Hemiplegia; CongenitalNCT04425980
The Efficacy of Two Models of Intensive Upper Limb Training on Quality of Life in Children With Congenital Hemiplegia
A study testing Modified Constraint-Induced Movement Therapy in people with Hemiplegia; Congenital, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
This study compared the effectiveness of two-mode of activity-based upper limb rehabilitation (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related quality of life outcomes in school-aged children with cerebral palsy Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia; Congenital
- What is being tested?
- Modified Constraint-Induced Movement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 15 Feb 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical diagnosis of congenital hemiplegia,
- Must be able to grasp objects
Who cannot join
- Cerebral palsy dependent severe emotional difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Two Models of Intensive Upper Limb Training On Quality of Life in Children With Hemiplegic Cerebral Palsy Attending Regular School in Mus Province: A Randomized Controlled Trial
This study compared the effectiveness of two-mode of activity-based upper limb rehabilitation (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related quality of life outcomes in school-aged children with cerebral palsy
Read the detailed description
A total of 52 primary schools were screened comprehensively to determine children conforming specifications of the inclusion criteria. Demographic characteristics (e.g. age, gender, affected side) and severity of functional impairment dealing with cognitive /communication, manual ability and mobility were noted. After a comprehensive screening, a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (Modified Constraint-Induced Movement Therapy or Bimanual training), at an equal number and probability. Children blinded to group allocation were delivered activity-based upper limb training in the context of Modified Constraint-Induced Movement Therapy or Bimanual training, at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3 sessions per week was carried out in the school time (during the art or physical education class), while 2 out of 3 sessions were carried out in rehabilitation centers which the children regularly attend for regular care 2-day weekly. All participating children continued to receive their standard care (90 minutes per week) throughout the study period.
During the 1-month screening period, physical characteristics of participants were described through classification systems including The Communication Function Classification System, The Manual Ability Classification System , and The Gross Motor Function Classification System. Participating children were evaluated before the study entry (T1), immediately postintervention (T2), and at 16 weeks postintervention (T3) using the KIDSCREEN-27 questionnaire
- Conditions
- Hemiplegia; Congenital
- Being tested
- Modified Constraint-Induced Movement Therapy
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Constraint-Induced Movement TherapyOther
intensive use of more affected arm in structured setting
| Study group | Role | What they receive |
|---|---|---|
| Modified Constraint-Induced Movement Therapy (test treatments) | Experimental | A list of fine and motor activities consisted of the functional tasks or play activities such as school-education and sports activities, manipulative games, arts, and crafts, etc. to elicit the maximum capacity of the more affected upper limb was created according to the procedure of modified constraint-induced movement therapy (Gordon et al., 2005) and Bimanual training. In addition, specific activities were also chosen in terms of deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request. 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 a role as a dominant hand Receives: Other: Modified Constraint-Induced Movement Therapy |
| Bimanual training | Active comparator | For the Bimanual training, skilled, repetitive, and structured bimanual activities (part or whole task practice) were used to promote bimanual hand use and improve movement deficits determined before the intervention. All targeted deficits of interest were addressed within the context of the selected activity. Specifically, symmetrical bilateral movements were utilized to augment neural input from both sides. Also, meaningful activities such as buttoning and zipping-up trousers, etc. were used to ensure a transition from structured setting to real-life activities Receives: Other: Modified Constraint-Induced Movement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention
The KIDSCREEN instruments have been established to report various subdomains of QOL about physical, emotional, mental and social well-being in school-aged children and adolescents
Measured: From baeline to post-intervention, up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Oct 2018
- Primary completion15 Jul 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia; CongenitalStudies 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
- a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (modified constraint-induced movement therapy or Bimanual training), at an equal number and probability
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 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 UniversityMintaze Kerem Günel, PhD, Study chair, Hacettepe UniversityHalil ALKAN, PhD, Principal investigator, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425980
- Sponsor's protocol ID
- no any sponsor
- Status last verified
- Mar 2021
- First submitted
- 5 Jun 2020
