Cerebral PalsyCPNCT04136678
The Effect of Treadmill Back Walking Training on Balance and Function in Cerebral Palsy
A study testing walking training in people with Cerebral Palsy, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of treadmill back walking training on balance and function in cerebral palsy. In our study, scientific data will be prepared by clinical measurement tools in order to determine whether there is balance and walking effect of easy and practicable treadmill back walking… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- walking training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2018to 10 Oct 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Those who are between 6 and 18 years old and have a medical report on the diagnosis of cerebral palsy,
- Classes classified as Level I and II by Gross Motor Function Classification System (GMFCS),
- Lower extremity spasticity classified as 1st and 2nd degree according to Modified Modified Ashworth Scale,
- To understand and apply verbal commands and instructions.
- Volunteer to participate in the study,
- Read and approve the informed consent form.
Who cannot join
- Active epileptic seizures
- Those with visual or auditory defects,
- Those with fixed deformities in the lower extremities,
- Patients with a history of surgery in the lower extremity musculoskeletal system in the last 6 months
- Injection of Botulinum Toxin (BOTOX) for lower extremity within the last 6 months Spasticity drug users,
- Those with mental and cognitive problems will be excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Halkalı, Yükselen Başarı, Abı Hayat, Altın, Özlem and Çocuklarla Elele Education and Rehabilitation Center.
Istanbul, (535) 020-6774
About this study
The aim of this study was to investigate the effect of treadmill back walking training on balance and function in cerebral palsy.
In our study, scientific data will be prepared by clinical measurement tools in order to determine whether there is balance and walking effect of easy and practicable treadmill back walking training in the clinical setting in Cerebral Palsy.
Read the detailed description
Measurements will be made at baseline and after each 8 weeks of physiotherapy program, the results will be compared.
30 minutes of the physiotherapy session, which we will apply for 2 days and 45 minutes; in the prone, supine, crawling and above knee positions; They will take physiotherapy training based on neurodevelopmental therapy consisting of fine motor activities, standing up, weight transfer, stretching, strengthening and balance exercises with mat activities such as rotation, weight transfer, sitting.
- Term: After the first measurements, the participants will take 8 minutes, 2 days a week, the regular physiotherapy session based on 30 minutes Neurodevelopmental Therapy as described above, as well as 15 minutes conventional walking training, then the measurements will be repeated.
- Term: After the second measurements, the participants will take 8 weeks, 2 days a week, the regular physiotherapy session based on 30 minutes of Neurodevelopmental Therapy as described above, as well as 15 minutes of treadmill back walking training, then the measurements will be repeated.
- Term: After the third measurements, the participants will take 8 weeks, 2 days a week, the regular physiotherapy session based on the 30 minute Neurodevelopmental Therapy described above, as well as the 15-minute treadmill walking forward training, then the measurements will be repeated.
Statistical method (s) to be used: In the analysis of the results to be obtained in our study, SPS statistics 22.0 version of SPSS statistical package will be used under the Windows operating system Statistical Package for Social Sciences (SPSS). Descriptive statistical information will be shown as arithmetic mean ± Standard Deviation (x statistical ± Ss) or percentage (%) and the level of statistical significance will be considered as p≤0.05.
- Conditions
- Cerebral Palsy
- Being tested
- walking training
- Keywords
- cerebral palsy, treadmill, backward walking, balance, spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking trainingOther
Also called conventional walking training, treadmill backward walking training, treadmill forward walking training
15 minutes of conventional walking training 15 minutes of treadmill backward walking training 15 minutes of treadmil forward walking training
| Study group | Role | What they receive |
|---|---|---|
| treadmill back walking training | Experimental | 15 minutes conventional walking training, 15 minutes of treadmill back walking training, 15-minute treadmill forward walking training Receives: Other: walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pediatric Balance Scale
It can be considered as a simple, valid scale for studying functional balance capacity in children with spastic SP (Yi 2012). Pediatric Berg Balance Scale (PBBS) will be used to evaluate the functional balance of daily living activities. Higher scores mean a better outcome.
Measured: 8 weeks
Secondary outcomes (1)
The Rivermead Visual Gait Assessment
RVGA allows rapid assessment and documentation of gait disturbances without equipment in the clinic and demonstration of clinical changes (Lord, et al. 1998). Visual parameters of walking in our study will be evaluated by The Rivermead Visual Gait Assessment (RVGA). Higher scores mean a worse outcome.
