Hemiplegia, InfantileNCT04284176
Movement in the Non-use of the Affected Upper Extremity in Children Hemiparesis: Mirror Therapy and Action-observation
A study testing Mirror therapy and action-observation therapy in people with Hemiplegia, Infantile, run by CEU San Pablo University at 1 site in Spain.
Trial summary
Children with cerebral palsy hemiplegia present a restriction in the daily activities due to the limitation in the active movement of the affected upper extremity. The mirror therapy (MT) in children with hemiparesis produces an improvement in the quality of movement and in the perception of the affected upper… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Hemiplegia, Infantile
- What is being tested?
- Mirror therapy and action-observation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2019to 30 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with hemiparesia.
- From 6 to 12 years,
- A spontaneous use of the hand according to the scale HOUSE, a level MACS I-III
- A good cooperation and cognition
Who cannot join
- Severe spasticity
- Previous surgery of the upper extremity
- The use of botox
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
CEU-San Pablo Universtiy
Madrid, 28922
Juan Carlos Zuil-Escobar, PhD, 913724700, jczuil@ceu.es
About this study
Official title: Influence of the Quality of Movement in the "Non-use" of the Upper Extremity Affected in Children Hemiparesis: Mirror Therapy and Action-observation as Therapeutic Strategies
Children with cerebral palsy hemiplegia present a restriction in the daily activities due to the limitation in the active movement of the affected upper extremity.
The mirror therapy (MT) in children with hemiparesis produces an improvement in the quality of movement and in the perception of the affected upper extremity. The action-observation therapy (AOT) favors the motor behaviour of the affected upper extremity through the observation of sequences of systematic activities and their posterior execution. It also produces an increase in the excitability of the corticospinal tract, originating muscular pattern contraction similar to the observed ones and favoring the motor activity.
Read more
The combination of both therapies might improve the quality of movement of the upper extremity and provide a major cortical activation and increase the spontaneous use on having created the only protocol of intervention which includes the benefits of both interventions.
The principal aim of this study is to analyze the influence of the quality of movement in the spontaneous use of the upper extremity affected in children with hemiparesis as well as the improvement of both variables across MTAO. Another specific aim will be to determine if "the non-use" is determined by the quality of the movement of the segment, if the MTAO reduces "the non-use" of this extremity as well as to obtain a protocol of intervention that increases the quality of movement and the spontaneous long-term use.
A randomized controlled trial will be carry out in children with hemiparesia between 6 and 12 years, with a spontaneous use of the hand according to the scale HOUSE, a level Manual Ability Classification System (MASC) I-III and a good cooperation and cognition. Those with a severe spasticity, previous surgery of the upper extremity and the use of botox will be excluded. The children will be divided in two groups. The experimental group will receive for 20 days a daily therapy of 15 minutes at home of MT and 45 of AOT, whereas the control group will receive 60 minutes of AOT.
Four measurements will be obtained: basal situation, at the end of the treatment and measures of follow-up to 3 and 6 months after the end of the treatment. Despite the sociodemographic variables, measures of the quality of the movement, the spontaneous use of the upper extremity, the questionnaire CHEQ and the AHA scale.
Read the detailed description
Two protocols are designed to be carried out at home. The AOT protocol includes 15 set of daily life upper limb uni/bimanual activities (8 sets for bimanual activities and 7 sets for unimanual activities).
The MTAO group include 6 mirror therapy activities and the same activities that are included in the AOT protocol.
A pilot study will be conducted for sample size calculation, assessing the AHA and Jebsen-Taylor scales, before and immediately after the intervention.
