Infantile HemiplegiaCIMT/BITNCT03465046
Intensive Therapies in Children With Hemiplegia
A study testing intensive therapies(CIMT/BIT): protocol 1 or protocol 2 in people with Infantile Hemiplegia, run by University of Salamanca at 1 site in Spain.
Trial summary
This is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Infantile Hemiplegia
- What is being tested?
- intensive therapies(CIMT/BIT): protocol 1 or protocol 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2018to 30 Jan 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with Unilateral Infantile Cerebral Palsy, Congenital Infantile Hemiparesis.
- Ages between 5 to 10 years.
- Levels of I-III within the , manual ability classification system, MACS.
- Levels of I-III within the gross motor function classification system, GMFCS
Who cannot join
- Diseases not associated with infantile hemiparesis.
- Low cognitive level to understand the execution of activities.
- Surgeries of the upper extremity during the 6 months prior to the intervention.
- Structured contractures in the affected upper extremity that cause functional impotence.
- Botulinum toxin two months prior to the intervention and application of it during the treatment.
- Epilepsy not controlled pharmacologically
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modified Constraint Induced Movement Therapy and Bimanual Intensive Therapy in Children With Hemiplegia. Comparative Study
This is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life.
Read the detailed description
the intervention protocols combine different doses of intensive therapy, being 80 hours of modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol 2 would be the application of protocol 1 inverted, with this, the investigators want to compare how both protocols interfere in the function of the affected upper limb of children with different levels of bimanual functional performance.
- Conditions
- Infantile Hemiplegia
- Being tested
- intensive therapies(CIMT/BIT): protocol 1 or protocol 2
- Keywords
- infantile hemiplegia, upper extremity, physical therapy
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive therapies(CIMT/BIT): protocol 1 or protocol 2Combination product
The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses.
the protocols were carried out at home through the family
| Study group | Role | What they receive |
|---|---|---|
| low performance group 1 | Experimental | Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy Receives: Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2 |
| low performance group 2 | Experimental | Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy Receives: Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2 |
| moderate-high performance group1 | Experimental | Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy Receives: Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2 |
| moderate-high performance group 2 | Experimental | Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy Receives: Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
bimanual functional performance, "change" is being assessed
use of the affected upper extremity of spontaneous character during bimanual activities. It is used the AHA assessment to measure it.
Measured: 4 assessments will be carried out in the research in 10 weeks
Secondary outcomes (1)
quality of life ,"change" is being assessed
This measure will be assessed with the pedsQL questionnaire
Measured: 4 assessments will be carried out in the research in 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start15 Oct 2018
- Primary completion25 Nov 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Infantile HemiplegiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Palomo Carrión, University of Salamanca
- Investigators
- Rocío Palomo Carrión, Principal investigator, Salamanca University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465046
- Sponsor's protocol ID
- nº11, thesis SDDB USAL
- Acronym
- CIMT/BIT
- Status last verified
- Nov 2020
- First submitted
- 1 Mar 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tervahauta MH, Girolami GL, Oberg GK. Efficacy of constraint-induced movement therapy compared with bimanual intensive training in children with unilateral cerebral palsy: a systematic review. Clin Rehabil. 2017 Nov;31(11):1445-1456. doi: 10.1177/0269215517698834. Epub 2017 Mar 20.
PubMed 29050511Klepper SE, Clayton Krasinski D, Gilb MC, Khalil N. Comparing Unimanual and Bimanual Training in Upper Extremity Function in Children With Unilateral Cerebral Palsy. Pediatr Phys Ther. 2017 Oct;29(4):288-306. doi: 10.1097/PEP.0000000000000438.
PubMed 28953170Zafer H, Amjad I, Malik AN, Shaukat E. Effectiveness of Constraint induced movement therapy as compared to bimanual therapy in Upper motor function outcome in child with hemiplegic Cerebral palsy. Pak J Med Sci. 2016 Jan-Feb;32(1):181-4. doi: 10.12669/pjms.321.8491.
