Spastic Hemiplegic Cerebral PalsyNCT04064788
Modified Constraint-Induced Movement Therapy in Children With Hemiparetic Cerebral Palsy
A study testing Consecutive Modified Constraint-Induced Movement Therapy, Traditional physiotherapy and Intermittent Modified Constraint-Induced Movement Therapy in people with Spastic Hemiplegic Cerebral Palsy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) is defined as a non-progressive lesion of the developing foetal or infant brain and causes variety of motor, sensory and cognitive impairments. Hemiplegic CP is the most common type of CP in term infants, involving one half of the body. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Spastic Hemiplegic Cerebral Palsy
- What is being tested?
- Consecutive Modified Constraint-Induced Movement Therapy, Traditional physiotherapy and Intermittent Modified Constraint-Induced Movement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 8 Jan 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- confirmed diagnosis of hemiplegic CP
- 5-18 years of age
- MACS level I, II or III
- GMFCS level I
- To have sufficient communication skills
- To be able to extend the wrist at least 20 degrees
Show all 10Show fewer
- Lack of severe spasticity to prevent grasping and dropping objects
- Surgery or application of Botulinum toxin within the last 6 months
- The family's acceptance of the child's participation in the study
- The child volunteers to participate in the study
Who cannot join
- Visual and hearing impairment
- Family refuses to participate in the study
- There is a walking and balance problem that may cause a fall risk during the use of a sling
- Behavioral problems at the level to reject the practices to be performed within the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Modified Constraint-Induced Movement Therapy Administered on Consecutive or Intermittent Days on Upper Extremity Function in Individuals With Hemiparetic Cerebral Palsy
Cerebral palsy (CP) is defined as a non-progressive lesion of the developing foetal or infant brain and causes variety of motor, sensory and cognitive impairments. Hemiplegic CP is the most common type of CP in term infants, involving one half of the body. In these individuals, muscle tone is reduced, and there is an inability to perform quality upper extremity movements due to increased muscle tone, increased reflexes, weakness in antagonist muscles. Due to spasticity upper extremity is present in shoulder adduction and internal rotation, elbow flexion and pronation, wrist and fingers flexed and thumb in palm position. Spontaneous movements of the upper extremity are decreased and abnormal. These individuals have a reduced upper extremity function ranging from mild incompetence to almost no use of the hand.
Constraint-Induced Movement Therapy (CIMT) is designed to improve the function of the most affected limb by restricting the use of the less affected limb in individuals with unilateral upper extremity involvement and implementing an intensive motor learning-based training program. In pediatric subjects, modified CIMT (mCIMT), which is called a 'child-friendly technique', has been applied, which shows some differences from the form of CIMT in adults. In mCIMT, the restriction time was reduced, activities with the child were performed within a play frame, in the environment in which the child was accustomed, and restriction methods such as gloves, splint, sling were used. In the literature CIMT has been used mainly in children with hemiplegic CP in the pediatric population. However, there are many studies in the literature evaluating the efficacy of mCIMT in individuals with hemiplegic CP and showing beneficial effects on upper extremity speed and skills, and the duration of application restriction varies considerably.
The aim of the investigator's study was to determine the effect of consecutive or intermittent implementation of mCIMT on upper extremity function in children with hemiplegic CP. Thus, it will be determined whether the modification of the duration of administration in the pediatric population varies in treatment results.
Read the detailed description
33 children with spastic hemiplegia age between 5-18 years will participate study. Children's gross motor skills classified with Gross Motor Classification Sysytem (GMFCS) and hand abilities classified with Manual Ability Classification System (MACS). The children divided into 3 groups, consecutive mCIMT group, intermittent mCIMT group, and traditional physiotherapy control group. The consecutive mCIMT group received mCIMT treatment for 10 consecutive days in addition to the conventional physiotherapy sessions. A sling used to restrict the noninvolved upper extremity. The unaffected upper extremities of the children restricted for 6 hours and activities performed by using shaping techniques under the guidance of same therapist. Within the remaining period, the family implemented the activities with his/her child that are determined by the therapist using the motor learning principles, appropriate to the age of the child and that he / she likes to do. The assessments performed for all three groups before, 10 days after and 5 weeks after treatment.
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Being tested
- Consecutive Modified Constraint-Induced Movement Therapy, Traditional physiotherapy, Intermittent Modified Constraint-Induced Movement Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consecutive Modified Constraint-Induced Movement TherapyOther
Consecutive mCIMT group received 6 hours per day mCIMT sessions for consecutive 10 days. Accompanied by a physiotherapist in 1 hour of the 6-hour restriction period, the family was guided within the remaining period and the activities were adapted to daily life.