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 posted23 Oct 2019
- Study start15 Nov 2018
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Those who are between 6 and 18 years old and have a medical report on the diagnosis of cerebral palsy,
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, halis dogan, Istanbul Medipol University Hospital
- Investigators
- H D Doğan, Pt, Principal investigator, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136678
- Sponsor's protocol ID
- halisdogan
- Acronym
- CP
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Treadmill Back Walking Training on Balance and Function in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04136678
- Acronym / sponsor ID
- CP / halisdogan
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, treadmill, backward walking, balance, spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 23 Oct 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.
The aim of this study was to investigate the effect of treadmill back walking training on balance and function in cerebral palsy.
In our study, scientific data will be prepared by clinical measurement tools in order to determine whether there is balance and walking effect of easy and practicable treadmill back walking training in the clinical setting in Cerebral Palsy.
Detailed description
Measurements will be made at baseline and after each 8 weeks of physiotherapy program, the results will be compared.
30 minutes of the physiotherapy session, which we will apply for 2 days and 45 minutes; in the prone, supine, crawling and above knee positions; They will take physiotherapy training based on neurodevelopmental therapy consisting of fine motor activities, standing up, weight transfer, stretching, strengthening and balance exercises with mat activities such as rotation, weight transfer, sitting.
- Term: After the first measurements, the participants will take 8 minutes, 2 days a week, the regular physiotherapy session based on 30 minutes Neurodevelopmental Therapy as described above, as well as 15 minutes conventional walking training, then the measurements will be repeated.
- Term: After the second measurements, the participants will take 8 weeks, 2 days a week, the regular physiotherapy session based on 30 minutes of Neurodevelopmental Therapy as described above, as well as 15 minutes of treadmill back walking training, then the measurements will be repeated.
- Term: After the third measurements, the participants will take 8 weeks, 2 days a week, the regular physiotherapy session based on the 30 minute Neurodevelopmental Therapy described above, as well as the 15-minute treadmill walking forward training, then the measurements will be repeated.
Statistical method (s) to be used: In the analysis of the results to be obtained in our study, SPS statistics 22.0 version of SPSS statistical package will be used under the Windows operating system Statistical Package for Social Sciences (SPSS). Descriptive statistical information will be shown as arithmetic mean ± Standard Deviation (x statistical ± Ss) or percentage (%) and the level of statistical significance will be considered as p≤0.05.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Those who are between 6 and 18 years old and have a medical report on the diagnosis of cerebral palsy,
| Arm | Type | Receives |
|---|---|---|
| treadmill back walking training | Experimental | Other: walking training15 minutes conventional walking training, 15 minutes of treadmill back walking training, 15-minute treadmill forward walking training |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Those who are between 6 and 18 years old and have a medical report on the diagnosis of cerebral palsy,
- Classes classified as Level I and II by Gross Motor Function Classification System (GMFCS),
- Lower extremity spasticity classified as 1st and 2nd degree according to Modified Modified Ashworth Scale,
- To understand and apply verbal commands and instructions.
- Volunteer to participate in the study,
Key exclusion criteria (6 listed)
- Active epileptic seizures
- Those with visual or auditory defects,
- Those with fixed deformities in the lower extremities,
- Patients with a history of surgery in the lower extremity musculoskeletal system in the last 6 months
- Injection of Botulinum Toxin (BOTOX) for lower extremity within the last 6 months Spasticity drug users,
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 |
|---|---|---|
| walking trainingAlso: conventional walking training, treadmill backward walking training, treadmill forward walking training15 minutes of conventional walking training 15 minutes of treadmill backward walking training 15 minutes of treadmil forward walking training | Other | treadmill back walking training |
Primary outcome
The Pediatric Balance Scale
Time frame: 8 weeks
It can be considered as a simple, valid scale for studying functional balance capacity in children with spastic SP (Yi 2012). Pediatric Berg Balance Scale (PBBS) will be used to evaluate the functional balance of daily living activities. Higher scores mean a better outcome.
1 secondary outcome
The Rivermead Visual Gait Assessment
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 12 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
H D Doğan, Pt principal investigator
Istanbul Medipol University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking training in people with Cerebral Palsy, run by Istanbul Medipol University Hospital 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 6 inclusion and 6 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 12 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?
The Pediatric Balance Scale (time frame: 8 weeks). 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 12 Feb 2020.