Cerebral PalsyNCT02949817
The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury
A study testing digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids) and Conventional OT group in people with Cerebral Palsy and Children With Brain Injury, run by Yonsei University at 1 site in South Korea.
Trial summary
This study was designed to establish the clinical evidence for effect of video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea, on upper limb function of children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy, Children With Brain Injury
- What is being tested?
- digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids) and Conventional OT group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2017to 1 Feb 2018
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- MACS (Manual ability classification system) level I, II, III, IV
- Patients without cognitive impairment who are able to comply with protocol-required procedure
- male or female, 4 to 18 years
Who cannot join
- Patients with cognitive impairment who are unable to comply with protocol-required procedure
- Patients with significant visual impairment
- Patients with presence or history of musculoskeletal anomaly who are unable to apply device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury: Single Blind Randomized Controlled Study
This study was designed to establish the clinical evidence for effect of video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea, on upper limb function of children with cerebral palsy. First, the investigators would compare the effect of video-game based rehabilitation therapy to conventional occupational therapy.
Read the detailed description
- Purpose: to elucidate the effect of video-game based rehabilitation therapy system on upper limb function of children with cerebral palsy compared to conventional occupational therapy
- Subjects: total 30 children with cerebral palsy whose upper limb functions are impaired (all 30 children will receive the conventional occupational therapy, but 15 of these children will receive the additional video-game based rehabilitation therapy)
- Intervention: 4 weeks of therapy (6 days per week)
- Studies: functional MRI, computerized motion analysis, upper limb functional assessment (MUUL, ULPRS), ADL evaluation, cognitive evaluation
- Evaluation plan: 1) pre-intervention, 2) post-4 weeks of intervention, 3) 8 weeks after end of intervention
- Conditions
- Cerebral Palsy, Children With Brain Injury
- Being tested
- digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids), Conventional OT group
- Keywords
- upper limb function, multi-IMU (inertial measurement unit) sensors, Melbourne Assessment of Unilateral Upper Limb Function (MUUL-2)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids)Device
1.The Rapael kids, a video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea will be used on upper limb function of children with pediatric brain injury patients. 20 of All 40 children will receive the conventional occupational therapy and additional video-game based rehabilitation therapy, 30 minutes daily 5 times per week, for 4 weeks.
Conventional OT groupOther
- Conventional OT group will recieve the conventional occupational therapy and one more conventional occupational therapy additionally. The additional occupational therapy training will be performed 30 minutes daily 5 times per week, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IMU sensor training group(intervention group) | Experimental | video-game based rehabilitation therapy system training group Receives: Device: digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids) |
| Conventional OT group (control group) | Active comparator | conventional training group (control group) Receives: Other: Conventional OT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of Melbourne Assessment of Unilateral Upper Limb Function
MUUL is the test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions. It comprises 14 test items of reaching to, grasping, releasing and manipulating simple objects. Scoring is completed for the 30 item scores using a three, four or five point scale and the individually defined scoring criteria. The test will be done by occupational therapist. The total score of MUUL will be used for analysis.
Measured: 8 weeks
Secondary outcomes (3)
Total score of upper limb physician's rating scale (ULPRS)
ULPRS assess changes in the movement pattern, focusing on all 3 levels of the arm (palm, forearm, and elbow) to determine whether there is an isolated functional impairment, such as thumb in palm, restricted forearm supination, or a total flexion pattern with thumb in palm, wrist in flexion, forearm supinated, and elbow flexed. The score sheet includes 9 items, and 3-, 4-, and 5-point scales are used to score each component of movement tested. The total score of ULPRS will be used for analysis.
Measured: 8 week
Scaled scores of Pediatric Evaluation of Disability Inventory (PEDI-selfcare)
PEDI is a descriptive measure of a child's current functional performance. It measures both capability and performance of functional activities in three content domains: Self-care, Mobility, Social function. PEDI-selfcare section will be administered by occupational therapist. The Scaled scores of PEDI-selfcare will be used for analysis.
