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Hand-Arm Bimanual Intensive Therapy in Virtual Reality Versus Standard Hand-Arm Bimanual Intensive Therapy (HABIT-VR) 17 虚拟

进行中(不再招募)
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临床试验NCT05867368 (HABIT-VR)是一项针对半身不遂型脑瘫干预性研究试验,目前试验状态为进行中(不再招募)。试验始于2022年7月18日,计划招募17名患者。该研究由内布拉斯加大学主导,预计于2026年9月21日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2025年9月22日
简要概括
The goal of this intervention study is- 1. To determine if a camp that solely uses VR software based on HABIT (HABIT-VR) still improves the motor planning and execution deficits in children with hemiplegic cerebral palsy (HCP) and 2. To determine if HABIT-VR improves bimanual coordination and affected hand function in children with HCP at least as well as a standard HABIT.

Children with motor planning and execution ...

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详细描述
The Physical or Occupational Therapist will first confirm the diagnosis of HCP and refer the child to PI after knowing parental willingness to participate in this investigation. The PI will screen the child for inclusion criteria, explain the purpose of study and procedures to the parents and obtain parental consent for their child's participation in the study.

The process of informed consent will take place in the ...

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官方标题

Evaluating the Effect of Virtual Reality on the Upper-extremity Function of Children With Hemiplegic Cerebral Palsy Participating in Hand Arm Bimanual Training Camps

