Cerebral PalsyNCT02105649
Calf Muscle Strength and Standing Efficiency in Children With Spastic Diplegia
A study testing Strengthening exercise + Electrical stimulation of calf muscle and selected physical therapy program in people with Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
It will be hypothesized that strengthening the calf muscles will improve standing efficiency in children with spastic diplegia. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Strengthening exercise + Electrical stimulation of calf muscle and selected physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Aug 2014
- 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 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age will be ranging between 2 and 4 years.
- They are classified at level III by GMFCS-ER, i.e. they can stand with minimal support.
- Full mobile lower limbs joints.
- Children with mild and moderate spasticity ( i.e. grade 1 and 2, according to Modified Ashworth Scale).
Who cannot join
- Children with severe spasticity ( i.e. grade 4, according to Modified Ashworth Scale).
- Fixed deformities.
- Uncontrolled seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CALF MUSCLE STRENGTH AND STANDING EFFICIENCY IN CHILDREN WITH SPASTIC DIPLEGIA: A RANDOMIZED CONTROLLED TRIAL
It will be hypothesized that strengthening the calf muscles will improve standing efficiency in children with spastic diplegia.
- Conditions
- Cerebral Palsy
- Being tested
- Strengthening exercise + Electrical stimulation of calf muscle, selected physical therapy program
- Keywords
- cerebral palsy, standing, strengthening
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening exercise + Electrical stimulation of calf muscleOther
selected physical therapy programOther
| Study group | Role | What they receive |
|---|---|---|
| calf muscle strengthenig group | Experimental | experimental group
will receive the same selected physical therapy program in addition to manual and mechanical strengthening exercises and electrical stimulation program for calf muscles of both lower limbs. Receives: Other: Strengthening exercise + Electrical stimulation of calf muscle; Other: selected physical therapy program |
| No calf muscle strengthening group | Other | control group
will receive only the selected physical therapy program Receives: Other: selected physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure
Measured: 2 months
Secondary outcomes (1)
Ultrasonography
To measure calf muscle thickness
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 posted7 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionAug 2014
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 Cerebral PalsyStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Elsayed Elnahhas, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105649
- Sponsor's protocol ID
- 12345
- Status last verified
- Feb 2015
- First submitted
- 3 Apr 2014
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wiley ME, Damiano DL. Lower-extremity strength profiles in spastic cerebral palsy. Dev Med Child Neurol. 1998 Feb;40(2):100-7. doi: 10.1111/j.1469-8749.1998.tb15369.x.
PubMed 9489498
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CALF MUSCLE STRENGTH AND STANDING EFFICIENCY IN CHILDREN WITH SPASTIC DIPLEGIA: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT02105649
- Acronym / sponsor ID
- 12345
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, standing, strengthening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Apr 2014 (estimated)
- 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.
It will be hypothesized that strengthening the calf muscles will improve standing efficiency in children with spastic diplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calf muscle strengthenig group | Experimental | Other: Strengthening exercise + Electrical stimulation of calf muscle, Other: selected physical therapy programexperimental group will receive the same selected physical therapy program in addition to manual and mechanical strengthening exercises and electrical stimulation program for calf muscles of both lower limbs. |
| No calf muscle strengthening group | Other | Other: selected physical therapy programcontrol group will receive only the selected physical therapy program |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children age will be ranging between 2 and 4 years.
- They are classified at level III by GMFCS-ER, i.e. they can stand with minimal support.
- Full mobile lower limbs joints.
- Children with mild and moderate spasticity ( i.e. grade 1 and 2, according to Modified Ashworth Scale).
Key exclusion criteria (3 listed)
- Children with severe spasticity ( i.e. grade 4, according to Modified Ashworth Scale).
- Fixed deformities.
- Uncontrolled seizures.
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 |
|---|---|---|
| Strengthening exercise + Electrical stimulation of calf muscle | Other | calf muscle strengthenig group |
| selected physical therapy program | Other | No calf muscle strengthening group, calf muscle strengthenig group |
Primary outcome
Gross Motor Function Measure
Time frame: 2 months
1 secondary outcome
Ultrasonography
Time frame: 2 months
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 Feb 2015.
- Background: PubMed 9489498Wiley ME, Damiano DL. Lower-extremity strength profiles in spastic cerebral palsy. Dev Med Child Neurol. 1998 Feb;40(2):100-7. doi: 10.1111/j.1469-8749.1998.tb15369.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening exercise + Electrical stimulation of calf muscle and selected physical therapy program in people with Cerebral Palsy, 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 3 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 Feb 2015. 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?
Gross Motor Function Measure (time frame: 2 months). 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 NCT02105649, 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 Feb 2015.