Kinect Sensor in Cerebral Palsy Children: Phase 2.1

September 16, 2022 updated by: Sivaporn Vongpipatana, Mahidol University

The Engineer-built System, Video-game Based Kinect Sensor in Upper Extremities Problems in Cerebral Palsy Children: Phase 2.1

There are 3 phases of the study. This registration is phase 2.1.This registration will conduct a pilot study in the cerebral palsy children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Spastic cerebral palsy aged 10-15 years
  • Sufficient cognitive/attention capacity to understand basic instructions
  • Can cooperate with the therapist for short period of time during training
  • Manual Ability Classification System (MACS) 2-3
  • Zancolli classification of the affected upper extremity was grade I-II.
  • Give the informed consent

Exclusion Criteria:

  • Inability to understand the instruction and follow the task
  • Severe comorbidities, visual or auditory impairment
  • Had history of Botulinum toxin injection on the affected upper extremity for last 6 months or receive the injection during the study time
  • Other treatment options planned on the affected upper extremity during the study time
  • Wear daytime orthosis on the affected limb
  • Zancolli classification of the affected hand was grade III.
  • Got an epilepsy or convulsive condition
  • Denied to give the informed consent or continue the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: video game in CP children (pilot study)
The cerebral palsy children will play the engineer-built system, video-game based Kinect sensor 3 times/week for 5 weeks. Each session will last for 40 minutes. The video-game Kinect sensor was developed by the researcher team.
Device: the engineer-built system, video-game based Kinect sensor
The engineer-built system, video-game based Kinect sensor was developed by the researcher team.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: before starting the intervention and after finishing the intervention within 1 week
The range or motion of shoulder, elbow and wrist will be assessed by goniometer. The assessment will be done before starting the intervention as the baseline and then after finishing the intervention to detect change of range of motion from the the baseline. The range of motion will be reported in degrees.
before starting the intervention and after finishing the intervention within 1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Box and block test
Time Frame: before starting the intervention and after finishing the intervention within 1 week
The name 'box and block test' is an unabbreviated scale title. The minimum score is zero and the maximum score is infinity.
before starting the intervention and after finishing the intervention within 1 week
ABILHANDS-Kids
Time Frame: before starting the intervention and after finishing the intervention within 1 week
The ABILHANDS-kids is the name of the test. It is not an unabbreviated name. The children will be asked the difficulty of doing their activities of daily living by using 21 questionnaires. The rating of difficulties were impossible, difficult and easy. Then the rating would be score as impossible=0, difficult=1 and easy = 2. The analysis of the score of there items will use the Rasch analysis which it is available online on http://rssandbox.iescagilly.be/~abilhand-kids-cerebral-palsy-en.html. The minimum score means a worse outcome and the maximum score means the better outcome.
before starting the intervention and after finishing the intervention within 1 week
EQ-5D-Y
Time Frame: before starting the intervention and after finishing the intervention within 1 week
The EQ-5D-Y is a questionnaire which has 2 parts for a participant to complete. There are 5 questions asking in first part: mobility, looking after myself, doing usual activities, having pain or discomfort and feelin worried, sad or unhappy. The participant needs to rate these questions in 3 rating score: no problem, with some problem or with a lot of problem. The rating score will be coded as no problem=1, with some problem = 1 and with a lot of problem = 2. The code 11111 is the best condition and the code 33333 is the worst condition. The second part of the questionnaire is the EQ-VAS which the participants need to rate their condition on the linear scale from 0-100. The worst condition is score 0 and the best condition is score 100.Then the coding from the first part will be converted as an index value.
before starting the intervention and after finishing the intervention within 1 week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
patient satisfaction form
Time Frame: immediately after finishing the intervention
The patient satisfaction form is about the questionnaire asking about the satisfaction of playing game in these areas: the presentation of games: the contents of game, the convenience and the outcome after playing game. The participants will rate each question in 5-likert scale: totally disagree, disagree, neutral, agree and totally agree.
immediately after finishing the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mahidol University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Warakorn Charoensuk
Apiphan Iamchaimongkol
Tulyapruek Tawonsawatruk

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sivaporn Vongpipatana, Department of Rehabilitation Medicine, Faculty of Medicine Ramathibodi Hospital Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MURA2021/768-2.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

I plan to share the information about the result of the study with the statistician and some team members for the analysis. The sharing will not be linked to the patient identification.

IPD Sharing Time Frame

within 3 months after harvesting the data

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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