Cerebral Palsy, SpasticNCT04694118
Comparison of the Effectiveness of Walking Back Exercises and Rebound Therapy in Cerebral Palsy Rehabilitation
A study testing rebound therapy in people with Cerebral Palsy, Spastic, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Purpose of the study: To investigate the effect of walking back exercises and rebound therapy on muscle strength, functionality, balance and aerobic capacity in children with CP Implication for rehabilitation:Determining the effects of rehabilitative interventions (back and forth walking exercises and rebound therapy)… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- What is being tested?
- rebound therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Jan 2021to 15 Dec 2021
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being diagnosed with hemiparetic SP To be in the age range of 6-15 years, where effective communication can be provided in evaluation and treatment processes and when walking begins to mature Having adequate communication skills Being on level I or level II according to KMFSS No impairment in visual functions in terms of not affecting postural control responses, Children with family consent
Who cannot join
- Orthopedic surgery and / or botulinum toxin-A application for the lower extremity in the last 6 months Being at level III, level IV or level V according to KMFSS Severe convulsion situations that cannot be controlled with drugs Presence of a medical condition that prevents participation in the study Congenital malformation conditions accompanying CP
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Umran medical center
Istanbul, Uskudar
ülkü atasoy, msc.pt, +905435796261, ulkuatasoy2017@gmail.com
- Recruiting
Ulku Atasoy
Istanbul, Ümraniye
ulku atasoy, msc.pt, +905435796261, ulkuatasoy2017@gmail.com
About this study
Purpose of the study:
To investigate the effect of walking back exercises and rebound therapy on muscle strength, functionality, balance and aerobic capacity in children with CP Implication for rehabilitation:Determining the effects of rehabilitative interventions (back and forth walking exercises and rebound therapy) to be applied in children with CP with objective measurement methods (muscle US, tetrax balance system) and evaluating the effects of the results on functionality and respiratory parameters
Read the detailed description
Inclusion Criteria:
Being diagnosed with SP To be in the age range of 6-15 years, where effective communication can be provided in evaluation and treatment processes and when walking begins to mature Having adequate communication skills Being on level I or level II according to GMFM No impairment in visual functions in terms of not affecting postural control responses, Children with family consent
Study design:
Application of the evaluation methods specified at the beginning of the study to all 30 patients with CP who were randomly divided into 2 groups.
Re-evaluations were planned 8 weeks after the first evaluation of all cases who were continuing with structured neurodevelopmental treatment programs. In addition to the ongoing structured neurodevelopmental treatment programs; Group 1: 12 weeks / 3 days 20 minutes walking back exercises on normal ground, Group 2: Rebound therapy exercises, which are arranged according to the functional levels of the cases, will be applied in 12 weeks / 3 days for 20 minutes.
- Conditions
- Cerebral Palsy, Spastic
- Being tested
- rebound therapy
- Keywords
- Cerebral palsy,, neurodevelopmental therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rebound therapyOther
Also called walking back exercise
3 days a week in 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 15 hemiparetic cerebral palsy,walking back group | Experimental | GMFM I or II degreed 6-15 age range hemiparetic cerebral palsy Receives: Other: rebound therapy |
| 15 hemiparetic cerebral palsy,rebound therapy group | Experimental | GMFM I or II degreed 6-15 age range hemiparetic cerebral palsy Receives: Other: rebound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in muscle volume
ultrasonic imaging
Measured: one measurement at the beginning of the study, second measurement 8 weeks later, 3rd measurement at 12th week following
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start4 Jan 2021
- Primary completion15 Dec 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomise controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ulkuatasoy2017, Istanbul Medipol University Hospital
- Investigators
- ulku atasoy, msc.pt, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694118
- Sponsor's protocol ID
- 10840098-604.01.01-E.66352
- Status last verified
- Jan 2021
- First submitted
- 1 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Walking Back Exercises and Rebound Therapy in Cerebral Palsy Rehabilitation
- ClinicalTrials.gov ID
- NCT04694118
- Acronym / sponsor ID
- 10840098-604.01.01-E.66352
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- Cerebral palsy,, neurodevelopmental therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 15 Dec 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 5 Jan 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.
Purpose of the study:
To investigate the effect of walking back exercises and rebound therapy on muscle strength, functionality, balance and aerobic capacity in children with CP Implication for rehabilitation:Determining the effects of rehabilitative interventions (back and forth walking exercises and rebound therapy) to be applied in children with CP with objective measurement methods (muscle US, tetrax balance system) and evaluating the effects of the results on functionality and respiratory parameters
Detailed description
Inclusion Criteria:
Being diagnosed with SP To be in the age range of 6-15 years, where effective communication can be provided in evaluation and treatment processes and when walking begins to mature Having adequate communication skills Being on level I or level II according to GMFM No impairment in visual functions in terms of not affecting postural control responses, Children with family consent
Study design:
Application of the evaluation methods specified at the beginning of the study to all 30 patients with CP who were randomly divided into 2 groups.
Re-evaluations were planned 8 weeks after the first evaluation of all cases who were continuing with structured neurodevelopmental treatment programs. In addition to the ongoing structured neurodevelopmental treatment programs; Group 1: 12 weeks / 3 days 20 minutes walking back exercises on normal ground, Group 2: Rebound therapy exercises, which are arranged according to the functional levels of the cases, will be applied in 12 weeks / 3 days for 20 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomise controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| 15 hemiparetic cerebral palsy,walking back group | Experimental | Other: rebound therapyGMFM I or II degreed 6-15 age range hemiparetic cerebral palsy |
| 15 hemiparetic cerebral palsy,rebound therapy group | Experimental | Other: rebound therapyGMFM I or II degreed 6-15 age range hemiparetic cerebral palsy |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Being diagnosed with hemiparetic SP To be in the age range of 6-15 years, where effective communication can be provided in evaluation and treatment processes and when walking begins to mature Having adequate communication skills Being on level I or level II according to KMFSS No impairment in visual functions in terms of not affecting postural control responses, Children with family consent
Key exclusion criteria (1 listed)
- Orthopedic surgery and / or botulinum toxin-A application for the lower extremity in the last 6 months Being at level III, level IV or level V according to KMFSS Severe convulsion situations that cannot be controlled with drugs Presence of a medical condition that prevents participation in the study Congenital malformation conditions accompanying CP
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 |
|---|---|---|
| rebound therapyAlso: walking back exercise3 days a week in 12 weeks | Other | 15 hemiparetic cerebral palsy,rebound therapy group, 15 hemiparetic cerebral palsy,walking back group |
Primary outcome
changes in muscle volume
Time frame: one measurement at the beginning of the study, second measurement 8 weeks later, 3rd measurement at 12th week following
ultrasonic imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Cerebral Palsy, Spastic
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Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
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Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
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Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic 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.
ulku atasoy, msc.pt principal investigator
PhD student
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rebound therapy in people with Cerebral Palsy, Spastic, run by Istanbul Medipol University Hospital at 2 sites 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 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 devrim tarakcı, assoc.prof. (4448544 ext. 1890, dtarakci@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in muscle volume (time frame: one measurement at the beginning of the study, second measurement 8 weeks later, 3rd measurement at 12th week following). 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 6 Jan 2021.