- Last updated
- 9 Mar 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Two Models of Intensive Upper Limb Training On Quality of Life in Children With Hemiplegic Cerebral Palsy Attending Regular School in Mus Province: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04425980
- Acronym / sponsor ID
- no any sponsor
- Conditions
- Hemiplegia; Congenital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 11 Jun 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 compared the effectiveness of two-mode of activity-based upper limb rehabilitation (Modified Constraint-Induced Movement Therapy and Bimanual training) on health-related quality of life outcomes in school-aged children with cerebral palsy
Detailed description
A total of 52 primary schools were screened comprehensively to determine children conforming specifications of the inclusion criteria. Demographic characteristics (e.g. age, gender, affected side) and severity of functional impairment dealing with cognitive /communication, manual ability and mobility were noted. After a comprehensive screening, a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (Modified Constraint-Induced Movement Therapy or Bimanual training), at an equal number and probability. Children blinded to group allocation were delivered activity-based upper limb training in the context of Modified Constraint-Induced Movement Therapy or Bimanual training, at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3 sessions per week was carried out in the school time (during the art or physical education class), while 2 out of 3 sessions were carried out in rehabilitation centers which the children regularly attend for regular care 2-day weekly. All participating children continued to receive their standard care (90 minutes per week) throughout the study period.
During the 1-month screening period, physical characteristics of participants were described through classification systems including The Communication Function Classification System, The Manual Ability Classification System , and The Gross Motor Function Classification System. Participating children were evaluated before the study entry (T1), immediately postintervention (T2), and at 16 weeks postintervention (T3) using the KIDSCREEN-27 questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (modified constraint-induced movement therapy or Bimanual training), at an equal number and probability
| Arm | Type | Receives |
|---|---|---|
| Modified Constraint-Induced Movement Therapy (test treatments) | Experimental | Other: Modified Constraint-Induced Movement TherapyA list of fine and motor activities consisted of the functional tasks or play activities such as school-education and sports activities, manipulative games, arts, and crafts, etc. to elicit the maximum capacity of the more affected upper limb was created according to the procedure of modified constraint-induced movement therapy (Gordon et al., 2005) and Bimanual training. In addition, specific activities were also chosen in terms of deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request. 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 a role as a dominant hand |
| Bimanual training | Active comparator | Other: Modified Constraint-Induced Movement TherapyFor the Bimanual training, skilled, repetitive, and structured bimanual activities (part or whole task practice) were used to promote bimanual hand use and improve movement deficits determined before the intervention. All targeted deficits of interest were addressed within the context of the selected activity. Specifically, symmetrical bilateral movements were utilized to augment neural input from both sides. Also, meaningful activities such as buttoning and zipping-up trousers, etc. were used to ensure a transition from structured setting to real-life activities |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinical diagnosis of congenital hemiplegia,
- Must be able to grasp objects
Key exclusion criteria (1 listed)
- Cerebral palsy dependent severe emotional difficulties
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 Therapyintensive use of more affected arm in structured setting | Other | Bimanual training, Modified Constraint-Induced Movement Therapy (test treatments) |
Primary outcome
Change from baseline in quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention
Time frame: From baeline to post-intervention, up to 16 weeks
The KIDSCREEN instruments have been established to report various subdomains of QOL about physical, emotional, mental and social well-being in school-aged children and adolescents
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.
- Individual participant dataSharing planned: No
Related trials for Hemiplegia; Congenital
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
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Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
Children With Hemiplegic cp
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Recruiting
Implementation of Therapy Together
Cerebral Palsy, Hemiplegic Cerebral Palsy
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
Mintaze Kerem Günel, PhD study chair
Hacettepe University
Halil ALKAN, PhD 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 in people with Hemiplegia; Congenital, 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 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 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 quality of life on the 5 point KIDSCREEN-27 questionnaire at post intervention (time frame: From baeline to post-intervention, up to 16 weeks). 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 9 Mar 2021.