Cerebral PalsyNCT04577391
Comparing the Effectiveness of mCIMT and Bimanual Training
A study testing Modified Constraint-Induced Movement Therapy and Bimanual Training in people with Cerebral Palsy, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the effects of Modified Constraint-Induced Movement Therapy (mCIMT) and Bimanual Training (BIT) based on the International Classification of Functioning, Disability, and Health, Children \&Youth (ICF-CY) conceptual framework. Read more about this study
- Who is it for?
- Ages 7 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Modified Constraint-Induced Movement Therapy and Bimanual Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2018to 15 Apr 2020
- 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 7 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical diagnosis of spastic hemiplegic cerebral palsy
- Must be able to attend primary or secondary school
Who cannot join
- Family-dependent problems interfering with participation in study sessions
- The presence of behavioral problems interfering with the assessment periods or intervention sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effects of Modified Constraint-Induced Movement Therapy and Bimanual Training in Children With Hemiplegic Cerebral Palsy Mainstreamed in Regular School: A Randomized Controlled Study
This study aimed to compare the effects of Modified Constraint-Induced Movement Therapy (mCIMT) and Bimanual Training (BIT) based on the International Classification of Functioning, Disability, and Health, Children \&Youth (ICF-CY) conceptual framework. Our assumptions were that (1) mCIMT is more effective on outcomes representing all subdomains of ICF and (2) the possible improvements in the body structure and function, activity, and participation subdomains of ICF are intimately related to each other.
Read the detailed description
Thirty-two children with spastic hemiplegic cerebral palsy (mean age 10.43 years [SD 2.9 years]; 15 females, 17 males) whose functional profiles associated with Manual Ability Classification System, Gross Motor Function Classification System, and Communication Function Classification System changed between level I-III were randomly distributed to one of the mCIMT or BIT groups with equivalent dosing frequency and intensity (10 weeks/3 days per week/2.5 hours per day). Outcome measures categorized according to the domains of International Classification of Functioning, Disability, and Health, Children \&Youth (ICF-CY) framework were used to document body functions, activity, and participation outcomes. Assessments were carried out before (T1) and after treatment (T2), and at 16 weeks post-intervention (T3) by a physical therapist blinded to group allocation. Before the study entry, informed consent was obtained from the parents. General and specific contents related to each intervention were delivered as individual sessions at the school (one session per week) or group sessions with two participants at rehabilitation centers (two sessions per week).
- Conditions
- Cerebral Palsy
- Being tested
- Modified Constraint-Induced Movement Therapy, Bimanual Training
- Keywords
- upper limb, hand, bimanual training, constraint-induced movement therapy, ICF-CY, hemiplegic 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.
Modified Constraint-Induced Movement TherapyOther
Children's less affected hand was restricted through a mitt with a material sewn shut on the palmar face to promote the involved side's use, and unimanual gross and fine motor activities were practiced with the more affected hand. Besides, if the participant attempted to use his/her less affected hand as an assistive, a bandage was also used to strap less affected upper limb to the trunk. Specific activities were selected according to the deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request (e.g., drawing, painting, and eating).
Bimanual TrainingOther
BIT was administrated without any restrictive material on the non-involved upper limb, but instead, children were engaged in age-appropriate gross and fine motor bimanual activities. All targeted deficits of interest were addressed within the context of the selected activity.
| Study group | Role | What they receive |
|---|---|---|
| Modified Constraint-Induced Movement Therapy | Experimental | Children's less affected hand was restricted through a mitt with a material sewn shut on the palmar face to promote the use of involved side as maximum as possible. Besides, if the participant attempted to use his/her less affected hand as an assistive, a bandage was also used to strap less affected upper limb to the trunk. Specific activities were selected according to deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request (e.g., drawing, painting, and eating). In case of activities requiring both hand use, such as stabilizing paper during the painting or holding the bricks of lego on the ground, the treating physiotherapist undertook the role of the child's dominant hand. Receives: Other: Modified Constraint-Induced Movement Therapy |
| Bimanual training | Active comparator | BIT was administrated without any restrictive material on the non-involved upper limb, but instead, children were engaged in age-appropriate gross and fine motor bimanual activities. All targeted deficits of interest were addressed within the context of the selected activity. Receives: Other: Bimanual Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in unimanual capacity on Upper Extremity Skills Test (QUEST) at 16 weeks
The Upper Extremity Skills Test (QUEST) is a criterion-referenced measurement tool, developed to evaluate upper extremity quality of movement in children with cerebral palsy.The Upper Extremity Skills Test has been validated for children with cerebral palsy aged 18 months to 12 years. Intra-rater reliability of the QUEST has been indicated to strong (ICC=0.96) in children with cerebral palsy aged eight and over.