Traditional physiotherapyOther
Traditional physiotherapy within a specific program
Intermittent Modified Constraint-Induced Movement TherapyOther
Intermittent mCIMT group received mCIMT session 6 hours per day for 10 days, spread over 5 weeks (two days per week). Accompanied by a physiotherapist in 1 hour of the 6-hour restriction period, the family was guided within the remaining period and the activities were adapted to daily life.
| Study group | Role | What they receive |
|---|---|---|
| Consecutive mCIMT group | Experimental | 6 hours / day, 10 consecutive days, 60 hours mKZHT + 2 days 45 minutes / day traditional physiotherapy Receives: Other: Consecutive Modified Constraint-Induced Movement Therapy |
| Intermittent mCIMT group | Experimental | 6 hours / day 2 days a week 5 weeks, a total of 60 hours mKZHT + 2 days 45 min / day traditional physiotherapy Receives: Other: Intermittent Modified Constraint-Induced Movement Therapy |
| Traditional physiotherapy control group | Active comparator | 45 min / day, 2 days a week traditional physiotherapy Receives: Other: Traditional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Hand-Use Experience Questionnaire (CHEQ)
Assessing children's experience of using the affected hand in activities of daily living where usually two hands are needed. There are 29 items at questionnaire. When respondents answered the questionnaire, they were first asked whether the activity included in the questionnaire was conducted independently. If the activities can be done independently, it is questioned whether one or two hands are used during the activities. If two hands are used, answers and scores to the following 3 sub-questions are sought: hand use, time use in comparison to peers, experience of feeling bothered while doing the activity. A higher score indicates a better level of independence.
Measured: Change from Baseline at 10 days and at 5 weeks
Jebsen-Taylor Hand Function Test
This is an objective test to evaluate hand function for a person's activities of daily living. Test consist of 7 subtests includes writing, card turning, manipulate small common objects, simulated feeding, stacking checkers, moving large light objects and moving large heavy objects. We will use 6 subtests except writing in our study.
Measured: Change from Baseline at 10 days and at 5 weeks
Secondary outcomes (7)
Gross Motor Classification System (GMFCS)
This is a classification system for children with chronic disability and based on the movements initiated by the child him/herself such as sitting, moving and acting. GMFCS classifies gross motor functions of children with CP in five levels.
Measured: At Baseline
Manual Ability Classification System (MACS)
MACS is a five-level classification system that analyzes the children with CP use their hands while carrying objects in their daily activities.
Measured: At Baseline
Pediatric Balance Scale (PBS)
Assesses children's balance and consist of 14 items. Each item is scored between 0 and 4 points. Low score refers to the poor balance and the high score refers to the good balance.
Measured: At Baseline
Modified Tardieu Scale (MTS)
The scale was developed to evaluate spasticity. This scale reveals the rate-dependent nature of spasticity (27). Muscle reaction quality (X) and muscle reaction angle (Y) are determined with MTS. When measuring the muscle reaction angle, the goniometer is used to measure the position of the muscle with minimum stretching. If quality of muscle reaction score was 2 or higher, the joint angle in which the muscle responds with difficulty will be measured goniometer. The scales scores range from 0 to 5. 0= no resistance to passive movement. 1= slight resistance throughout the course of the passive movement. 2= there's a clear catching at a precise angle, which makes passive movement difficult, followed by a release. 3= fatigable clonus (Less than 10 seconds). 4= infatigable clonus (More than 10 seconds). 5= the joint cannot be moved. Evaluations are made in thre
Measured: Change from Baseline at 10 days and at 5 weeks
ABILHAND-Kids Questionnaire
Evaluates manual ability in children with cerebral palsy. Questionnaire consist of 21 bimanual items. Each item graded three levels (0=impossible, 1= difficult, 2= easy) and lower scores indicate lower ability of the hand or upper extremity.
Measured: Change from Baseline at 10 days and at 5 weeks
Surface electromyography (sEMG)
sEMG evaluates electrical activity of muscle groups. It is a non-invasive method used to evaluate muscle activation. Delsys Trigno Wireless System device will be used for measurements. Measurements using silver-silver chloride (Ag-AgCl) disposable adhesive electrodes will be performed in accordance with the criteria of SENIAM (surface EMG for non-invasive assessment of muscle) and literature.
Measured: Change from Baseline at 10 days and at 5 weeks
Pediatric Evaluation of Disability Inventory (PEDI)
PEDI evaluates disability, activity and participation in pediatric population. It consist of 197 items and each item scored in the way 0: can not do, 1: can do.
