Cerebral PalsyNCT03521427
Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children
A study testing Intensive bimanual therapy and Intensive neurodevelopmental therapy in people with Cerebral Palsy, run by University of Alcala at 1 site in Spain.
Trial summary
The aim of the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in Cerebral Palsy patients. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Intensive bimanual therapy and Intensive neurodevelopmental therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jul 2017to 3 Feb 2018
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cerebral Palsy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in Cerebral Palsy patients.
Read the detailed description
The aim of the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in Cerebral Palsy patients. Also to know paretns and caregivers perceptions.
- Conditions
- Cerebral Palsy
- Being tested
- Intensive bimanual therapy, Intensive neurodevelopmental therapy
- Keywords
- Intensive Therapy, Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive bimanual therapyOther
Ninety hours of intensive bimanual therapy
Intensive neurodevelopmental therapyOther
Ninety hours of intensive neurodevelopmental therapy
| Study group | Role | What they receive |
|---|---|---|
| Intensive bimanual therapy | Experimental | Ninety hours of intensive bimanual therapy Receives: Other: Intensive bimanual therapy |
| Neurodevelopmental treatment | Active comparator | Ninety hours of intensive neurodevelopmental therapy Receives: Other: Intensive neurodevelopmental therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Funtion
Assissting Hand Assessment Instrument (AHA)
Measured: 6 months
Secondary outcomes (2)
Funtional Activity
Jebsen Taylor Hand Funtion Test
Measured: 6 months
Perception of performance in everyday living
Canadian Occupational Performance Measure (COMP)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start14 Jul 2017
- Primary completion3 Aug 2017
- Study completion3 Feb 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Collaborators
- European University Spain
- Responsible party
- Principal investigator, Isabel Rodriguez Costa, University of Alcala
- Investigators
- Andrew Gordon, PhD, Study director, Columbia Universuty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521427
- Sponsor's protocol ID
- R-0066/16
- Status last verified
- May 2018
- First submitted
- 29 Jun 2017
- Last updated
- 11 May 2018
- 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 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Upper and Lower Limbs Motor Control Therapy in Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT03521427
- Acronym / sponsor ID
- R-0066/16
- Conditions
- Cerebral Palsy
- Keywords
- Intensive Therapy, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Collaborators
- European University Spain
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 3 Feb 2018 (actual)
- First posted
- 11 May 2018 (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 the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in Cerebral Palsy patients.
Detailed description
The aim of the study is to determine the effetiveness of the intensive upper and lower limbs therapy to improve the funtional outcomes and to minimize ther energetic spendings during funtional activities in Cerebral Palsy patients. Also to know paretns and caregivers perceptions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive bimanual therapy | Experimental | Other: Intensive bimanual therapyNinety hours of intensive bimanual therapy |
| Neurodevelopmental treatment | Active comparator | Other: Intensive neurodevelopmental therapyNinety hours of intensive neurodevelopmental therapy |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Cerebral Palsy
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Intensive bimanual therapyNinety hours of intensive bimanual therapy | Other | Intensive bimanual therapy |
| Intensive neurodevelopmental therapyNinety hours of intensive neurodevelopmental therapy | Other | Neurodevelopmental treatment |
Primary outcome
Arm Funtion
Time frame: 6 months
Assissting Hand Assessment Instrument (AHA)
2 secondary outcomes
Funtional Activity
Time frame: 6 months
Perception of performance in everyday living
Time frame: 6 months
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 11 May 2018.
- 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.
Andrew Gordon, PhD study director
Columbia Universuty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive bimanual therapy and Intensive neurodevelopmental therapy in people with Cerebral Palsy, run by University of Alcala at 1 site in Spain.
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: finished, as of the sponsor's last update on 11 May 2018. 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 Spain. 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?
Arm Funtion (time frame: 6 months). 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 11 May 2018.