Measured: Baseline and week 16
Change from baseline in manual ability on ABILHAND-Kids at 16 weeks
ABILHAND-Kids is developed for children with cerebral palsy and measures a child's ability to manage 21 daily activities that require the use of the upper limbs. It measures the children's typical performance in daily life. ABILHAND-Kids is useful in reporting the functional performance of children with one affected side in the perspective of manual ability and has excellent test-retest reliability for Turkish children with cerebral palsy (ICC=0. 0.98)
Measured: Baseline and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start15 Oct 2018
- Primary completion15 Jan 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Model description
- Randomized controlled trial: Work consisting of a clinical trial that involves at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Bingöl, Muş Alparslan University
- Investigators
- Hasan Bingöl, MSc, Principal investigator, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577391
- Sponsor's protocol ID
- 79236777-050.01.04
- Status last verified
- Mar 2021
- First submitted
- 24 Sep 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fedrizzi E, Rosa-Rizzotto M, Turconi AC, Pagliano E, Fazzi E, Pozza LV, Facchin P; GIPCI Study Group. Unimanual and bimanual intensive training in children with hemiplegic cerebral palsy and persistence in time of hand function improvement: 6-month follow-up results of a multisite clinical trial. J Child Neurol. 2013 Feb;28(2):161-75. doi: 10.1177/0883073812443004. Epub 2012 May 10.
PubMed 22580904Gelkop 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, Ziviani J, Boyd RN. Best responders after intensive upper-limb training for children with unilateral cerebral palsy. Arch Phys Med Rehabil. 2011 Apr;92(4):578-84. doi: 10.1016/j.apmr.2010.12.003.
PubMed 21440702Thompson AM, Chow S, Vey C, Lloyd M. Constraint-induced movement therapy in children aged 5 to 9 years with cerebral palsy: a day camp model. Pediatr Phys Ther. 2015 Spring;27(1):72-80. doi: 10.1097/PEP.0000000000000111.
PubMed 25521268Bingol H, Gunel MK. Comparing the effects of modified constraint-induced movement therapy and bimanual training in children with hemiplegic cerebral palsy mainstreamed in regular school: A randomized controlled study. Arch Pediatr. 2022 Feb;29(2):105-115. doi: 10.1016/j.arcped.2021.11.017. Epub 2022 Jan 14.
PubMed 35039189
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Modified Constraint-Induced Movement Therapy and Bimanual Training in Children With Hemiplegic Cerebral Palsy Mainstreamed in Regular School: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04577391
- Acronym / sponsor ID
- 79236777-050.01.04
- Conditions
- Cerebral Palsy
- Keywords
- upper limb, hand, bimanual training, constraint-induced movement therapy, ICF-CY, hemiplegic cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 6 Oct 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.
This study aimed to compare the effects of Modified Constraint-Induced Movement Therapy (mCIMT) and Bimanual Training (BIT) based on the International Classification of Functioning, Disability, and Health, Children \&Youth (ICF-CY) conceptual framework. Our assumptions were that (1) mCIMT is more effective on outcomes representing all subdomains of ICF and (2) the possible improvements in the body structure and function, activity, and participation subdomains of ICF are intimately related to each other.
