Technology-supported Motor Rehabilitation for People With Rett Syndrome (TeMoRett) Sub-project: Psychophysiological Personalization of the Technology-supported Motor Rehabilitation for People With Rett Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Counts and timing of obligatory stereotypies
研究概览
简要总结
This study focuses on improving purposeful arm use while simultaneously reducing engagement in stereotypies. It is typically expected that the training period for this study will last about 6 months. The first half of the training periods will be devoted to learning to separate hands to stop the stereotypies that interfere with arm and hand use. In this first half, participants will also need to learn to keep arms apart in order to be actively involved in the chosen game. The second half of the training period will be devoted to learning to stop stereotypies and reach for targets that are intended to start game play. When not touching the targets, the software will interpret that the game should stop and wait for the next target to be touched.
详细描述
Baseline measurements taken at start of study. Training occurs for separation tasks for the first 13 weeks, with four 15-min sessions running per week. To gradually improve in ability to control gaming with arms/hands, each participant has the option of trying 13 levels or challenges on the extent of separation (how far apart hands can be taken.) Training occurs for the final 13 weeks for reaching tasks. Here, the participant must separate hands and reach for a defined target in order to initiate game play. These sessions will also last 15 minutes each and four sessions will be required per week.
At the conclusion of the 26 weeks of training, the measurements of functional arm/hand use, and other behavioral measurements taken at Baseline will be repeated and compared to Baseline to assist in determining the success of the gaming used to train purposeful and functional arm use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •dx of Rett syndrome
- •functional range of motion of both arms
- •no seizures or seizures managed with medication
- •understanding cause and effect
- •midline stereotypies
排除标准
- •no competing orthopedic or neuromuscular diagnosis that impacts shoulder movements
研究组 & 干预措施
Gaming system
The study will involve several sequential phases: pre-intervention testing, cause-and-effect training/intervention, and a post-intervention testing phase. The aim is to learn to control stereotypies and learn to interact with their environment to increase independent play skills. Training will take place using telemedicine methods. The game consists of computer generated games developed by the researchers specifically for the needs of individuals with dyspraxia. The images or video that the participant will watch will be projected to the table. The participant's hand movements to stop their stereotypies will be detected as the Start signal for the game to begin. When hands return to their stereotypy, the computer camera will detect that as the Stop signal and the game will pause until hands are detected separated from each other again.
干预措施: computer gaming (Behavioral)
结局指标
主要结局
Counts and timing of obligatory stereotypies
时间窗: 60 min functional assessment periods: one just before start of intervention (baseline) and one at the end of intervention (post-intervention testing) Weekly data collection from intervention sessions: enrollment to end of intervention 26 weeks later.
We will collect two variables: the number of times the participant engages in her unique stereotypy and the length of time (in seconds) that the stereotypy occurs. Data will be collected from both weekly intervention sessions and the two functional assessments. Functional data will be collected from the movements made by the individual as well as from BEFORE and AFTER questionnaires to be completed by the caregivers of the participant.
Timing and number of separations (ceasing stereotypies)
时间窗: Two 60 minute assessment periods: one just before start of intervention (baseline) and one at the end of intervention (post-intervention testing). Data from intervention sessions will run from enrollment to end of intervention 26 weeks later.
Data will be collected from intervention sessions and the two functional assessments. Data will be in both the number of times each girls separates hands (counts) and timing (in seconds) to record how long hands remained apart. Functional data will be collected from the movements made by the individual as well as from BEFORE and AFTER questionnaires to be completed by the caregivers of the participant.
Reaching data for number of reaches and amount of time reaching occurs
时间窗: Two 60-minute assessment periods: one at baseline and one post final intervention session. Data from weekly intervention will be gathered from enrollment to 26 weeks later when intervention is complete.
Data will be collected from intervention sessions and the two functional reach assessments. Counts of the number of purposeful reaches and the extent of time (measured in seconds) the reach is maintained. Functional data will be collected from the movements made by the individual as well as from BEFORE and AFTER questionnaires to be completed by the caregivers of the participant.
次要结局
未报告次要终点
研究者
Pamela Diener
Co-Principal Investigator
Georgetown University