Gait, SpasticNCT05583929
Walking Ability and Limit of Stability in Children With Spastic Cerebral Palsy
An observational study of Gait, Spastic, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
Trunk control in children with spastic Cerebral Palsy (CP) is impaired. They have weaker trunk muscle strenght, and insufficient sitting/standing balance according to their developing peers. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait, Spastic
- What is being tested?
- GAITRite gaitway system, Bertec Balance System
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Nov 2022to 1 Jun 2024
- Phase
- Observational
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Spastic cerebral palsy and their developing peers
Who may be able to join
- spastic serebral palsy, between the ages 6-15 years, between the I-IV. levels of GMFCS, be able to understand command given by physical therapist
Who cannot join
- undergone botulinum toxin A to upper and/or lower extremities, undergone any surgery to their extremities, be at the V. levels of GMFCS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Altındağ, Ankara
Bayram Sırrı, MSc, 05362410774, bayramsirri@gmail.com
Semra Topuz, Prof.
About this study
Official title: an Investigation of the Relationship Between Walking Ability and Limit of Stability in Children With Spastic Cerebral Palsy
Trunk control in children with spastic Cerebral Palsy (CP) is impaired. They have weaker trunk muscle strenght, and insufficient sitting/standing balance according to their developing peers. Since their weak trunk muscles and insufficient balance responses, they are not able to walk as functional similar to their peers. Additionaly limit of stability is worsen in children with CP. Investigation of the relationship between walking ability and limit of stability when seated position is important to understand which child is acceptable for training of walk. However we did not found any study to explain it. Therefore the aim of this study is to investigate walking ability and limit of stability in children with spastic CP, and to compare their developing peers.
- Conditions
- Gait, Spastic
- Being tested
- GAITRite gaitway system, Bertec Balance System
- Keywords
- gait, walking ability, limit of stability, cerebral palsy
- Medical subject headings
- Gait Disorders, Neurologic, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAITRite gaitway system, Bertec Balance SystemOther
GAITRite gaitway system will use to assess gait parameters, Bertec Balance System will use to assess limit of stability
| Study group | Role | What they receive |
|---|---|---|
| Spastic Cerebral Palsy | Children with spastic cerebral palsy Receives: Other: GAITRite gaitway system, Bertec Balance System | |
| Healthy Developing Peers | Children with healthy developing peers Receives: Other: GAITRite gaitway system, Bertec Balance System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameters (stride length in cm, step width in cm, time in swing phase in second, time in stance phase in second)
Gait parameters will be assessed by GAITRite walking way system.
Measured: 20 minutes
Limit of stability when sitting and standing position in cm
Limit of stability will be evaluated by BERTEC balance system.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start29 Nov 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, SpasticStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bayram Sırrı, Muş Alparslan University
- Investigators
- Bayram Sırrı, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583929
- Sponsor's protocol ID
- GO-22/398
- Status last verified
- Nov 2022
- First submitted
- 7 Oct 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- an Investigation of the Relationship Between Walking Ability and Limit of Stability in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05583929
- Acronym / sponsor ID
- GO-22/398
- Conditions
- Gait, Spastic
- Keywords
- gait, walking ability, limit of stability, cerebral palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 18 Oct 2022 (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.
Trunk control in children with spastic Cerebral Palsy (CP) is impaired. They have weaker trunk muscle strenght, and insufficient sitting/standing balance according to their developing peers. Since their weak trunk muscles and insufficient balance responses, they are not able to walk as functional similar to their peers. Additionaly limit of stability is worsen in children with CP. Investigation of the relationship between walking ability and limit of stability when seated position is important to understand which child is acceptable for training of walk. However we did not found any study to explain it. Therefore the aim of this study is to investigate walking ability and limit of stability in children with spastic CP, and to compare their developing peers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spastic Cerebral Palsy | – | Other: GAITRite gaitway system, Bertec Balance SystemChildren with spastic cerebral palsy |
| Healthy Developing Peers | – | Other: GAITRite gaitway system, Bertec Balance SystemChildren with healthy developing peers |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Spastic cerebral palsy and their developing peers
Key inclusion criteria (1 listed)
- spastic serebral palsy, between the ages 6-15 years, between the I-IV. levels of GMFCS, be able to understand command given by physical therapist
Key exclusion criteria (1 listed)
- undergone botulinum toxin A to upper and/or lower extremities, undergone any surgery to their extremities, be at the V. levels of GMFCS
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 |
|---|---|---|
| GAITRite gaitway system, Bertec Balance SystemGAITRite gaitway system will use to assess gait parameters, Bertec Balance System will use to assess limit of stability | Other | Healthy Developing Peers, Spastic Cerebral Palsy |
Primary outcome
Gait parameters (stride length in cm, step width in cm, time in swing phase in second, time in stance phase in second)
Time frame: 20 minutes
Gait parameters will be assessed by GAITRite walking way system.
Limit of stability when sitting and standing position in cm
Time frame: 20 minutes
Limit of stability will be evaluated by BERTEC balance system.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Gait, Spastic
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Active, not recruiting
Flexibility, Resistance, Aerobic, Movement Execution Training in Adults With Hereditary Spastic Paraplegia
Hereditary Spastic Paraplegia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Not yet recruiting
Dual-Task Training in Children With Spastic Diplegic Cerebral Palsy
Spastic Diplegia Cerebral Palsy
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.
Bayram Sırrı, MSc principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait, Spastic, run by Muş Alparslan 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 1 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: status not confirmed, as of the sponsor's last update on 2 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bayram Sırrı, PT, MSc, (+905362410774, bayramsirri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait parameters (stride length in cm, step width in cm, time in swing phase in second, time in stance phase in second) (time frame: 20 minutes). 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 2 Dec 2022.