Detailed description
Thirty-two children with spastic hemiplegic cerebral palsy (mean age 10.43 years [SD 2.9 years]; 15 females, 17 males) whose functional profiles associated with Manual Ability Classification System, Gross Motor Function Classification System, and Communication Function Classification System changed between level I-III were randomly distributed to one of the mCIMT or BIT groups with equivalent dosing frequency and intensity (10 weeks/3 days per week/2.5 hours per day). Outcome measures categorized according to the domains of International Classification of Functioning, Disability, and Health, Children \&Youth (ICF-CY) framework were used to document body functions, activity, and participation outcomes. Assessments were carried out before (T1) and after treatment (T2), and at 16 weeks post-intervention (T3) by a physical therapist blinded to group allocation. Before the study entry, informed consent was obtained from the parents. General and specific contents related to each intervention were delivered as individual sessions at the school (one session per week) or group sessions with two participants at rehabilitation centers (two sessions per week).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial: Work consisting of a clinical trial that involves at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table
| Arm | Type | Receives |
|---|---|---|
| Modified Constraint-Induced Movement Therapy | Experimental | Other: Modified Constraint-Induced Movement TherapyChildren's less affected hand was restricted through a mitt with a material sewn shut on the palmar face to promote the use of involved side as maximum as possible. Besides, if the participant attempted to use his/her less affected hand as an assistive, a bandage was also used to strap less affected upper limb to the trunk. Specific activities were selected according to deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request (e.g., drawing, painting, and eating). In case of activities requiring both hand use, such as stabilizing paper during the painting or holding the bricks of lego on the ground, the treating physiotherapist undertook the role of the child's dominant hand. |
| Bimanual training | Active comparator | Other: Bimanual TrainingBIT was administrated without any restrictive material on the non-involved upper limb, but instead, children were engaged in age-appropriate gross and fine motor bimanual activities. All targeted deficits of interest were addressed within the context of the selected activity. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of spastic hemiplegic cerebral palsy
- Must be able to attend primary or secondary school
Key exclusion criteria (2 listed)
- Family-dependent problems interfering with participation in study sessions
- The presence of behavioral problems interfering with the assessment periods or intervention sessions
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 |
|---|---|---|
| Modified Constraint-Induced Movement TherapyChildren's less affected hand was restricted through a mitt with a material sewn shut on the palmar face to promote the involved side's use, and unimanual gross and fine motor activities were practiced with the more affected hand. Besides, if the participant attempted to use his/her less affected hand as an assistive, a bandage was also used to strap less affected upper limb to the trunk. Specific activities were selected according to the deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request (e.g., drawing, painting, and eating). | Other | Modified Constraint-Induced Movement Therapy |
| Bimanual TrainingBIT was administrated without any restrictive material on the non-involved upper limb, but instead, children were engaged in age-appropriate gross and fine motor bimanual activities. All targeted deficits of interest were addressed within the context of the selected activity. | Other | Bimanual training |
Primary outcome
Change from baseline in unimanual capacity on Upper Extremity Skills Test (QUEST) at 16 weeks
Time frame: Baseline and week 16
The Upper Extremity Skills Test (QUEST) is a criterion-referenced measurement tool, developed to evaluate upper extremity quality of movement in children with cerebral palsy.The Upper Extremity Skills Test has been validated for children with cerebral palsy aged 18 months to 12 years. Intra-rater reliability of the QUEST has been indicated to strong (ICC=0.96) in children with cerebral palsy aged eight and over.
Change from baseline in manual ability on ABILHAND-Kids at 16 weeks
Time frame: Baseline and week 16
ABILHAND-Kids is developed for children with cerebral palsy and measures a child's ability to manage 21 daily activities that require the use of the upper limbs. It measures the children's typical performance in daily life. ABILHAND-Kids is useful in reporting the functional performance of children with one affected side in the perspective of manual ability and has excellent test-retest reliability for Turkish children with cerebral palsy (ICC=0. 0.98)
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 9 Mar 2021.
- Results publication: PubMed 22580904Fedrizzi E, Rosa-Rizzotto M, Turconi AC, Pagliano E, Fazzi E, Pozza LV, Facchin P; GIPCI Study Group. Unimanual and bimanual intensive training in children with hemiplegic cerebral palsy and persistence in time of hand function improvement: 6-month follow-up results of a multisite clinical trial. J Child Neurol. 2013 Feb;28(2):161-75. doi: 10.1177/0883073812443004. Epub 2012 May 10.
- 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 21440702Sakzewski L, Ziviani J, Boyd RN. Best responders after intensive upper-limb training for children with unilateral cerebral palsy. Arch Phys Med Rehabil. 2011 Apr;92(4):578-84. doi: 10.1016/j.apmr.2010.12.003.
- Results publication: PubMed 25521268Thompson AM, Chow S, Vey C, Lloyd M. Constraint-induced movement therapy in children aged 5 to 9 years with cerebral palsy: a day camp model. Pediatr Phys Ther. 2015 Spring;27(1):72-80. doi: 10.1097/PEP.0000000000000111.
- Derived from this study: PubMed 35039189Bingol H, Gunel MK. Comparing the effects of modified constraint-induced movement therapy and bimanual training in children with hemiplegic cerebral palsy mainstreamed in regular school: A randomized controlled study. Arch Pediatr. 2022 Feb;29(2):105-115. doi: 10.1016/j.arcped.2021.11.017. Epub 2022 Jan 14.
- 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.
Hasan Bingöl, MSc principal investigator
Muş Alparslan 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 Modified Constraint-Induced Movement Therapy and Bimanual Training in people with Cerebral Palsy, run by Muş Alparslan University at 1 site 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 2 inclusion and 2 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 9 Mar 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 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?
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 in unimanual capacity on Upper Extremity Skills Test (QUEST) at 16 weeks (time frame: Baseline and week 16). 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?
On the ClinicalTrials.gov record for NCT04577391, which also lists 5 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 9 Mar 2021.