Cerebral PalsyNCT04516876
Efficacy Research of Bimanual Intensive Training in Children With Hemiplegic Cerebral Palsy
A study testing Camp-based bimanual intensive training(BIT) in people with Cerebral Palsy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This research project aims to investigate the feasibility, efficacy, and acceptability of camp-based model of BIT. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Camp-based bimanual intensive training(BIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Aug 2020to 3 Aug 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of cerebral palsy(CP) with one or more affected sides.
- Considerable nonuse of the affected upper limb (amount-of-use score of the Pediatric Motor Activity Log < 2.5).
- No excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment.
- No severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner 's clinical observation.
- No injections of botulinum toxin type A or operations on the upper limb within 6 months.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University, Department of Occupational Therapy
Taipei, 100
Tien-Ni Wang, PhD, 886 23366-8163, tnwang@ntu.edu.tw
About this study
This research project aims to investigate the feasibility, efficacy, and acceptability of camp-based model of BIT.
- Conditions
- Cerebral Palsy
- Being tested
- Camp-based bimanual intensive training(BIT)
- Keywords
- cerebral palsy, bimanual intensive training, occupational therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camp-based bimanual intensive training(BIT)Other
The day-camp BIT model will be delivered in a group-based design. In day-camp model, each child is assigned to a trained therapist to maintain at least a 1:1 to 1:2 ratios of therapy and child. The therapist will monitor and modify the activities to fit each individual's ability and need to make sure the intervention quality is equivalence to the individualized treatment method. The chosen tasks of each intervention session have to be considering the child's preference, age-appropriated, and at the right level of difficulty. Target movements are embedded in the functional activities, whereby the environment is manipulated to vary task requirement and the difficulty is graded to match the child's capacity.
| Study group | Role | What they receive |
|---|---|---|
| Camp-based bimanual intensive training(BIT) | Experimental | Not described Receives: Other: Camp-based bimanual intensive training(BIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score changes of Melbourne Assessment 2
The Melbourne Assessment 2(MA2) was developed to investigate the objective upper-limb movement in children with CP aged 2.5 to 15 years.The four main elements of movement quality include (1) amount of active ROM; (2) accuracy; (3) dexterity of finger movements; and (4) fluency or smoothness of movement. The scoring sheet consists of 3-, 4-, or 5-point scales from 0 to 4 that allocate scores on the 14 items.Higher scores mean a better outcome.
Measured: baseline, after one week, after 2 months, after 6 months
Secondary outcomes (11)
Score changes of Bruininks-Oseretsky Test of Motor Proficiency
The subtest 3 of the Bruininks-Oseretsky Test(BOT-2), manual dexterity (MD), will be used to assess a child's upper limb dexterity. The subtests 3 of the BOT-2 consist of 5 goal-directed activities that involve reaching, grasping, and bimanual coordination with small objects to investigate a child's upper limb manual function.Higher scores mean a better outcome.
Measured: baseline, after one week, after 2 months, after 6 months
Score changes of Box and Block test
The Box and Block test (BBT) assesses manual dexterity by county the number of blocks that are transferred with a single hand from one compartment to another within 60 seconds.Higher scores mean a better outcome.
Measured: baseline, after one week, after 2 months, after 6 months
Performance changes of motion analysis
Three-dimensional marker trajectory data will be measured using a motion analysis system (Vicon MX, Oxford Metrics Group, U.K.). Twenty-eight passive infrared retroreflective markers will be attached to the skin of the body segments to track the motion of the body segments. For the performance outcome measures, endpoint variables during reach-to-grasp task, namely reaction time, movement time, movement unit, peak velocity and its time percentage during the movement time will be calculated using the wrist marker. For the performance production measures, joint angles of the shoulder, elbow and wrist during reach-to-grasp task will also be calculated to represent the motor strategy of children with CP before and after intervention.
Measured: baseline, after one week, after 2 months, after 6 months
Score changes of Pediatric Motor Activity Log-Revised
The Pediatric Motor Activity Log-Revised(PMAL-R) is a parent-reported evaluative tool used to capture the spontaneous use of the affected upper limb in 22 daily activities. Each activity is rated by parents/careers on two set (how often and how well) of 6-point ordinal scales (0-5). The 'how often' scale measures amount of use, and the 'how well' scale measures quality of movement, of the affected upper limb.Higher scores mean a better outcome.
Measured: baseline, after one week, after 2 months, after 6 months
Score changes of ABILHAND-kids Questionnaire
The ABILHAND-Kids questionnaire is a Rasch-based assessment that measures children's perceived difficulty in performing ADL that require the use of the bilateral upper limbs. It contains 21 items measuring manual ability and is rated on a 3-point response scale(0-2). The parent is asked to fill in the questionnaire by estimating their child's ease or difficulty in performing each activity, irrespective of the limb(s) the child actually use and whatever the strategies used to perform the activity.Higher scores mean a better outcome .