Measured: 8 week
Kinematic data of computerized 3D motion analysis
3D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup. Kinematic data of forearm pronation or supination, wrist flexion or extension, ulnar deviation or radial deviation will be used for analysis.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start24 Jul 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
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 Yonsei 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949817
- Sponsor's protocol ID
- 1-2015-0097
- Status last verified
- Jul 2018
- First submitted
- 14 Mar 2016
- Last updated
- 19 Jul 2018
- 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 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Digital Rehabilitation System With Wearable Multi-IMU (Inertial Measurement Unit) Sensors on Upper Limb Functions in Children With Brain Injury: Single Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02949817
- Acronym / sponsor ID
- 1-2015-0097
- Conditions
- Cerebral Palsy, Children With Brain Injury
- Keywords
- upper limb function, multi-IMU (inertial measurement unit) sensors, Melbourne Assessment of Unilateral Upper Limb Function (MUUL-2)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 31 Oct 2016 (estimated)
- 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 was designed to establish the clinical evidence for effect of video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea, on upper limb function of children with cerebral palsy. First, the investigators would compare the effect of video-game based rehabilitation therapy to conventional occupational therapy.
Detailed description
- Purpose: to elucidate the effect of video-game based rehabilitation therapy system on upper limb function of children with cerebral palsy compared to conventional occupational therapy
- Subjects: total 30 children with cerebral palsy whose upper limb functions are impaired (all 30 children will receive the conventional occupational therapy, but 15 of these children will receive the additional video-game based rehabilitation therapy)
- Intervention: 4 weeks of therapy (6 days per week)
- Studies: functional MRI, computerized motion analysis, upper limb functional assessment (MUUL, ULPRS), ADL evaluation, cognitive evaluation
- Evaluation plan: 1) pre-intervention, 2) post-4 weeks of intervention, 3) 8 weeks after end of intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMU sensor training group(intervention group) | Experimental | Device: digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids)video-game based rehabilitation therapy system training group |
| Conventional OT group (control group) | Active comparator | Other: Conventional OT groupconventional training group (control group) |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- MACS (Manual ability classification system) level I, II, III, IV
- Patients without cognitive impairment who are able to comply with protocol-required procedure
- male or female, 4 to 18 years
Key exclusion criteria (3 listed)
- Patients with cognitive impairment who are unable to comply with protocol-required procedure
- Patients with significant visual impairment
- Patients with presence or history of musculoskeletal anomaly who are unable to apply device
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 |
|---|---|---|
| digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids)1.The Rapael kids, a video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea will be used on upper limb function of children with pediatric brain injury patients. 20 of All 40 children will receive the conventional occupational therapy and additional video-game based rehabilitation therapy, 30 minutes daily 5 times per week, for 4 weeks. | Device | IMU sensor training group(intervention group) |
| Conventional OT group2. Conventional OT group will recieve the conventional occupational therapy and one more conventional occupational therapy additionally. The additional occupational therapy training will be performed 30 minutes daily 5 times per week, for 4 weeks. | Other | Conventional OT group (control group) |
Primary outcome
Total score of Melbourne Assessment of Unilateral Upper Limb Function
Time frame: 8 weeks
MUUL is the test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions. It comprises 14 test items of reaching to, grasping, releasing and manipulating simple objects. Scoring is completed for the 30 item scores using a three, four or five point scale and the individually defined scoring criteria. The test will be done by occupational therapist. The total score of MUUL will be used for analysis.
3 secondary outcomes
Total score of upper limb physician's rating scale (ULPRS)
Time frame: 8 week
Scaled scores of Pediatric Evaluation of Disability Inventory (PEDI-selfcare)
Time frame: 8 week
Kinematic data of computerized 3D motion analysis
Time frame: 8 week
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 19 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids) and Conventional OT group in people with Cerebral Palsy and Children With Brain Injury, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 3 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 19 Jul 2018. 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 South Korea. 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?
Total score of Melbourne Assessment of Unilateral Upper Limb Function (time frame: 8 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 19 Jul 2018.