Spastic Cerebral PalsyNCT03901703
The Effects of Functional Strengthening in Spastic Cerebral Palsy
A study testing Physiotherapy and Rehabilitation in people with Spastic Cerebral Palsy, run by Melek Volkan Yazici at 1 site in Turkey (Türkiye).
Trial summary
Functional strengthening exercises have been proven to be effective in patients with spastic cerebral palsy. However, which exercise is the most effective is unknown. The aim of this study is to examine the effectiveness of three different progressive functional exercise programs in children with unilateral and… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Physiotherapy and Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2019to 30 May 2019
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Accepting to participate in the study,
- Being between 5-15 years old,
- Having a diagnosis of Spastic Cerebral Palsy,
- Being level I-II according to GMFCS,
Who cannot join
- Having limited cooperation which prevents participation in the study,
- Refusing to participate in the study,
- Having an orthopedic disorder or systemic illness which prevents movement in the lower extremities,
- Having a Botulinum toxin application in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Progressive Functional Ankle Strengthening in Children With Unilateral and Bilateral Spastic Cerebral Palsy
Functional strengthening exercises have been proven to be effective in patients with spastic cerebral palsy. However, which exercise is the most effective is unknown. The aim of this study is to examine the effectiveness of three different progressive functional exercise programs in children with unilateral and bilateral spastic cerebral palsy.
Read the detailed description
Children with Cerebral Palsy have weakness in thier muscles due to cortical lesions leading to deficiencies in motor control, balance and functional abilities. All children with Cerebral Palsy have shown to present with foot and ankle disorders; the ankle dorsi and plantar flexor muscles are both problematic; the plantarflexors are usually spastic and the dorsiflexors are usually not active enough and usually these muscle problems lead to problems in the childrens' gait abilities. When rehabilitation programs are examined, the results of exercises addressing these problems do not have precise answers. Functional strengthening exercises have been proven to be effective in patients with spastic cerebral palsy. However, which exercise is the most effective is unknown. Which muscle goup has the most effect on gait, balance and functional activities is still unclear. Therefore, the investigator's aim in planning this study is to examine the effectiveness of three progressive functional exercise programs in children with unilateral and bilateral spastic cerebral palsy.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Physiotherapy and Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy and RehabilitationOther
The children in each group will receive 6 weeks of functional strengthening exercises targeting each muscle group according to the arm they are included in.
| Study group | Role | What they receive |
|---|---|---|
| Dorsiflexor Muscle Strengthening Group | Active comparator | The children in this group will receive functional exercises aiming to strengthen their dorsiflexor muscles alongside standard functional progressive strengthening exercises. Receives: Other: Physiotherapy and Rehabilitation |
| Plantarflexor Muscle Strengthening Group | Active comparator | The children in this group will receive functional exercises aiming to strengthen their plantarflexor muscles alongside standard functional progressive strengthening exercises. Receives: Other: Physiotherapy and Rehabilitation |
| Dorsiflexor and Plantarflexor Muscle strengthening Group | Active comparator | The children in this group will receive functional exercises aiming to strengthen both their dorsiflexor and plantarflexor muscles alongside standard functional progressive strengthening exercises. Receives: Other: Physiotherapy and Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: Change of The Pediatric balance scale at 6 weeks.
Surface Electromyography (sEMG)
Surface electromyography is a non-invasive procedure involving the detection, recording and interpretation of the electric activity of groups of muscles during activity. The procedure is performed using electrodes placed on the skin surface over the muscles to be tested. sEMG is also used to assess the effects of rehabilitation programs and evaluate muscular function in children with cerebral palsy. Due to its non-invasive properties it is safely and widely used in the pediatric population.
Measured: Change of sEMG data at 6 weeks.
The Six minute walk test
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. The test has been shown to be valid and reliable in children with Cerebral Palsy.
Measured: Change of 6 MWT at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start12 Jan 2019
- Primary completion15 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melek Volkan Yazici
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melek Volkan Yazici, Gazi University
- Investigators
- Bulent Elbasan, Assoc. Prof., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901703
- Sponsor's protocol ID
- 465426
- Status last verified
- Jul 2019
- First submitted
- 1 Apr 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The exercise protocols and results will be shared with other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Progressive Functional Ankle Strengthening in Children With Unilateral and Bilateral Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03901703
- Acronym / sponsor ID
- 465426
- Conditions
- Spastic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Melek Volkan YaziciUniversity, hospital or other
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 3 Apr 2019 (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.
