Cerebral PalsyNCT04272398
Effects of Using Dynamic Elastomeric Fabric Orthoses
A study testing dynamic elastomeric fabric orthoses in people with Cerebral Palsy and Movement Disorders, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: The aim of this study was to investigate the effects of dynamic elastomeric fabric orthoses (DEFOs) used for lower trunk and pelvis on balance, gait parameters, and pelvis symmetry in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Cerebral Palsy, Movement Disorders, Neurologic Disorder
- What is being tested?
- dynamic elastomeric fabric orthoses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both the child and the family need to volunteer to participate in the study, diagnosis of spastic type CP with bilateral or unilateral involvement,
- being at level 1 or 2 based on the Gross Motor Function Classification System (GMFCS) and
- being in an age range of 4-10 years.
Who cannot join
- who had received botulinum toxin/surgery at the lower extremity and/or pelvis in the previous six months and those who were going to receive this treatment during the study were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of the Effects of Dynamic Elastomeric Fabric Orthoses Used for Lower Body and Pelvis in Children With Cerebral Palsy on Balance, Gait Parameters, and Pelvic Symmetry
Purpose: The aim of this study was to investigate the effects of dynamic elastomeric fabric orthoses (DEFOs) used for lower trunk and pelvis on balance, gait parameters, and pelvis symmetry in children with cerebral palsy.
Materials and Methods: Twenty-two children (7 girls, 15 boys) in an age range of 4-10 years, with spastic type cerebral palsy, and at gross motor function classification system levels 1 or 2 were included in the study. Children who met the inclusion criteria were randomly divided into two groups. Ten children were included in the control group (Group I) and 12 children were included in the orthosis group (Group II). Both groups received a physiotherapy and rehabilitation program twice a week for 8 weeks in accordance with neurodevelopmental treatment approaches. Children in Group II were treated with DEFOs in lower body and pelvis in addition to physiotherapy and rehabilitation sessions. The use frequency of the orthosis was extended over the course of the week during which they were active for 8 hours a day. After the demographic data of the children were recorded, the Pediatric Balance Scale and the Timed Up and Go Test were used for balance assessment. Gait parameters and kinematic values of the pelvis were evaluated using the BTS G-Walk®, a wireless mini digital gait analysis system.
Read the detailed description
All groups received a physiotherapy and rehabilitation program two sessions per week, for 45 minutes, for a total of 8 weeks. The program was administered by a physiotherapist and prepared in accordance with neurodevelopmental treatment approaches. At other times, families continued to practice the exercises. An appropriate treatment plan was developed according to the needs and characteristics of each participant. Ensuring proper posture in different positions, increasing body awareness, and facilitating trunk extension were included in the treatment plan. For the development of postural control in standing and walking without support, weight transfer studies on the affected and less affected sides with trunk elongation were emphasized. Step up/down exercises were performed on both the affected and less affected sides. Supported by appropriate hand gripping, two-feet forward jumping, one-foot forward jumping, and weight transfer on one leg exercises were performed. Providing sensory inputs during all exercises was given importance. Exercises were conducted particularly to strengthen the antagonists of the spastic muscles. Stretching exercises were carried out in functional positions with active participation of the child as much as possible. The home program was shown to the family in detail in parallel with the physiotherapist's practices and the program was revised regularly. While Group I continued physiotherapy and rehabilitation sessions, the children in Group II wore DEFOs with a focus on the lower body and pelvis in addition to the physiotherapy and rehabilitation sessions. The frequency of the use of the orthosis was planned to extend through the week and they had the orthosis during their active hours during the day about 8 hours a day. In order to reduce the loosening of the fabric caused by extensive use, it was recommended that the orthosis be removed and reworn at two-hour intervals. The children wore the DEFOs for 8 weeks with this frequency. The frequency of use was monitored using a chart. Children were evaluated at the beginning of the study and after 8 weeks. An assessment environment was created for each child when they felt energetic and well. In order to prevent fatigue, short breaks were given. All evaluations were performed in the same environment in standardized conditions and without orthosis. Gait analysis was performed with bare feet.