PubMed 27022371Geerdink Y, Aarts P, van der Burg J, Steenbergen B, Geurts A. Intensive upper limb intervention with self-management training is feasible and promising for older children and adolescents with unilateral cerebral palsy. Res Dev Disabil. 2015 Aug-Sep;43-44:97-105. doi: 10.1016/j.ridd.2015.06.013. Epub 2015 Jul 9.
PubMed 26164301Gelkop N, Burshtein DG, Lahav A, Brezner A, Al-Oraibi S, Ferre CL, Gordon AM. Efficacy of constraint-induced movement therapy and bimanual training in children with hemiplegic cerebral palsy in an educational setting. Phys Occup Ther Pediatr. 2015 Feb;35(1):24-39. doi: 10.3109/01942638.2014.925027. Epub 2014 Jul 1.
PubMed 24983295Sakzewski L, Gordon A, Eliasson AC. The state of the evidence for intensive upper limb therapy approaches for children with unilateral cerebral palsy. J Child Neurol. 2014 Aug;29(8):1077-90. doi: 10.1177/0883073814533150. Epub 2014 May 11.
PubMed 24820334Palomo-Carrion R, Ferri-Morales A, Ando-LaFuente S, Fernandez RA, Arenillas JIC, Anton-Anton V, Esteban EB. Constraint-induced movement therapy versus bimanual intensive therapy in children with hemiplegia showing low/very low bimanual functional performance: A randomized clinical trial. PM R. 2023 Dec;15(12):1536-1546. doi: 10.1002/pmrj.12990. Epub 2023 Jun 19.
PubMed 37139775Palomo-Carrion R, Lirio-Romero C, Ferri-Morales A, Jovellar-Isiegas P, Cortes-Vega MD, Romay-Barrero H. Combined intensive therapies at home in spastic unilateral cerebral palsy with high bimanual functional performance. What do they offer? A comparative randomised clinical trial. Ther Adv Chronic Dis. 2021 Aug 12;12:20406223211034996. doi: 10.1177/20406223211034996. eCollection 2021.
PubMed 34408823
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Constraint Induced Movement Therapy and Bimanual Intensive Therapy in Children With Hemiplegia. Comparative Study
- ClinicalTrials.gov ID
- NCT03465046
- Acronym / sponsor ID
- CIMT/BIT / nº11, thesis SDDB USAL
- Conditions
- Infantile Hemiplegia
- Keywords
- infantile hemiplegia, upper extremity, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 25 Nov 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 14 Mar 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.
This is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life.
Detailed description
the intervention protocols combine different doses of intensive therapy, being 80 hours of modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol 2 would be the application of protocol 1 inverted, with this, the investigators want to compare how both protocols interfere in the function of the affected upper limb of children with different levels of bimanual functional performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low performance group 1 | Experimental | Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy |
| low performance group 2 | Experimental | Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy |
| moderate-high performance group1 | Experimental | Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy |
| moderate-high performance group 2 | Experimental | Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children diagnosed with Unilateral Infantile Cerebral Palsy, Congenital Infantile Hemiparesis.
- Ages between 5 to 10 years.
- Levels of I-III within the , manual ability classification system, MACS.
- Levels of I-III within the gross motor function classification system, GMFCS
Key exclusion criteria (6 listed)
- Diseases not associated with infantile hemiparesis.
- Low cognitive level to understand the execution of activities.
- Surgeries of the upper extremity during the 6 months prior to the intervention.
- Structured contractures in the affected upper extremity that cause functional impotence.
- Botulinum toxin two months prior to the intervention and application of it during the treatment.
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 therapies(CIMT/BIT): protocol 1 or protocol 2The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses. the protocols were carried out at home through the family | Combination product | low performance group 1, low performance group 2, moderate-high performance group 2, moderate-high performance group1 |
Primary outcome
bimanual functional performance, "change" is being assessed
Time frame: 4 assessments will be carried out in the research in 10 weeks
use of the affected upper extremity of spontaneous character during bimanual activities. It is used the AHA assessment to measure it.
