Perception disorders.
- .Botox injection in the lower extremity in the past 6 months.
- .Lower extremity surgery within the past 6 months.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy cairo University
Dokki, Giza Governorate, 12613
About this study
Official title: Effect of Leg Pedalling Exercise From Inclined Position on Functional Ability and Trunk Control in Children With Diplegic Cerebral Palsy
Statement of the problem:- Does the lower limb pedalling exercise from inclined position improve functional ability and trunk control in children with diplegic cerebral palsy? Null Hypothesis:- There will be no effect of lower limb pedalling exercise from inclined position on functional ability and trunk control in children with diplegic cerebral palsy
Read the detailed description
Subjects A convenient sample of children diagnosed as spastic diplegic cerebral palsy (CP) from both sexes will be recruited based on a pilot study according to the inclusion and exclusion criteria. They will be selected from the out-patient private clinics in Giza and Tenth of Ramadan City.
Study design:
Randomized controlled clinical trial. Children will receive intervention type randomly, 15 child received the designed physical therapy program and the pedaling exercise from inclined position and the other 15 child receieved the designed physical therapy program only. Children will be assessed by measuring functional ability with Gross Motor Functional measures and trunk control with trunk control measurement scale
- Conditions
- Cerebral Palsy Spastic Diplegia
- Being tested
- Leg pedalling exercise, The designed physical therapy program
- Keywords
- Leg Pedalling
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg pedalling exerciseDevice
Also called Leg ergometer
Each child in the experimental group will be positioned in inclined position and will cycle through the range of motion under the supervision of the researcher
The designed physical therapy programOther
Also called Traditional physical therapy program
It applied for all participated children in both groups. It includes;
- Flexibility exercises
- Static and dynamic balance
- Functional training exercises
| Study group | Role | What they receive |
|---|---|---|
| Leg Pedalling exercise and designed physical therapy program | Experimental | Each child in the experimental group will be positioned in semi-reclined position with 45 degree trunk flexion during the application of cycling Sessions will be 30 minutes per session, three times per week, for two successive months The designed physical therapy program It will be applied for all participated children in both groups. It includes;
1. Flexibility exercises
2. Static and dynamic balance exercises
3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month Receives: Device: Leg pedalling exercise; Other: The designed physical therapy program |
| Designed physical therapy program | Active comparator | The designed physical therapy program It will be applied for all participated children in both groups. It includes;
1. Flexibility exercises
2. Static and dynamic balance exercises
3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month Receives: Other: The designed physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The gross motor function scale
Assessment of change of functional ability carried out by using gross motor function measures
Measured: 2 months for each participant
Assessment of trunk control
Assessment of change of trunk control carried out by using trunk control measurement scale
Measured: 2 months for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start13 Mar 2023
- Primary completion15 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic DiplegiaStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Bahgat mahmoud Hasan, Cairo University
- Investigators
- NANEES E Mohamed, Phd, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233136
- Sponsor's protocol ID
- P.T.REC/012/004085
- Status last verified
- Jan 2024
- First submitted
- 24 Jul 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Leg Pedalling Exercise From Inclined Position on Functional Ability and Trunk Control in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06233136
- Acronym / sponsor ID
- P.T.REC/012/004085
- Conditions
- Cerebral Palsy Spastic Diplegia
- Keywords
- Leg Pedalling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 31 Jan 2024 (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.
Statement of the problem:- Does the lower limb pedalling exercise from inclined position improve functional ability and trunk control in children with diplegic cerebral palsy? Null Hypothesis:- There will be no effect of lower limb pedalling exercise from inclined position on functional ability and trunk control in children with diplegic cerebral palsy
Detailed description
Subjects A convenient sample of children diagnosed as spastic diplegic cerebral palsy (CP) from both sexes will be recruited based on a pilot study according to the inclusion and exclusion criteria. They will be selected from the out-patient private clinics in Giza and Tenth of Ramadan City.
Study design:
Randomized controlled clinical trial. Children will receive intervention type randomly, 15 child received the designed physical therapy program and the pedaling exercise from inclined position and the other 15 child receieved the designed physical therapy program only. Children will be assessed by measuring functional ability with Gross Motor Functional measures and trunk control with trunk control measurement scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leg Pedalling exercise and designed physical therapy program | Experimental | Device: Leg pedalling exercise, Other: The designed physical therapy programEach child in the experimental group will be positioned in semi-reclined position with 45 degree trunk flexion during the application of cycling Sessions will be 30 minutes per session, three times per week, for two successive months The designed physical therapy program It will be applied for all participated children in both groups. It includes; 1. Flexibility exercises 2. Static and dynamic balance exercises 3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month |
| Designed physical therapy program | Active comparator | Other: The designed physical therapy programThe designed physical therapy program It will be applied for all participated children in both groups. It includes; 1. Flexibility exercises 2. Static and dynamic balance exercises 3. Functional training Sessions will be 45 minutes per session, three times per week, for two successive month |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- .Age ranges from 6-9 years. .Grade 1, 1+ of the Modified Ashworth Scale.
- .Level II, III according to Gross MotorFunctional Classification System (GMFCS).
- .Able to pedal independently on a static bicycle.
- .Ability to follow command.
Key exclusion criteria (5 listed)
- .Significant visual or auditory impairments.
- .Structural or fixed deformities of lower extremities.
- .Perception disorders.
- .Botox injection in the lower extremity in the past 6 months.
- .Lower extremity surgery within the past 6 months.
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 |
|---|---|---|
| Leg pedalling exerciseAlso: Leg ergometerEach child in the experimental group will be positioned in inclined position and will cycle through the range of motion under the supervision of the researcher | Device | Leg Pedalling exercise and designed physical therapy program |
| The designed physical therapy programAlso: Traditional physical therapy programIt applied for all participated children in both groups. It includes; 1. Flexibility exercises 2. Static and dynamic balance 3. Functional training exercises | Other | Designed physical therapy program, Leg Pedalling exercise and designed physical therapy program |
Primary outcome
The gross motor function scale
Time frame: 2 months for each participant
Assessment of change of functional ability carried out by using gross motor function measures
Assessment of trunk control
Time frame: 2 months for each participant
Assessment of change of trunk control carried out by using trunk control measurement scale
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 31 Jan 2024.
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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.
NANEES E Mohamed, Phd study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leg pedalling exercise and The designed physical therapy program in people with Cerebral Palsy Spastic Diplegia, 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 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 31 Jan 2024. 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?
The gross motor function scale (time frame: 2 months for each participant). The study lists 2 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 31 Jan 2024.