- Conditions
- Hemiplegia, Infantile
- Being tested
- Mirror therapy and action-observation therapy
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror therapy and action-observation therapyOther
The mirror therapy and action-observation therapy group will receive for 20 days a daily therapy of 15 minutes at home of MT and 45 of AOT, whereas the action-observation therapy group will receive 60 minutes of AOT.
| Study group | Role | What they receive |
|---|---|---|
| Mirrow therapy and action-observation therapy | Experimental | The intervention include 20 hours, applied during a four-week period (1 hour per day from Monday to Friday) at home. The first 15 minutes will include myrror therapy 6 activities and the remaing 45 minutes both unimanual and bimanual action-observation therapy activities. Receives: Other: Mirror therapy and action-observation therapy |
| Action-observation therapy | Experimental | The intervention include 20 hours, applied during a four-week period (1 hour per day from Monday to Friday) at home. There protocol includes both unimanual and bimanual action-observation therapy activities. Receives: Other: Mirror therapy and action-observation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the affected hand and arm in bimanual performance assess by Assisting Hand Assessment (AHA) scale
AHA scale includes several domains: general use, arm use, grasp-release, fine motor adjustments, coordination and rhythm. 22 items are scored and converted to 0-100 logit-based AHA units.
Measured: 6 months
Functionality of the affected hand assess by Jensen-Taylor scale
The Jebsen-Taylor scale includes 7 subtests: writing, card turning, picking up small objects, stacking checkers, stimulated feeding, moving lights objects, moving heavy objects. Normative data are described for adults, but not for children.
Measured: 6 months
Experience of children in the use of the affected hand during activities where two hands are usually required assess by the Children's Hand-use Experience Questionnaire (CHEQ).
The CHEQ questionnaire ask about some activities that typically require the use of both hands. The results are converted into logits using Rasch analysis.
Measured: 6 months
Grip strength assess by hand grip dynamometer
Hand grip dynamometer
Measured: 6 months
Muscular activity of the wrist muscles assess by Surface electromyography (EMG)
Surface EMG
Measured: 6 months
Range of motion of the wrist assess by goniometer and goniometer app
Goniometer and goniometer app
Measured: 6 months
Secondary outcomes (1)
correlation between range of motion of the wrist assessed by goniometer and goniometer app
To assess the correlation of the range of motion evaluated by universal goniometer and goniometer app
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start20 Sep 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia, InfantileStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan-Carlos Zuil-Escobar, PhD, Principal investigator, CEU San Pablo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284176
- Sponsor's protocol ID
- CEUSPU
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2020
- Last updated
- 19 Apr 2021
- 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 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Quality of Movement in the "Non-use" of the Upper Extremity Affected in Children Hemiparesis: Mirror Therapy and Action-observation as Therapeutic Strategies
- ClinicalTrials.gov ID
- NCT04284176
- Acronym / sponsor ID
- CEUSPU
- Conditions
- Hemiplegia, Infantile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 25 Feb 2020 (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.
Children with cerebral palsy hemiplegia present a restriction in the daily activities due to the limitation in the active movement of the affected upper extremity.
The mirror therapy (MT) in children with hemiparesis produces an improvement in the quality of movement and in the perception of the affected upper extremity. The action-observation therapy (AOT) favors the motor behaviour of the affected upper extremity through the observation of sequences of systematic activities and their posterior execution. It also produces an increase in the excitability of the corticospinal tract, originating muscular pattern contraction similar to the observed ones and favoring the motor activity.
The combination of both therapies might improve the quality of movement of the upper extremity and provide a major cortical activation and increase the spontaneous use on having created the only protocol of intervention which includes the benefits of both interventions.
The principal aim of this study is to analyze the influence of the quality of movement in the spontaneous use of the upper extremity affected in children with hemiparesis as well as the improvement of both variables across MTAO. Another specific aim will be to determine if "the non-use" is determined by the quality of the movement of the segment, if the MTAO reduces "the non-use" of this extremity as well as to obtain a protocol of intervention that increases the quality of movement and the spontaneous long-term use.
A randomized controlled trial will be carry out in children with hemiparesia between 6 and 12 years, with a spontaneous use of the hand according to the scale HOUSE, a level Manual Ability Classification System (MASC) I-III and a good cooperation and cognition. Those with a severe spasticity, previous surgery of the upper extremity and the use of botox will be excluded. The children will be divided in two groups. The experimental group will receive for 20 days a daily therapy of 15 minutes at home of MT and 45 of AOT, whereas the control group will receive 60 minutes of AOT.