1 secondary outcome
quality of life ,"change" is being assessed
Time frame: 4 assessments will be carried out in the research in 10 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 4 Nov 2020.
- Results publication: PubMed 29050511Tervahauta MH, Girolami GL, Oberg GK. Efficacy of constraint-induced movement therapy compared with bimanual intensive training in children with unilateral cerebral palsy: a systematic review. Clin Rehabil. 2017 Nov;31(11):1445-1456. doi: 10.1177/0269215517698834. Epub 2017 Mar 20.
- Results publication: PubMed 28953170Klepper SE, Clayton Krasinski D, Gilb MC, Khalil N. Comparing Unimanual and Bimanual Training in Upper Extremity Function in Children With Unilateral Cerebral Palsy. Pediatr Phys Ther. 2017 Oct;29(4):288-306. doi: 10.1097/PEP.0000000000000438.
- Results publication: PubMed 27022371Zafer H, Amjad I, Malik AN, Shaukat E. Effectiveness of Constraint induced movement therapy as compared to bimanual therapy in Upper motor function outcome in child with hemiplegic Cerebral palsy. Pak J Med Sci. 2016 Jan-Feb;32(1):181-4. doi: 10.12669/pjms.321.8491.
- Results publication: PubMed 26164301Geerdink Y, Aarts P, van der Burg J, Steenbergen B, Geurts A. Intensive upper limb intervention with self-management training is feasible and promising for older children and adolescents with unilateral cerebral palsy. Res Dev Disabil. 2015 Aug-Sep;43-44:97-105. doi: 10.1016/j.ridd.2015.06.013. Epub 2015 Jul 9.
- Results publication: PubMed 24983295Gelkop N, Burshtein DG, Lahav A, Brezner A, Al-Oraibi S, Ferre CL, Gordon AM. Efficacy of constraint-induced movement therapy and bimanual training in children with hemiplegic cerebral palsy in an educational setting. Phys Occup Ther Pediatr. 2015 Feb;35(1):24-39. doi: 10.3109/01942638.2014.925027. Epub 2014 Jul 1.
- Results publication: PubMed 24820334Sakzewski L, Gordon A, Eliasson AC. The state of the evidence for intensive upper limb therapy approaches for children with unilateral cerebral palsy. J Child Neurol. 2014 Aug;29(8):1077-90. doi: 10.1177/0883073814533150. Epub 2014 May 11.
- Derived from this study: PubMed 37139775Palomo-Carrion R, Ferri-Morales A, Ando-LaFuente S, Fernandez RA, Arenillas JIC, Anton-Anton V, Esteban EB. Constraint-induced movement therapy versus bimanual intensive therapy in children with hemiplegia showing low/very low bimanual functional performance: A randomized clinical trial. PM R. 2023 Dec;15(12):1536-1546. doi: 10.1002/pmrj.12990. Epub 2023 Jun 19.
- Derived from this study: PubMed 34408823Palomo-Carrion R, Lirio-Romero C, Ferri-Morales A, Jovellar-Isiegas P, Cortes-Vega MD, Romay-Barrero H. Combined intensive therapies at home in spastic unilateral cerebral palsy with high bimanual functional performance. What do they offer? A comparative randomised clinical trial. Ther Adv Chronic Dis. 2021 Aug 12;12:20406223211034996. doi: 10.1177/20406223211034996. eCollection 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Infantile Hemiplegia
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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.
Rocío Palomo Carrión principal investigator
Salamanca University
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 therapies(CIMT/BIT): protocol 1 or protocol 2 in people with Infantile Hemiplegia, run by University of Salamanca 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 4 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 4 Nov 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 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?
bimanual functional performance, "change" is being assessed (time frame: 4 assessments will be carried out in the research in 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03465046, which also lists 8 linked publications.
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 4 Nov 2020.