Functional strengthening exercises have been proven to be effective in patients with spastic cerebral palsy. However, which exercise is the most effective is unknown. The aim of this study is to examine the effectiveness of three different progressive functional exercise programs in children with unilateral and bilateral spastic cerebral palsy.
Detailed description
Children with Cerebral Palsy have weakness in thier muscles due to cortical lesions leading to deficiencies in motor control, balance and functional abilities. All children with Cerebral Palsy have shown to present with foot and ankle disorders; the ankle dorsi and plantar flexor muscles are both problematic; the plantarflexors are usually spastic and the dorsiflexors are usually not active enough and usually these muscle problems lead to problems in the childrens' gait abilities. When rehabilitation programs are examined, the results of exercises addressing these problems do not have precise answers. Functional strengthening exercises have been proven to be effective in patients with spastic cerebral palsy. However, which exercise is the most effective is unknown. Which muscle goup has the most effect on gait, balance and functional activities is still unclear. Therefore, the investigator's aim in planning this study is to examine the effectiveness of three progressive functional exercise programs in children with unilateral and bilateral spastic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dorsiflexor Muscle Strengthening Group | Active comparator | Other: Physiotherapy and RehabilitationThe children in this group will receive functional exercises aiming to strengthen their dorsiflexor muscles alongside standard functional progressive strengthening exercises. |
| Plantarflexor Muscle Strengthening Group | Active comparator | Other: Physiotherapy and RehabilitationThe children in this group will receive functional exercises aiming to strengthen their plantarflexor muscles alongside standard functional progressive strengthening exercises. |
| Dorsiflexor and Plantarflexor Muscle strengthening Group | Active comparator | Other: Physiotherapy and RehabilitationThe children in this group will receive functional exercises aiming to strengthen both their dorsiflexor and plantarflexor muscles alongside standard functional progressive strengthening exercises. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Accepting to participate in the study,
- Being between 5-15 years old,
- Having a diagnosis of Spastic Cerebral Palsy,
- Being level I-II according to GMFCS,
Key exclusion criteria (4 listed)
- Having limited cooperation which prevents participation in the study,
- Refusing to participate in the study,
- Having an orthopedic disorder or systemic illness which prevents movement in the lower extremities,
- Having a Botulinum toxin application in the last 3 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 |
|---|---|---|
| Physiotherapy and RehabilitationThe children in each group will receive 6 weeks of functional strengthening exercises targeting each muscle group according to the arm they are included in. | Other | Dorsiflexor Muscle Strengthening Group, Dorsiflexor and Plantarflexor Muscle strengthening Group, Plantarflexor Muscle Strengthening Group |
Primary outcome
Pediatric Balance scale
Time frame: Change of The Pediatric balance scale at 6 weeks.
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Surface Electromyography (sEMG)
Time frame: Change of sEMG data at 6 weeks.
Surface electromyography is a non-invasive procedure involving the detection, recording and interpretation of the electric activity of groups of muscles during activity. The procedure is performed using electrodes placed on the skin surface over the muscles to be tested. sEMG is also used to assess the effects of rehabilitation programs and evaluate muscular function in children with cerebral palsy. Due to its non-invasive properties it is safely and widely used in the pediatric population.
The Six minute walk test
Time frame: Change of 6 MWT at 6 weeks.
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. The test has been shown to be valid and reliable in children with Cerebral Palsy.
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 30 Jul 2019.
- Individual participant dataSharing planned: No. The exercise protocols and results will be shared with other investigators.
Related trials for Spastic Cerebral Palsy
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
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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.
Bulent Elbasan, Assoc. Prof. study director
Gazi 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 Physiotherapy and Rehabilitation in people with Spastic Cerebral Palsy, run by Melek Volkan Yazici at 1 site in Turkey (Türkiye).
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 4 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 30 Jul 2019. 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 Turkey (Türkiye). 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?
Pediatric Balance scale (time frame: Change of The Pediatric balance scale at 6 weeks.). 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 30 Jul 2019.