疾病
半身不遂型脑瘫
出版物
关于此临床试验发表的科学文章和研究论文:
其他研究标识符
  • HABIT-VR
  • 0154-22-EP
NCT编号
实际开始日期
2022-07-18
最近更新发布
2025-09-22
预计完成日期
2026-09-21
计划入组人数
17
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中(不再招募)
关键词
Hand Arm Bimanual Intensive Therapy
Virtual Reality
主要目的
治疗方法
分配方式
非随机
干预模型
平行
盲法
无(开放性试验)
试验组/干预措施
参与者组/试验组干预措施/治疗方法
阳性对照Standard HABIT
Children will receive hand arm bimanual intensive therapy the way it is typically delivered. Children will receive 40 hrs of one-on-one bimanual therapy, delivered as play. Activities will be self-selected, but all options will require both hands to succeed.
Standard HABIT
HABIT is a camp where children play self-select activities that require both hands to succeed.
实验性HABIT-VR
Children will receive hand arm bimanual intensive therapy, however, it will be through the use of custom virtual reality games. Children will receive 40 hrs of one-on-one bimanual therapy, delivered through the virtual reality games. Activities will be self-selected, but all games have a task constraint, requiring both hands to succeed.
HABIT-VR
HABIT-VR is a suite of video games designed on the principals of HABIT treatments. The games are delivered in virtual reality, because these systems provide a way to track the movements of both hands and build software that requires both hands to succeed.
主要终点
结果指标度量标准描述时间框架
Assisting Hand Assessment Score
The Assisting Hand Assessment (AHA)measure and describe how effectively individuals with a hand/arm impairment use their two hands together to perform bimanual tasks. The scale range from 22 points, meaning that the hand is not used at all, to 88 points meaning that the hand is used effectively, like a normal non-dominant hand. The score reflects the child's ability to use the affected hand in bimanual performance. Higher scores are better.
Approximately 1 week before the camp
Assisting Hand Assessment Score
The Assisting Hand Assessment (AHA)measure and describe how effectively individuals with a hand/arm impairment use their two hands together to perform bimanual tasks. The scale range from 22 points, meaning that the hand is not used at all, to 88 points meaning that the hand is used effectively, like a normal non-dominant hand. The score reflects the child's ability to use the affected hand in bimanual performance. Higher scores ar better.
Approximately 1 week after the camp
Box and Blocks Score
The Box and Block Test (BBT) measures unilateral gross manual dexterity. Children move blocks from one box to another in a minute. The minimum score is zero and there is no maximum score, as the blocks get reset if the child runs out. Higher scores are better.
Approximately 1 week before the camp
Box and Blocks Score
The Box and Block Test (BBT) measures unilateral gross manual dexterity. Children move blocks from one box to another in a minute. The minimum score is zero and there is no maximum score, as the blocks get reset if the child runs out. Higher scores are better.
Approximately 1 week after the camp
9-Hole Peg Test Score
The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity. Children pick up pegs and try to place them in holes on a game board. The minimum score is zero and there is no maximum score, as it is a rate per second of how fast the child places the pegs. Lower scores are better.
Approximately 1 week before the camp
9-Hole Peg Test Score
The Nine-Hole Peg Test (9-HPT) is a standardized, quantitative assessment used to measure finger dexterity. Children pick up pegs and try to place them in holes on a game board. The minimum score is zero and there is no maximum score, as it is a rate per second of how fast the child places the pegs. Lower scores are better.
Approximately 1 week after the camp
次要终点
结果指标度量标准描述时间框架
Heart Rate
The investigators are collecting heart rate using an Empatica E4 during the camps. Heart rate is the number of heartbeats per minute. The typical heart rate for the age range included in this study is as follows: Children 6 years old: 75 to 115 beats per minute Children 7 to 9 years old: 70 to 110 beats per minute Children 10 years and older: 60 to 100 beats per minute The sensor measuring heart rate will use infrared light to measure the speed of blood as it moves through the arteries. This is non-invasive.
Approximately 1 week before the camp for 5 minutes
Heart Rate
The investigators are collecting heart rate using an Empatica E4 during the camps. Heart rate is the number of heartbeats per minute. The typical heart rate for the age range included in this study is as follows: Children 6 years old: 75 to 115 beats per minute Children 7 to 9 years old: 70 to 110 beats per minute Children 10 years and older: 60 to 100 beats per minute The sensor measuring heart rate will use infrared light to measure the speed of blood as it moves through the arteries. This is non-invasive.
During the camp up to 40 hours
Heart Rate
The investigators are collecting heart rate using an Empatica E4 during the camps. Heart rate is the number of heartbeats per minute. The typical heart rate for the age range included in this study is as follows: Children 6 years old: 75 to 115 beats per minute Children 7 to 9 years old: 70 to 110 beats per minute Children 10 years and older: 60 to 100 beats per minute The sensor measuring heart rate will use infrared light to measure the speed of blood as it moves through the arteries. This is non-invasive.
Approximately 1 week after the camp for 5 minutes
Galvanic Skin Response
The investigators are collecting galvanic skin responses using an Empatica E4 during the camps. Two electrodes on the watch will press against the skin on the wrist. A low level, and imperceivable signal will be sent between these electrodes to measure the conductivity of the skin. Galvanic Skin Response (GSR) is a physiological measure that has been used in research for over a century. GSR measures the electrical conductance of the skin, which changes in response to emotional arousal and other psychological processes. This non-invasive method has proven to be a useful tool in understanding the mechanisms behind emotional responses and assessing psychological states.
Approximately 1 week before the camp for 5 minutes
Galvanic Skin Response
The investigators are collecting galvanic skin responses using an Empatica E4 during the camps. Two electrodes on the watch will press against the skin on the wrist. A low level, and imperceivable signal will be sent between these electrodes to measure the conductivity of the skin. Galvanic Skin Response (GSR) is a physiological measure that has been used in research for over a century. GSR measures the electrical conductance of the skin, which changes in response to emotional arousal and other psychological processes. This non-invasive method has proven to be a useful tool in understanding the mechanisms behind emotional responses and assessing psychological states.
During the camp up to 40 hours
Galvanic Skin Response
The investigators are collecting galvanic skin responses using an Empatica E4 during the camps. Two electrodes on the watch will press against the skin on the wrist. A low level, and imperceivable signal will be sent between these electrodes to measure the conductivity of the skin. Galvanic Skin Response (GSR) is a physiological measure that has been used in research for over a century. GSR measures the electrical conductance of the skin, which changes in response to emotional arousal and other psychological processes. This non-invasive method has proven to be a useful tool in understanding the mechanisms behind emotional responses and assessing psychological states.
Approximately 1 week after the camp for 5 minutes
Skin Temperature
The investigators are collecting skin temperature using an Empatica E4 during the camps. This will be measured using a sensor that utilizes infrared light. The normal level for adults is between 92.3 and 98.4 Fahrenheit or 33-37 Celsius for peripheral skin temperature. This gives a measure of vasodilation, which can be used to measure stress or excitement.
Approximately 1 week before the camp for 5 minutes
Skin Temperature
The investigators are collecting skin temperature using an Empatica E4 during the camps. This will be measured using a sensor that utilizes infrared light. The normal level for adults is between 92.3 and 98.4 Fahrenheit or 33-37 Celsius for peripheral skin temperature. This gives a measure of vasodilation, which can be used to measure stress or excitement.
During the camp up to 40 hours
Skin Temperature
The investigators are collecting skin temperature using an Empatica E4 during the camps. This will be measured using a sensor that utilizes infrared light. The normal level for adults is between 92.3 and 98.4 Fahrenheit or 33-37 Celsius for peripheral skin temperature. This gives a measure of vasodilation, which can be used to measure stress or excitement.
Approximately 1 week after the camp for 5 minutes
参与助手
资格标准

适龄参与研究
儿童
最低年龄要求
6 Years
适龄性别
全部
  • Children diagnosed as HCP.
  • Children with HCP having Manual Ability Classification System Score (MACS) between I-IV.
  • Parents able to give consent for the assessment and willing to adhere to the assessment and HABIT protocol.

  • Children with any other neurological conditions such as diplegic or tetraplegic cerebral palsy CP, birth injuries such as erbs palsy, brachial plexus lesion or peripheral nerve injuries, spina bifida at the upper thoracic level, leading to inability to move the upper extremity.
  • Children with known visual impairments such as blindness.
  • Children with any obvious musculoskeletal deformity, which will affect the ability to handle objects.
  • Children with musculoskeletal problems such as torticollis, which will affect visual gaze and visual tracking of an object.
没有联系数据。
1 位于 1 个国家/地区的研究中心

Nebraska

University of Nebraska Medical Center, Munroe-Meyer Institute, Omaha, Nebraska, 68106, United States