Four measurements will be obtained: basal situation, at the end of the treatment and measures of follow-up to 3 and 6 months after the end of the treatment. Despite the sociodemographic variables, measures of the quality of the movement, the spontaneous use of the upper extremity, the questionnaire CHEQ and the AHA scale.
Detailed description
Two protocols are designed to be carried out at home. The AOT protocol includes 15 set of daily life upper limb uni/bimanual activities (8 sets for bimanual activities and 7 sets for unimanual activities).
The MTAO group include 6 mirror therapy activities and the same activities that are included in the AOT protocol.
A pilot study will be conducted for sample size calculation, assessing the AHA and Jebsen-Taylor scales, before and immediately after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirrow therapy and action-observation therapy | Experimental | Other: Mirror therapy and action-observation therapyThe intervention include 20 hours, applied during a four-week period (1 hour per day from Monday to Friday) at home. The first 15 minutes will include myrror therapy 6 activities and the remaing 45 minutes both unimanual and bimanual action-observation therapy activities. |
| Action-observation therapy | Experimental | Other: Mirror therapy and action-observation therapyThe intervention include 20 hours, applied during a four-week period (1 hour per day from Monday to Friday) at home. There protocol includes both unimanual and bimanual action-observation therapy activities. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with hemiparesia.
- From 6 to 12 years,
- A spontaneous use of the hand according to the scale HOUSE, a level MACS I-III
- A good cooperation and cognition
Key exclusion criteria (3 listed)
- Severe spasticity
- Previous surgery of the upper extremity
- The use of botox
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 |
|---|---|---|
| Mirror therapy and action-observation therapyThe mirror therapy and action-observation therapy group will receive for 20 days a daily therapy of 15 minutes at home of MT and 45 of AOT, whereas the action-observation therapy group will receive 60 minutes of AOT. | Other | Action-observation therapy, Mirrow therapy and action-observation therapy |
Primary outcome
Effectiveness of the affected hand and arm in bimanual performance assess by Assisting Hand Assessment (AHA) scale
Time frame: 6 months
AHA scale includes several domains: general use, arm use, grasp-release, fine motor adjustments, coordination and rhythm. 22 items are scored and converted to 0-100 logit-based AHA units.
Functionality of the affected hand assess by Jensen-Taylor scale
Time frame: 6 months
The Jebsen-Taylor scale includes 7 subtests: writing, card turning, picking up small objects, stacking checkers, stimulated feeding, moving lights objects, moving heavy objects. Normative data are described for adults, but not for children.
Experience of children in the use of the affected hand during activities where two hands are usually required assess by the Children's Hand-use Experience Questionnaire (CHEQ).
Time frame: 6 months
The CHEQ questionnaire ask about some activities that typically require the use of both hands. The results are converted into logits using Rasch analysis.
Grip strength assess by hand grip dynamometer
Time frame: 6 months
Hand grip dynamometer
Muscular activity of the wrist muscles assess by Surface electromyography (EMG)
Time frame: 6 months
Surface EMG
Range of motion of the wrist assess by goniometer and goniometer app
Time frame: 6 months
Goniometer and goniometer app
1 secondary outcome
correlation between range of motion of the wrist assessed by goniometer and goniometer app
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Hemiplegia, Infantile
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Using Power Mobility Training to Promote Arm & Hand Function in Children With Cerebral Palsy
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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.
Juan-Carlos Zuil-Escobar, PhD principal investigator
CEU San Pablo 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 Mirror therapy and action-observation therapy in people with Hemiplegia, Infantile, 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 4 inclusion and 3 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 19 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan-Carlos Zuil-Escobar, PhD (+34616442143, jczuil@ceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the affected hand and arm in bimanual performance assess by Assisting Hand Assessment (AHA) scale (time frame: 6 months). The study lists 6 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 19 Apr 2021.