Cerebral PalsyFMSNCT05145231
valıdıty and relıabılıty of the turkısh versıon of the functıonal mobılıty Scale ın ındıvıduals wıth Cerebral Palsy
An observational study of Cerebral Palsy, run by Nursena Güçlü at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) describes a group of persistent disorders in movement and postural development that cause activity limitation, attributed to non-progressive disturbances occurring in the developing fetal or infant brain. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- observational
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2021to 20 May 2022
- How long will I take part?
- 14 Days
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients aged 4-18 years diagnosed with cerebral palsy
Who may be able to join
- 4 to 18 years of age
- Being diagnosed with cerebral palsy
- The GMFCS level was determined to be between I-IV.
Who cannot join
- The parent who will answer the form does not know Turkish.
- Performing orthopedic surgery and botulinum toxin injection in the previous six months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yeni Kurtuluş Özel Eğitim Ve Rehabilitasyon Merkezi
Ankara, Altındağ, 06230
About this study
Official title: valıdıty and relıabılıty of the turkısh versıon of the functıonal mobılıty Scale ın ındıvıduals wıth Cerebral Palsy (Fms)
Cerebral palsy (CP) describes a group of persistent disorders in movement and postural development that cause activity limitation, attributed to non-progressive disturbances occurring in the developing fetal or infant brain.
Motor disorders of cerebral palsy are often accompanied by sensory, perception, cognition, communication and behavioral disorders due to epilepsy and secondary musculoskeletal problems.(Rosenbaum et al. 2007) Within the ICF, body functions are the physiological functions of body systems and anatomical parts of the body, such as body structures, organs, limbs, and components.
Read more
Disorders are problems that appear as a significant deviation or loss in body functions or structure. The primary injury in CP is a brain lesion resulting from an upper motor neuron lesion that is thought to have a number of positive and negative features. Positive traits include spasticity, hyperreflexia, and co-contraction, while negative traits include weakness, loss of selective motor control, and balance and coordination deficits.
The aim of the study is to examine the validity and reliability of the Turkish version of the Functional Mobility Scale (FMS) in individuals with cerebral palsy.
Read the detailed description
GROSS MOTOR FUNCTİON CLASSİFİCATİON SYSTEM (GMFCS):
Level I: Walks without restrictions. Level II: Walks with restrictions. Level III: Walks using hand-held mobility devices. Level IV: Self-movement is limited. Can use a motorized mobility vehicle. Level V: Transported in a manual wheelchair. Differences Between Levels
Differences Between Levels I and II:
Compared to children/teens in Level I, children/teenagers in Level II have limitations in walking and balance. They may need hand-held mobility devices when they first learn to walk. They can use a wheeled mobility vehicle for long distance trips outside the home and in the community. They need the use of handrails when going up and down stairs. He does not have the ability to run and jump.
Differences Between Levels II and III:
Children and teenagers at Level II can walk without a hand-held mobility device after age 4 (although they prefer to use it occasionally). Children and youth in Level III use hand-held mobility devices to walk indoors and use wheeled mobility devices outside the home and in the community.
Differences Between Level III and IV:
Children and teenagers in Level III sit on their own or need very nervous external support to sit, are more independent in standing displacements, and walk with a hand-held mobility device. Children/teens at Level IV are functional seated (usually supported), but self-mobility is limited. Children and young people in Level IV are mostly transported in a manual wheelchair or use a motorized mobility vehicle.
Differences Between Levels IV and V:
Children and teenagers at Level V have severe limitations in bass and trunk control and need extensive technological and physical assistance. Self-mobility is gained only when the child/youth learns how to use a motorized wheelchair (2).
PEDİATRİC EVALUATİON OF DİSABİLİTY INVENTORY (PEDI):
Evaluates activities of daily living (self-care, mobility, social function) in children aged between 6 months and 7.5 years. PEDI is a comprehensive clinical assessment tool that assesses children's functional ability and performance. The first section, the Functional Skills Section, consists of 197 items and is a direct measurement of the child's functional abilities. In this section, the Self-Care subsection consists of 73 items, the Mobility subsection 59 and the Social Functions subsection 65 items. The child is given points as "0=cannot" and "1=can" for the items in this section. At the end of each subsection, the scores of that section are summed up and the functional skills (FB) total score is obtained by adding the scores of the subsections. The second and third sections evaluate the help and form of assistance from caregivers. It occurs in self-care, mobility, and social function items. Evaluation with the help of the caregiver is graded as independent, observation, minimum, moderate, maximum, complete. Adaptation evaluation is examined in 4 categories as no adaptation, adaptations for the child, rehabilitation tools and intensive adaptation. In this study, the mobility section will be used (3).
