跳至主要内容
临床试验/NCT06691880
NCT06691880已完成不适用

Translating SMARTS 2: the Integration of Video Gaming Technology Into Traditional Rehabilitation

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2020年3月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Feasibility: Adherence to the protocol as assessed by session attendance

研究概览

简要总结

The investigators are investigating ways to incorporate new technologies that can enhance functional outcome after neurological insult into the patient recovery space. In order to accelerate the translation of these technologies to patient care spaces, the investigators need to identify the locations that are feasible for its use. Currently the investigators are using video game technologies that are used to maximize motor recovery of impaired upper extremities after neurological insult in the outpatient (clinic) setting. These technologies interface with robotics and other hardware to create a therapy experience that is fun, engaging, dynamic, challenging, and promotes repetitions that are otherwise difficult to achieve during conventional post-stroke rehabilitation. The investigators think early use of these technologies could enhance recovery of the arm, but It is not known if use of these technologies in the early post-stroke recovery period is safe and feasible.

详细描述

This study explores a protocolized approach to high-dosed, video-game-based arm training in addition to standard of care rehabilitation in the acute/sub-acute phase of stroke recovery. Patients admitted to the Johns Hopkins Hospital rehabilitation unit or the Brain Rescue Unit with new unilateral upper limb weakness as a result of the patient's sequela will be considered for enrollment. Once consented, participants will be seen 4-5 days per week for up to 60 minutes of additional arm training using gaming technology. Participant response to training will be measured before and after the intervention and function and impairment level will be measured pre and post the training protocol. Participants will be expected to participate in the training protocol for the duration of the hospital stay.

The study involves patients who were already hospitalized at a large teaching institution in Maryland. Participants were screened for eligibility on admission to the hospital. If eligible, the patient was screened in person to determine if he/she was able to follow a 1 step functional command and for willingness to participate. Once agreeable, patients and/or the patient's surrogate decision makers were consented to enroll into the study. Patients were included if a stroke was confirmed by CT or MRI with subsequent unilateral upper extremity weakness (as defined as change in functional use of extremity from baseline or difference in Manual Muscle Testing (MMT) score from unaffected side to affected side). Patients were excluded if unable to sit upright for at least 5 minutes in a chair without arm support, unable to follow 1 step functional commands or had a vision impairment that impeded seeing the television screen. Patients were also excluded if the patient had medical instability as defined by the care provider, orthopedic range of motion precautions including, but not limited to: no active range of motion or weight bearing of the target extremity, heart conditions that limits participation in exercise, active seizures or epilepsy or the inability to communicate pain status.

Once consented, baseline assessments are administered and include the FM-UE and dynamometry. The patients are stratified to a gaming technology based on the baseline FM-UE score. Patients with a FM-UE less than 25 are placed in the Bimanual Arm Training group. During the treatment session, the patients are monitored for tolerance of the session using pre and post vitals including Blood Pressure, Heart Rate, and pulse oximetry. Pre/post pain and fatigue ratings are also maintained using a 10 point-likert scale. Trained clinicians gathered session start and end time. Technological difficulties and other interruptions are documented. Adverse events are gathered and include any swelling or bruising, cut/scratch/irritations, and new numbness or tingling. Intervention clinicians use a detailed stopping criteria to monitor the patient for tolerance and participation in the target time on task. The subjects receive intervention daily outside of the subject's regularly scheduled therapy for the 4-5 days a week (pending clinician availability) for the length of the hospital stay.

On the day of or day prior to discharge, FM-UE and dynamometry is gathered again. Qualitative post-intervention outcome measures are gathered for and included a survey of the patient's experience using a Likert-Scale based questionnaire, a Technology Acceptance Model survey (examines the patient's experience using technology and breaks it down into previously defined domains: Perceived Ease of Use (PEU), Perceived Usefulness (PU), Attitude Toward Using (ATU), Behavioral Intention to Use (BIU), and the Intrinsic Motivation Inventory (IMI).