Measured: baseline, after one week, after 2 months, after 6 months
Score changes of Pediatric Evaluation of Disability Inventory
The Pediatric Evaluation of Disability Inventory(PEDI) is a parent-reported questionnaire. It contains two subscales :(1)functional skill scale (2)caregiver assistance scale. The parent is asked to fill in the questionnaire by estimating their child's performance capability in 197 items in three domains :(1)self-care (2)mobility (3)social is rated on a 2-point response scale(0-1). In caregiver assistance scale, the needs of caregiver assistance to complete each activity are scored from 0 to 5 point.Higher scores mean a better outcome in both parts .
Measured: baseline, after one week, after 2 months, after 6 months
Score changes of Dimensions of Mastery Questionnaire
Measured: baseline, after one week, after 2 months, after 6 months
Score changes of Test of Playfulness
Measured: from the first day to the sixth day of the intervention
Score changes of Pediatric Engagement Questionnaire
Measured: from the first day to the sixth day of the intervention
Score changes of Client Satisfaction Questionnaire
Measured: from the first day to the sixth day of the intervention
Score changes of Parenting Stress Index-Short Form
The Parenting Stress Index-Short Form(PSI-SF) is direct derivative from the Parenting Stress Index (PSI) full-length test which was created to sample a diverse range of potential influences on parenting practices to address the need for a psychometrically sound but brief screening measure of parenting stress. All 36 items of the PSI-SF consist of three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Each subscale consists of 12 items rated from 1 (strongly disagree) to 5 (strongly agree). High scores on the subscale and PSI-SF total score indicate greater level of stress
Measured: baseline, after one week, after 2 months, after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start3 Aug 2020
- Primary completion3 Aug 2024 (estimated)
- Study completion3 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516876
- Sponsor's protocol ID
- 202004060RIND
- Status last verified
- Mar 2024
- First submitted
- 13 Aug 2020
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Research of Bimanual Intensive Training in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04516876
- Acronym / sponsor ID
- 202004060RIND
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, bimanual intensive training, occupational therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 3 Aug 2024 (estimated)
- Study completion
- 3 Aug 2024 (estimated)
- First posted
- 18 Aug 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 research project aims to investigate the feasibility, efficacy, and acceptability of camp-based model of BIT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camp-based bimanual intensive training(BIT) | Experimental | Other: Camp-based bimanual intensive training(BIT) |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of cerebral palsy(CP) with one or more affected sides.
- Considerable nonuse of the affected upper limb (amount-of-use score of the Pediatric Motor Activity Log < 2.5).
- No excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment.
- No severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner 's clinical observation.
- No injections of botulinum toxin type A or operations on the upper limb within 6 months.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Camp-based bimanual intensive training(BIT)The day-camp BIT model will be delivered in a group-based design. In day-camp model, each child is assigned to a trained therapist to maintain at least a 1:1 to 1:2 ratios of therapy and child. The therapist will monitor and modify the activities to fit each individual's ability and need to make sure the intervention quality is equivalence to the individualized treatment method. The chosen tasks of each intervention session have to be considering the child's preference, age-appropriated, and at the right level of difficulty. Target movements are embedded in the functional activities, whereby the environment is manipulated to vary task requirement and the difficulty is graded to match the child's capacity. | Other | Camp-based bimanual intensive training(BIT) |
Primary outcome
Score changes of Melbourne Assessment 2
Time frame: baseline, after one week, after 2 months, after 6 months
The Melbourne Assessment 2(MA2) was developed to investigate the objective upper-limb movement in children with CP aged 2.5 to 15 years.The four main elements of movement quality include (1) amount of active ROM; (2) accuracy; (3) dexterity of finger movements; and (4) fluency or smoothness of movement. The scoring sheet consists of 3-, 4-, or 5-point scales from 0 to 4 that allocate scores on the 14 items.Higher scores mean a better outcome.
11 secondary outcomes
Score changes of Bruininks-Oseretsky Test of Motor Proficiency
Time frame: baseline, after one week, after 2 months, after 6 months
Score changes of Box and Block test
Time frame: baseline, after one week, after 2 months, after 6 months
Performance changes of motion analysis
Time frame: baseline, after one week, after 2 months, after 6 months
Score changes of Pediatric Motor Activity Log-Revised
Time frame: baseline, after one week, after 2 months, after 6 months
Score changes of ABILHAND-kids Questionnaire
Time frame: baseline, after one week, after 2 months, after 6 months
Score changes of Pediatric Evaluation of Disability Inventory
Time frame: baseline, after one week, after 2 months, after 6 months
Score changes of Dimensions of Mastery Questionnaire
Time frame: baseline, after one week, after 2 months, after 6 months
Score changes of Test of Playfulness
Time frame: from the first day to the sixth day of the intervention
Score changes of Pediatric Engagement Questionnaire
Time frame: from the first day to the sixth day of the intervention
Score changes of Client Satisfaction Questionnaire
Time frame: from the first day to the sixth day of the intervention
Score changes of Parenting Stress Index-Short Form
Time frame: baseline, after one week, after 2 months, after 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Camp-based bimanual intensive training(BIT) in people with Cerebral Palsy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 0 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 12 Mar 2024. 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 Taiwan. 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 Tien-Ni Wang, PhD (+886 23366-8163, tnwang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score changes of Melbourne Assessment 2 (time frame: baseline, after one week, after 2 months, after 6 months). 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 12 Mar 2024.