Measured: Change from Baseline at 10 days and at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Sep 2019
- Primary completion15 Sep 2020
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spastic Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sezen Tezcan, Abant Izzet Baysal University
- Investigators
- Tamer Çankaya, Study director, Abant Izzet Baysal UniversitySezen Tezcan, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064788
- Sponsor's protocol ID
- AIBU-FTR-ST-01
- Status last verified
- Feb 2021
- First submitted
- 20 Aug 2019
- Last updated
- 15 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taub E, Ramey SL, DeLuca S, Echols K. Efficacy of constraint-induced movement therapy for children with cerebral palsy with asymmetric motor impairment. Pediatrics. 2004 Feb;113(2):305-12. doi: 10.1542/peds.113.2.305.
PubMed 14754942Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.
PubMed 19489088Hoare BJ, Wasiak J, Imms C, Carey L. Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004149. doi: 10.1002/14651858.CD004149.pub2.
PubMed 17443542Stearns GE, Burtner P, Keenan KM, Qualls C, Phillips J. Effects of constraint-induced movement therapy on hand skills and muscle recruitment of children with spastic hemiplegic cerebral palsy. NeuroRehabilitation. 2009;24(2):95-108. doi: 10.3233/NRE-2009-0459.
PubMed 19339749
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Modified Constraint-Induced Movement Therapy Administered on Consecutive or Intermittent Days on Upper Extremity Function in Individuals With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04064788
- Acronym / sponsor ID
- AIBU-FTR-ST-01
- Conditions
- Spastic Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 22 Aug 2019 (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.
Cerebral palsy (CP) is defined as a non-progressive lesion of the developing foetal or infant brain and causes variety of motor, sensory and cognitive impairments. Hemiplegic CP is the most common type of CP in term infants, involving one half of the body. In these individuals, muscle tone is reduced, and there is an inability to perform quality upper extremity movements due to increased muscle tone, increased reflexes, weakness in antagonist muscles. Due to spasticity upper extremity is present in shoulder adduction and internal rotation, elbow flexion and pronation, wrist and fingers flexed and thumb in palm position. Spontaneous movements of the upper extremity are decreased and abnormal. These individuals have a reduced upper extremity function ranging from mild incompetence to almost no use of the hand.
Constraint-Induced Movement Therapy (CIMT) is designed to improve the function of the most affected limb by restricting the use of the less affected limb in individuals with unilateral upper extremity involvement and implementing an intensive motor learning-based training program. In pediatric subjects, modified CIMT (mCIMT), which is called a 'child-friendly technique', has been applied, which shows some differences from the form of CIMT in adults. In mCIMT, the restriction time was reduced, activities with the child were performed within a play frame, in the environment in which the child was accustomed, and restriction methods such as gloves, splint, sling were used. In the literature CIMT has been used mainly in children with hemiplegic CP in the pediatric population. However, there are many studies in the literature evaluating the efficacy of mCIMT in individuals with hemiplegic CP and showing beneficial effects on upper extremity speed and skills, and the duration of application restriction varies considerably.
The aim of the investigator's study was to determine the effect of consecutive or intermittent implementation of mCIMT on upper extremity function in children with hemiplegic CP. Thus, it will be determined whether the modification of the duration of administration in the pediatric population varies in treatment results.
Detailed description
33 children with spastic hemiplegia age between 5-18 years will participate study. Children's gross motor skills classified with Gross Motor Classification Sysytem (GMFCS) and hand abilities classified with Manual Ability Classification System (MACS). The children divided into 3 groups, consecutive mCIMT group, intermittent mCIMT group, and traditional physiotherapy control group. The consecutive mCIMT group received mCIMT treatment for 10 consecutive days in addition to the conventional physiotherapy sessions. A sling used to restrict the noninvolved upper extremity. The unaffected upper extremities of the children restricted for 6 hours and activities performed by using shaping techniques under the guidance of same therapist. Within the remaining period, the family implemented the activities with his/her child that are determined by the therapist using the motor learning principles, appropriate to the age of the child and that he / she likes to do. The assessments performed for all three groups before, 10 days after and 5 weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Consecutive mCIMT group | Experimental | Other: Consecutive Modified Constraint-Induced Movement Therapy6 hours / day, 10 consecutive days, 60 hours mKZHT + 2 days 45 minutes / day traditional physiotherapy |
| Intermittent mCIMT group | Experimental | Other: Intermittent Modified Constraint-Induced Movement Therapy6 hours / day 2 days a week 5 weeks, a total of 60 hours mKZHT + 2 days 45 min / day traditional physiotherapy |