ABILOCO- KIDS:
It is a valid and reliable locomotion abilities scale defined on 10 items. ABILOCO-KIDS, which measures mobility, was translated into Turkish and applied. ABİLOCO-kids questionnaire consisting of ten questions was filled according to the information given by the parents. Questions are evaluated on a five-point scale. Impossible, difficult, easy, (unobserved activity). It can be applied to children aged 5 and over. (4)
FUNCTIONAL MOBILITY SCALE (FMS):
FMS classifies functional mobility in children with CP by grading the ability to walk at three specific distances, 5, 50, and 500 meters, according to the need for assistive devices. The scale includes various assistive devices such as wheelchairs, walkers, crutches and sticks, and also includes walking without the need for assistive devices. It uses a six-point ordinal scale (1-6) to rate the assistance needed at each distance reflecting distances from home, school, and community.
6 points, Independent on all surfaces. It does not use any walking aids or require the assistance of another person when walking on all surfaces, including uneven floors. (sidewalks etc. and in a crowded environment.)
5 points, Independent on flat surfaces. Does not use walking aids or need someone else's help. It needs handrails for stairs.
4 points, uses a cane (one or two). Walks without the help of another person.
3 points uses crutches without someone else's help.
2 points use walker without anyone else's help.
1 point, Uses a wheelchair. Can stop for transfers, take a few steps assisted by another person or using a walker.
C = Crawling: Child crawls (5m) to be able to move around the house.
N = not valid : For example, the child does not complete the distance ( 500 m ) .(1)
- Conditions
- Cerebral Palsy
- Being tested
- observational
- Keywords
- serebral palsi, GMFCS, Functional Mobility Scale, Abiloco-kids
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
The scales will be filled by asking the family.
| Study group | Role | What they receive |
|---|---|---|
| grup 1 | GMFCS PEDİ ABİLOCO-KİDS FMS Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional mobility scale
6 points, Independent on all surfaces. It does not use any walking aids or require the assistance of another person when walking on all surfaces, including uneven floors. (sidewalks etc. and in a crowded environment.)
5 points, Independent on flat surfaces. Does not use walking aids or need someone else's help. It needs handrails for stairs.
4 points, uses a cane (one or two). Walks without the help of another person.
3 points uses crutches without someone else's help.
2 points use walker without anyone else's help.
1 point, Uses a wheelchair. Can stop for transfers, take a few steps assisted by another person or using a walker.
C = Crawling: Child crawls (5m) to be able to move around the house.
N = not valid : For example the child does not complete the distance ( 500 m ) .
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start15 Sep 2021
- Primary completion30 Apr 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Nursena Güçlü
- Sponsor type
- University, hospital or other
- Collaborators
- Kırıkkale University
- Responsible party
- Sponsor-investigator, Nursena Güçlü, Kırıkkale University
- Investigators
- saniye arslan, Study director, kırıkkale üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145231
- Sponsor's protocol ID
- Kirikkaleüniversity3
- Acronym
- FMS
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2021
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- valıdıty and relıabılıty of the turkısh versıon of the functıonal mobılıty Scale ın ındıvıduals wıth Cerebral Palsy (Fms)
- ClinicalTrials.gov ID
- NCT05145231
- Acronym / sponsor ID
- FMS / Kirikkaleüniversity3
- Conditions
- Cerebral Palsy
- Keywords
- serebral palsi, GMFCS, Functional Mobility Scale, Abiloco-kids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Nursena GüçlüUniversity, hospital or other
- Collaborators
- Kırıkkale University
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 6 Dec 2021 (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.
Cerebral palsy (CP) describes a group of persistent disorders in movement and postural development that cause activity limitation, attributed to non-progressive disturbances occurring in the developing fetal or infant brain.
Motor disorders of cerebral palsy are often accompanied by sensory, perception, cognition, communication and behavioral disorders due to epilepsy and secondary musculoskeletal problems.(Rosenbaum et al. 2007) Within the ICF, body functions are the physiological functions of body systems and anatomical parts of the body, such as body structures, organs, limbs, and components.
Disorders are problems that appear as a significant deviation or loss in body functions or structure. The primary injury in CP is a brain lesion resulting from an upper motor neuron lesion that is thought to have a number of positive and negative features. Positive traits include spasticity, hyperreflexia, and co-contraction, while negative traits include weakness, loss of selective motor control, and balance and coordination deficits.
The aim of the study is to examine the validity and reliability of the Turkish version of the Functional Mobility Scale (FMS) in individuals with cerebral palsy.
Detailed description
GROSS MOTOR FUNCTİON CLASSİFİCATİON SYSTEM (GMFCS):
Level I: Walks without restrictions. Level II: Walks with restrictions. Level III: Walks using hand-held mobility devices. Level IV: Self-movement is limited. Can use a motorized mobility vehicle. Level V: Transported in a manual wheelchair. Differences Between Levels
Differences Between Levels I and II:
Compared to children/teens in Level I, children/teenagers in Level II have limitations in walking and balance. They may need hand-held mobility devices when they first learn to walk. They can use a wheeled mobility vehicle for long distance trips outside the home and in the community. They need the use of handrails when going up and down stairs. He does not have the ability to run and jump.
