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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Tien-Ni Wang, PhD contact

+886 23366-8163

tnwang@ntu.edu.tw

Taiwan1 site, 1 recruiting
  • National Taiwan University, Department of Occupational Therapy

    Taipei, 100

    Tien-Ni Wang, PhD, 886 23366-8163, tnwang@ntu.edu.tw

    Recruiting

Other trials in Taiwan

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 groups in NCT04516876
Study groupRoleWhat they receive
Camp-based bimanual intensive training(BIT)ExperimentalNot 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Score changes of Dimensions of Mastery Questionnaire

    Measured: baseline, after one week, after 2 months, after 6 months

  8. Score changes of Test of Playfulness

    Measured: from the first day to the sixth day of the intervention

  9. Score changes of Pediatric Engagement Questionnaire

    Measured: from the first day to the sixth day of the intervention

  10. Score changes of Client Satisfaction Questionnaire

    Measured: from the first day to the sixth day of the intervention

  11. 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.

  1. First posted18 Aug 2020
  2. Study start3 Aug 2020
  3. Primary completion3 Aug 2024 (estimated)
  4. Study completion3 Aug 2024 (estimated)

Resources

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)
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

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.

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