- Conditions
- Cerebral Palsy, Movement Disorders, Neurologic Disorder
- Being tested
- dynamic elastomeric fabric orthoses
- Keywords
- cerebral palsy, dynamic orthoses, gait analysis, movement, neoprene, rehabilitation
- Medical subject headings
- Cerebral Palsy, Movement Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic elastomeric fabric orthosesOther
Wore dynamic elastomeric fabric orthoses with a focus on the lower body and pelvis in addition to the physiotherapy and rehabilitation sessions. The frequency of the use of the orthosis was planned to extend through the week and they had the orthosis during their active hours during the day about 8 hours a day.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Used dynamic elastomeric fabric orthoses with physiotherapy and rehabilitation program Receives: Other: dynamic elastomeric fabric orthoses |
| Control | Experimental | Only physiotherapy and rehabilitation program Receives: Other: dynamic elastomeric fabric orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Second with Time and go test
Measured: 8 weeks
Walking speed
(meter/second)
Measured: 8 weeks
Stance phase
its percentage within gait cycle
Measured: 8 weeks
Swing phase
its percentage within gait cycle
Measured: 8 weeks
Symmetry Index of Pelvic Movements
percentage
Measured: 8 weeks
Secondary outcomes (2)
Step length
its percentage within two-step length
Measured: 8 weeks
Single support phase
its percentage within two-step length
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Mar 2018
- Primary completion1 Feb 2019
- Study completion1 May 2019
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabiha BEZGİN, Kırıkkale University
- Investigators
- Sabiha Bezgin, PhD, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272398
- Sponsor's protocol ID
- Kirikkale U
- Status last verified
- Feb 2020
- First submitted
- 11 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bezgin S, Novak I, Cobanoglu G, Elbasan B. Effects of dynamic elastomeric fabric orthoses in children with cerebral palsy: A single-blind randomized controlled trial. Prosthet Orthot Int. 2025 Apr 1;49(2):220-227. doi: 10.1097/PXR.0000000000000425. Epub 2024 Dec 24.
PubMed 39721059
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effects of Dynamic Elastomeric Fabric Orthoses Used for Lower Body and Pelvis in Children With Cerebral Palsy on Balance, Gait Parameters, and Pelvic Symmetry
- ClinicalTrials.gov ID
- NCT04272398
- Acronym / sponsor ID
- Kirikkale U
- Conditions
- Cerebral Palsy, Movement Disorders, Neurologic Disorder
- Keywords
- cerebral palsy, dynamic orthoses, gait analysis, movement, neoprene, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 17 Feb 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.
Purpose: The aim of this study was to investigate the effects of dynamic elastomeric fabric orthoses (DEFOs) used for lower trunk and pelvis on balance, gait parameters, and pelvis symmetry in children with cerebral palsy.
Materials and Methods: Twenty-two children (7 girls, 15 boys) in an age range of 4-10 years, with spastic type cerebral palsy, and at gross motor function classification system levels 1 or 2 were included in the study. Children who met the inclusion criteria were randomly divided into two groups. Ten children were included in the control group (Group I) and 12 children were included in the orthosis group (Group II). Both groups received a physiotherapy and rehabilitation program twice a week for 8 weeks in accordance with neurodevelopmental treatment approaches. Children in Group II were treated with DEFOs in lower body and pelvis in addition to physiotherapy and rehabilitation sessions. The use frequency of the orthosis was extended over the course of the week during which they were active for 8 hours a day. After the demographic data of the children were recorded, the Pediatric Balance Scale and the Timed Up and Go Test were used for balance assessment. Gait parameters and kinematic values of the pelvis were evaluated using the BTS G-Walk®, a wireless mini digital gait analysis system.