Differences Between Levels II and III:
Children and teenagers at Level II can walk without a hand-held mobility device after age 4 (although they prefer to use it occasionally). Children and youth in Level III use hand-held mobility devices to walk indoors and use wheeled mobility devices outside the home and in the community.
Differences Between Level III and IV:
Children and teenagers in Level III sit on their own or need very nervous external support to sit, are more independent in standing displacements, and walk with a hand-held mobility device. Children/teens at Level IV are functional seated (usually supported), but self-mobility is limited. Children and young people in Level IV are mostly transported in a manual wheelchair or use a motorized mobility vehicle.
Differences Between Levels IV and V:
Children and teenagers at Level V have severe limitations in bass and trunk control and need extensive technological and physical assistance. Self-mobility is gained only when the child/youth learns how to use a motorized wheelchair (2).
PEDİATRİC EVALUATİON OF DİSABİLİTY INVENTORY (PEDI):
Evaluates activities of daily living (self-care, mobility, social function) in children aged between 6 months and 7.5 years. PEDI is a comprehensive clinical assessment tool that assesses children's functional ability and performance. The first section, the Functional Skills Section, consists of 197 items and is a direct measurement of the child's functional abilities. In this section, the Self-Care subsection consists of 73 items, the Mobility subsection 59 and the Social Functions subsection 65 items. The child is given points as "0=cannot" and "1=can" for the items in this section. At the end of each subsection, the scores of that section are summed up and the functional skills (FB) total score is obtained by adding the scores of the subsections. The second and third sections evaluate the help and form of assistance from caregivers. It occurs in self-care, mobility, and social function items. Evaluation with the help of the caregiver is graded as independent, observation, minimum, moderate, maximum, complete. Adaptation evaluation is examined in 4 categories as no adaptation, adaptations for the child, rehabilitation tools and intensive adaptation. In this study, the mobility section will be used (3).
ABILOCO- KIDS:
It is a valid and reliable locomotion abilities scale defined on 10 items. ABILOCO-KIDS, which measures mobility, was translated into Turkish and applied. ABİLOCO-kids questionnaire consisting of ten questions was filled according to the information given by the parents. Questions are evaluated on a five-point scale. Impossible, difficult, easy, (unobserved activity). It can be applied to children aged 5 and over. (4)
FUNCTIONAL MOBILITY SCALE (FMS):
FMS classifies functional mobility in children with CP by grading the ability to walk at three specific distances, 5, 50, and 500 meters, according to the need for assistive devices. The scale includes various assistive devices such as wheelchairs, walkers, crutches and sticks, and also includes walking without the need for assistive devices. It uses a six-point ordinal scale (1-6) to rate the assistance needed at each distance reflecting distances from home, school, and community.
6 points, Independent on all surfaces. It does not use any walking aids or require the assistance of another person when walking on all surfaces, including uneven floors. (sidewalks etc. and in a crowded environment.)
5 points, Independent on flat surfaces. Does not use walking aids or need someone else's help. It needs handrails for stairs.
4 points, uses a cane (one or two). Walks without the help of another person.
3 points uses crutches without someone else's help.
2 points use walker without anyone else's help.
1 point, Uses a wheelchair. Can stop for transfers, take a few steps assisted by another person or using a walker.
C = Crawling: Child crawls (5m) to be able to move around the house.
N = not valid : For example, the child does not complete the distance ( 500 m ) .(1)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| grup 1 | – | Other: observationalGMFCS PEDİ ABİLOCO-KİDS FMS |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients aged 4-18 years diagnosed with cerebral palsy
Key inclusion criteria (3 listed)
- 4 to 18 years of age
- Being diagnosed with cerebral palsy
- The GMFCS level was determined to be between I-IV.
Key exclusion criteria (2 listed)
- The parent who will answer the form does not know Turkish.
- Performing orthopedic surgery and botulinum toxin injection in the previous six 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 |
|---|---|---|
| observationalThe scales will be filled by asking the family. | Other | grup 1 |
Primary outcome
functional mobility scale
Time frame: 2 week
6 points, Independent on all surfaces. It does not use any walking aids or require the assistance of another person when walking on all surfaces, including uneven floors. (sidewalks etc. and in a crowded environment.) 5 points, Independent on flat surfaces. Does not use walking aids or need someone else's help. It needs handrails for stairs. 4 points, uses a cane (one or two). Walks without the help of another person. 3 points uses crutches without someone else's help. 2 points use walker without anyone else's help. 1 point, Uses a wheelchair. Can stop for transfers, take a few steps assisted by another person or using a walker. C = Crawling: Child crawls (5m) to be able to move around the house. N = not valid : For example the child does not complete the distance ( 500 m ) .
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 27 Sep 2024.
- 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.
saniye arslan study director
kırıkkale üniversitesi
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 Cerebral Palsy, run by Nursena Güçlü 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 2 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 27 Sep 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 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?
functional mobility scale (time frame: 2 week). 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 27 Sep 2024.