Evaluating the Effect of Virtual Reality on the Upper-extremity Function of Children With Hemiplegic Cerebral Palsy Participating in Hand Arm Bimanual Training Camps
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Box and Blocks Score
研究概览
简要总结
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 deficits will receive 40 hours of either HABIT-VR or standard HABIT (4 hours per day, 5days/week, for two consecutive weeks), during which the investigators will track their performance of the tasks and their movements through 3-D motion tracking of the VR system. Post-camp, again the investigators will assess upper-extremity motor function. Additionally the investigators will assess pre to post camp improvement in hand function and bimanual coordination using Assisting Hand Assessment (AHA), Manual Ability Classification System (MACS), and manual dexterity using Box and Block test and 9 Hole Peg test.
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 Virtual Reality Laboratory in the Munroe-Meyer Institute (MMI), with all participants and their families being screened for Corona Virus Disease 2019 (COVID-19) at the entrance of MMI. All study personnel will be wearing the required protective equipment to go over the consent form. All procedures will be reviewed with the parents once again.
There will be two groups for this investigation, each group will participate in a single camp. One group/camp will be 100% HABIT-VR, the other group/camp will participate in a standard HABIT camp with zero VR. Subjects will be assigned to the 2022 camp on a first come first serve basis until the camp is full, the remaining subjects will participate in the 2023 camp.
After the parents sign the informed consent, the investigators will assess the hand function and bimanual coordination using the Box and Block test and 9 hole Peg test, both in the traditional environment and in a virtual environment, as a measure of manual dexterity. Additionally, the investigators will assess the hand function and bimanual coordination using Assisting Hand Assessment (AHA) for children with HCP. Video recordings of the AHA, BBT, and Nine Peg Hole Test sessions will be taken to validate test scores in post. Further, the participants will undergo Range of Motion, Grip Strength, and Functional Reach testing, all tests used in clinic and will be administered by our clinical research team members. The range of motion testing will quantify the degrees the patient can move their upper-extremity joints. The grip strength testing will have the participants squeeze a force measuring handle 3 times with each hand. The Functional Reach Test assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position. The investigators will also collect baseline physiological responses during the pre-assessment. The child will wear an Empatica E4 device that records their skin temperature, their galvanic skin response, and their heart rate. These data will be used to compare to their physiological responses during the camp, to assess arousal levels and acceptability difference between the camps.
After the pre-assessment, the investigators will enroll children for 40 hrs HABIT-VR or standard HABIT, which will be conducted for 4 hrs/day, 5 days/week for two consecutive weeks. Both groups will occur as a summer camp for children with HCP. The children will be assigned in order of enrollment and the camps will be held serially. Two participating personnel per child will continuously monitor the child's activities. The parent will be required to stay at the research site each day during the 40 hrs camp session. The HABIT-VR camp will consists of various bimanual goal directed activities and functional training in a play context in VR, 4 hrs/day for 10 days. The children will play HABIT-VR games in 40 minute blocks with mandatory breaks every 30 minutes. The length of these breaks will be child driven, but will be at least 10 minutes, as suggested by the US Department of Business, Energy and Industrial Strategy. Additionally, the children will be taken to an indoor or outdoor playground for 30 minutes halfway through each day, to give them further extended breaks.In the standard HABIT camp, children will participate in self-selected activities that require both hands to succeed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standard HABIT (Behavioral)
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.
干预措施: HABIT-VR (Behavioral)
结局指标
主要结局
Box and Blocks Score
时间窗: Approximately 1 week after the camp
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.
Assisting Hand Assessment Score
时间窗: Approximately 1 week after the camp
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.
9-Hole Peg Test Score
时间窗: Approximately 1 week after the camp
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.
Assisting Hand Assessment Score
时间窗: Approximately 1 week before the camp
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.
Box and Blocks Score
时间窗: Approximately 1 week before the camp
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.
9-Hole Peg Test Score
时间窗: Approximately 1 week before the camp
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.
次要结局
- Heart Rate(Approximately 1 week after the camp for 5 minutes)
- Galvanic Skin Response(Approximately 1 week after the camp for 5 minutes)
- Skin Temperature(Approximately 1 week after the camp for 5 minutes)
- Heart Rate(Approximately 1 week before the camp for 5 minutes)
- Heart Rate(During the camp up to 40 hours)
- Galvanic Skin Response(Approximately 1 week before the camp for 5 minutes)
- Galvanic Skin Response(During the camp up to 40 hours)
- Skin Temperature(Approximately 1 week before the camp for 5 minutes)
- Skin Temperature(During the camp up to 40 hours)