Detailed description
All groups received a physiotherapy and rehabilitation program two sessions per week, for 45 minutes, for a total of 8 weeks. The program was administered by a physiotherapist and prepared in accordance with neurodevelopmental treatment approaches. At other times, families continued to practice the exercises. An appropriate treatment plan was developed according to the needs and characteristics of each participant. Ensuring proper posture in different positions, increasing body awareness, and facilitating trunk extension were included in the treatment plan. For the development of postural control in standing and walking without support, weight transfer studies on the affected and less affected sides with trunk elongation were emphasized. Step up/down exercises were performed on both the affected and less affected sides. Supported by appropriate hand gripping, two-feet forward jumping, one-foot forward jumping, and weight transfer on one leg exercises were performed. Providing sensory inputs during all exercises was given importance. Exercises were conducted particularly to strengthen the antagonists of the spastic muscles. Stretching exercises were carried out in functional positions with active participation of the child as much as possible. The home program was shown to the family in detail in parallel with the physiotherapist's practices and the program was revised regularly. While Group I continued physiotherapy and rehabilitation sessions, the children in Group II wore DEFOs with a focus on the lower body and pelvis in addition to the physiotherapy and rehabilitation sessions. The frequency of the use of the orthosis was planned to extend through the week and they had the orthosis during their active hours during the day about 8 hours a day. In order to reduce the loosening of the fabric caused by extensive use, it was recommended that the orthosis be removed and reworn at two-hour intervals. The children wore the DEFOs for 8 weeks with this frequency. The frequency of use was monitored using a chart. Children were evaluated at the beginning of the study and after 8 weeks. An assessment environment was created for each child when they felt energetic and well. In order to prevent fatigue, short breaks were given. All evaluations were performed in the same environment in standardized conditions and without orthosis. Gait analysis was performed with bare feet.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Other: dynamic elastomeric fabric orthosesUsed dynamic elastomeric fabric orthoses with physiotherapy and rehabilitation program |
| Control | Experimental | Other: dynamic elastomeric fabric orthosesOnly physiotherapy and rehabilitation program |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Both the child and the family need to volunteer to participate in the study, diagnosis of spastic type CP with bilateral or unilateral involvement,
- being at level 1 or 2 based on the Gross Motor Function Classification System (GMFCS) and
- being in an age range of 4-10 years.
Key exclusion criteria (1 listed)
- who had received botulinum toxin/surgery at the lower extremity and/or pelvis in the previous six months and those who were going to receive this treatment during the study were 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 |
|---|---|---|
| dynamic elastomeric fabric orthosesWore dynamic elastomeric fabric orthoses with a focus on the lower body and pelvis in addition to the physiotherapy and rehabilitation sessions. The frequency of the use of the orthosis was planned to extend through the week and they had the orthosis during their active hours during the day about 8 hours a day. | Other | Control, Treatment |
Primary outcome
Balance
Time frame: 8 weeks
Second with Time and go test
Walking speed
Time frame: 8 weeks
(meter/second)
Stance phase
Time frame: 8 weeks
its percentage within gait cycle
Swing phase
Time frame: 8 weeks
its percentage within gait cycle
Symmetry Index of Pelvic Movements
Time frame: 8 weeks
percentage
2 secondary outcomes
Step length
Time frame: 8 weeks
Single support phase
Time frame: 8 weeks
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 17 Feb 2020.
- Derived from this study: PubMed 39721059Bezgin S, Novak I, Cobanoglu G, Elbasan B. Effects of dynamic elastomeric fabric orthoses in children with cerebral palsy: A single-blind randomized controlled trial. Prosthet Orthot Int. 2025 Apr 1;49(2):220-227. doi: 10.1097/PXR.0000000000000425. Epub 2024 Dec 24.
- 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.
Sabiha Bezgin, PhD principal investigator
Kırıkkale 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 dynamic elastomeric fabric orthoses in people with Cerebral Palsy and Movement Disorders, run by Kırıkkale University 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 3 inclusion and 1 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 17 Feb 2020. 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?
Balance (time frame: 8 weeks). The study lists 5 primary outcomes in all. 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 NCT04272398, 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 17 Feb 2020.