HemiplegiaNCT02178371
Constraint Induced Movement Therapy on Infantile Hemiplegia
A study testing mCIMT and Unimanual therapy without constraint UTWC in people with Hemiplegia, run by CEU San Pablo University at 1 site in Spain.
Trial summary
The purpose of this study is to assess the functionality of the affected upper limb in infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- mCIMT and Unimanual therapy without constraint UTWC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Dec 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 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children's Hemiplegia Medical diagnosis.
- Aged between 4 and 8 years.
- Lack of activity of the affected upper extremity.
- Overcoming 10th extension at the metacarpophalangeal and interphalangeal joint.
- Complete the 20 º of wrist extension of the affected upper extremity.
- Adequate cognitive development to understand verbal commands given for the execution of tasks.
- Cooperation in the execution of tasks.
Who cannot join
- To Have vision problems that prevent them from carrying out the intervention.
- Having significant balance changes that endanger the child fall to bring a restriction in the affected upper limb.
- Submit uncontrolled seizures.
- To Have received botulinum toxin prior to 6 months prior to the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Modified Constraint Induced Movement Therapy on Infantile Hemiplegia
The purpose of this study is to assess the functionality of the affected upper limb in infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy.
- Conditions
- Hemiplegia
- Being tested
- mCIMT, Unimanual therapy without constraint UTWC
- Keywords
- Upper extremity, Physical therapy modalities
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCIMTProcedure or surgery
Also called Modified constraint-induced movement therapy
affected upper limb use with constraint of the healthy hand
Unimanual therapy without constraint UTWCProcedure or surgery
affected upper limb use without constraint of healthy hand
| Study group | Role | What they receive |
|---|---|---|
| UTWC (control group) | Experimental | the control group performs the same tasks than the experimental group, but without healthy hand constraint/containment. Receives: Procedure: Unimanual therapy without constraint UTWC |
| mCIMT | Experimental | The study is conducted over a period of 5 weeks of treatment, using a movement restriction time healthy upper extremity of 2 hours daily.
The restriction applied in the study is performed with the closed hand position and thumb inside the fist through a transparent film that reaches the wrist joint.
In periods mCIMT, monitored the activities designed to enhance their functionality, based on motivation, avoiding frustrations are made. Receives: Procedure: mCIMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the Quality of Upper Extremity Skills Test (QUEST) at week 5.
Measured: Baseline, week 5.
Change from baseline on the Shuee Evaluation at week 5
Measured: baseline, week 5
Secondary outcomes (3)
Change from baseline on visual-motor coordination at week 5.
Circuit described by Mak in 2010
Measured: Baseline, week 5.
Change from baseline on Grip strength at week 5.
Measured: Baseline, week 5.
Change from baseline on the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) at week 5.
Measured: Baseline, week 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rocio Palomo Carrión, PhD, PT, Principal investigator, San Pablo CEU UniversityFrancisco García-Muro SAn José, PhD, PT, Study director, San Pablo CEU University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178371
- Sponsor's protocol ID
- CEU-006
- Status last verified
- Jul 2020
- First submitted
- 26 Jun 2014
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified Constraint Induced Movement Therapy on Infantile Hemiplegia
- ClinicalTrials.gov ID
- NCT02178371
- Acronym / sponsor ID
- CEU-006
- Conditions
- Hemiplegia
- Keywords
- Upper extremity, Physical therapy modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 30 Jun 2014 (estimated)
- 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 purpose of this study is to assess the functionality of the affected upper limb in infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UTWC (control group) | Experimental | Procedure: Unimanual therapy without constraint UTWCthe control group performs the same tasks than the experimental group, but without healthy hand constraint/containment. |
| mCIMT | Experimental | Procedure: mCIMTThe study is conducted over a period of 5 weeks of treatment, using a movement restriction time healthy upper extremity of 2 hours daily. The restriction applied in the study is performed with the closed hand position and thumb inside the fist through a transparent film that reaches the wrist joint. In periods mCIMT, monitored the activities designed to enhance their functionality, based on motivation, avoiding frustrations are made. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children's Hemiplegia Medical diagnosis.
- Aged between 4 and 8 years.
- Lack of activity of the affected upper extremity.
- Overcoming 10th extension at the metacarpophalangeal and interphalangeal joint.
- Complete the 20 º of wrist extension of the affected upper extremity.
Key exclusion criteria (4 listed)
- To Have vision problems that prevent them from carrying out the intervention.
- Having significant balance changes that endanger the child fall to bring a restriction in the affected upper limb.
- Submit uncontrolled seizures.
- To Have received botulinum toxin prior to 6 months prior to the intervention.
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 |
|---|---|---|
| mCIMTAlso: Modified constraint-induced movement therapyaffected upper limb use with constraint of the healthy hand | Procedure or surgery | mCIMT |
| Unimanual therapy without constraint UTWCaffected upper limb use without constraint of healthy hand | Procedure or surgery | UTWC (control group) |
Primary outcome
Change from baseline on the Quality of Upper Extremity Skills Test (QUEST) at week 5.
Time frame: Baseline, week 5.
Change from baseline on the Shuee Evaluation at week 5
Time frame: baseline, week 5
3 secondary outcomes
Change from baseline on visual-motor coordination at week 5.
Time frame: Baseline, week 5.
Change from baseline on Grip strength at week 5.
Time frame: Baseline, week 5.
Change from baseline on the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) at week 5.
Time frame: Baseline, week 5.
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 Jul 2020.
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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.
Rocio Palomo Carrión, PhD, PT principal investigator
San Pablo CEU University
Francisco García-Muro SAn José, PhD, PT study director
San Pablo CEU 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 mCIMT and Unimanual therapy without constraint UTWC in people with Hemiplegia, run by CEU San Pablo University 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 7 inclusion and 4 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 Jul 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?
Change from baseline on the Quality of Upper Extremity Skills Test (QUEST) at week 5. (time frame: Baseline, week 5.). The study lists 2 primary outcomes in all. 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 Jul 2020.