| Traditional physiotherapy control group | Active comparator | Other: Traditional physiotherapy45 min / day, 2 days a week traditional physiotherapy |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- confirmed diagnosis of hemiplegic CP
- 5-18 years of age
- MACS level I, II or III
- GMFCS level I
- To have sufficient communication skills
Key exclusion criteria (4 listed)
- Visual and hearing impairment
- Family refuses to participate in the study
- There is a walking and balance problem that may cause a fall risk during the use of a sling
- Behavioral problems at the level to reject the practices to be performed within the study
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 |
|---|---|---|
| Consecutive Modified Constraint-Induced Movement TherapyConsecutive mCIMT group received 6 hours per day mCIMT sessions for consecutive 10 days. Accompanied by a physiotherapist in 1 hour of the 6-hour restriction period, the family was guided within the remaining period and the activities were adapted to daily life. | Other | Consecutive mCIMT group |
| Traditional physiotherapyTraditional physiotherapy within a specific program | Other | Traditional physiotherapy control group |
| Intermittent Modified Constraint-Induced Movement TherapyIntermittent mCIMT group received mCIMT session 6 hours per day for 10 days, spread over 5 weeks (two days per week). Accompanied by a physiotherapist in 1 hour of the 6-hour restriction period, the family was guided within the remaining period and the activities were adapted to daily life. | Other | Intermittent mCIMT group |
Primary outcome
Children's Hand-Use Experience Questionnaire (CHEQ)
Time frame: Change from Baseline at 10 days and at 5 weeks
Assessing children's experience of using the affected hand in activities of daily living where usually two hands are needed. There are 29 items at questionnaire. When respondents answered the questionnaire, they were first asked whether the activity included in the questionnaire was conducted independently. If the activities can be done independently, it is questioned whether one or two hands are used during the activities. If two hands are used, answers and scores to the following 3 sub-questions are sought: hand use, time use in comparison to peers, experience of feeling bothered while doing the activity. A higher score indicates a better level of independence.
Jebsen-Taylor Hand Function Test
Time frame: Change from Baseline at 10 days and at 5 weeks
This is an objective test to evaluate hand function for a person's activities of daily living. Test consist of 7 subtests includes writing, card turning, manipulate small common objects, simulated feeding, stacking checkers, moving large light objects and moving large heavy objects. We will use 6 subtests except writing in our study.
7 secondary outcomes
Gross Motor Classification System (GMFCS)
Time frame: At Baseline
Manual Ability Classification System (MACS)
Time frame: At Baseline
Pediatric Balance Scale (PBS)
Time frame: At Baseline
Modified Tardieu Scale (MTS)
Time frame: Change from Baseline at 10 days and at 5 weeks
ABILHAND-Kids Questionnaire
Time frame: Change from Baseline at 10 days and at 5 weeks
Surface electromyography (sEMG)
Time frame: Change from Baseline at 10 days and at 5 weeks
Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: Change from Baseline at 10 days and at 5 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 15 Feb 2021.
- Background: PubMed 14754942Taub E, Ramey SL, DeLuca S, Echols K. Efficacy of constraint-induced movement therapy for children with cerebral palsy with asymmetric motor impairment. Pediatrics. 2004 Feb;113(2):305-12. doi: 10.1542/peds.113.2.305.
- Background: PubMed 19489088Brady K, Garcia T. Constraint-induced movement therapy (CIMT): pediatric applications. Dev Disabil Res Rev. 2009;15(2):102-11. doi: 10.1002/ddrr.59.
- Background: PubMed 17443542Hoare BJ, Wasiak J, Imms C, Carey L. Constraint-induced movement therapy in the treatment of the upper limb in children with hemiplegic cerebral palsy. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD004149. doi: 10.1002/14651858.CD004149.pub2.
- Background: PubMed 19339749Stearns GE, Burtner P, Keenan KM, Qualls C, Phillips J. Effects of constraint-induced movement therapy on hand skills and muscle recruitment of children with spastic hemiplegic cerebral palsy. NeuroRehabilitation. 2009;24(2):95-108. doi: 10.3233/NRE-2009-0459.
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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.
Tamer Çankaya study director
Abant Izzet Baysal University
Sezen Tezcan principal investigator
Abant Izzet Baysal 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 Consecutive Modified Constraint-Induced Movement Therapy, Traditional physiotherapy and Intermittent Modified Constraint-Induced Movement Therapy in people with Spastic Hemiplegic Cerebral Palsy, run by Abant Izzet Baysal 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 10 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 15 Feb 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?
Children's Hand-Use Experience Questionnaire (CHEQ) (time frame: Change from Baseline at 10 days and at 5 weeks). 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 NCT04064788, which also lists 4 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 15 Feb 2021.