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
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to Meyer 7 inpatient rehabilitation unit (CIIRP) or Zayed 12 West (12W) Brain Rescue Unit (BRU)
  • Unilateral upper extremity weakness (as defined as change in functional use of extremity from baseline or difference in MMT score from unaffected side to affected side)

排除标准

  • Unable to sit upright for at least 3 minutes
  • Unable to follow 1 step commands
  • Vision impairment that impedes seeing the television screen
  • Medical instability as defined by the care provider
  • Orthopedic range of motion precautions including, but not limited to: no active range of motion or weight bearing of the target extremity
  • Heart condition that limits participation in exercise
  • Active seizures or epilepsy
  • Inability to communicate pain status

研究组 & 干预措施

Video Gaming Technology (VGT) based arm training

Experimental

Patients who meet inclusion criteria will be assessed for level of arm impairment and allocated to either MindPod VGT or Bimanual Arm Trainer VGT based on the severity of impairment. Patients will complete up to 60 minutes of VGT treatment in addition to the standard of care therapy (Physical, occupational, and or speech therapy). Patients will be monitored before, during, and after the sessions for tolerance and response to the treatment. This will include physiological response using measures such as blood pressure, heart rate, and pulse oximeter. Self reported pain and fatigue will be collected using visual analog scales. Safety issues that are predefined as line dislodgement, falls, change in vital signs or pain necessitating interruption of the therapy session will be measured and calculated as the number of adverse events as a proportion of the number of sessions attended

干预措施: MindPod Dolphin VGT (Behavioral)

Video Gaming Technology (VGT) based arm training

Experimental

Patients who meet inclusion criteria will be assessed for level of arm impairment and allocated to either MindPod VGT or Bimanual Arm Trainer VGT based on the severity of impairment. Patients will complete up to 60 minutes of VGT treatment in addition to the standard of care therapy (Physical, occupational, and or speech therapy). Patients will be monitored before, during, and after the sessions for tolerance and response to the treatment. This will include physiological response using measures such as blood pressure, heart rate, and pulse oximeter. Self reported pain and fatigue will be collected using visual analog scales. Safety issues that are predefined as line dislodgement, falls, change in vital signs or pain necessitating interruption of the therapy session will be measured and calculated as the number of adverse events as a proportion of the number of sessions attended

干预措施: Bimanual Arm Trainer VGT (Behavioral)

结局指标

主要结局

Feasibility: Adherence to the protocol as assessed by session attendance

时间窗: Immediately Post Intervention

Adherence to the protocol will be calculated by determining the number of sessions attended as a proportion of the number of possible sessions.

Feasibility: Efficiency (total time on task)

时间窗: Immediately Post Intervention

Efficiency will be calculated by examining the amount of practice (Total time on task) as a proportion of total minutes (Total protocol target duration).

Feasibility: Acceptability of the intervention as assessed by the Technology Acceptance Measure

时间窗: Post intervention up to 2 weeks

Technology Acceptance Measure; scale range is 1-7 (Strongly disagree to Strongly agree) and higher scores indicate better acceptability.

Feasibility: Acceptability of the intervention as assessed by the Intrinsic Motivation Inventory

时间窗: Post Intervention up to 2 weeks

Acceptability of the intervention will be gathered using the Intrinsic Motivation Inventory. This is a 19-item inventory using a 1-7 scale (not at all true to very true) with 3 sub scales: Interest/Enjoyment, Value/Usefulness, Effort/Importance. Higher scores indicate high acceptability.

Heart rate

时间窗: Baseline, Immediately Post-Intervention

Heart rate; mean number of beats per minute.

Blood pressure (mmHg)

时间窗: Baseline, Immediately Post-Intervention

Systolic and diastolic blood pressure.

Pain as assessed by Wong-Baker Faces Pain Rating Scale

时间窗: Baseline, Immediately Post-Intervention

Pain score; (0-10) 10 indicates high level of pain

Fatigue as assessed by Fatigue Visual Analog Scale

时间窗: Baseline, Immediately Post-Intervention

Fatigue score; 0-10 with 10 being greater levels of fatigue

Safety as assessed by the number of adverse events

时间窗: Baseline, Immediately Post-Intervention

Safety as assessed by the number of adverse events.

次要结局

  • Efficacy: Fugl Meyer Upper Extremity(Baseline, Immediately Post-Intervention)
  • Efficacy: Gross Grasp (Dynamometry)(Baseline, Immediately Post-Intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验