Development of Innovative Modular 3D-Printed Dynamic Orthoses: Application Programs for Hand Function Facilitation in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Box and Block Test
研究概览
简要总结
This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors.
详细描述
This study is a randomized controlled intervention trial. Participants are recruited from two medical centers in Taiwan and undergo a continuous 6-week intervention for post-stroke movement rehabilitation. The control group receives traditional stroke occupational therapy rehabilitation. The experimental group, in addition to traditional treatment, supplements their therapy with the use of modular 3D printed dynamic orthoses developed by the research team for home training. Both groups undergo two effectiveness follow-up assessments, one month and two months after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Onset of stroke at least three months ago;
- •Upper limb Brunnstrom stage II~IV;
- •Shoulder can actively flex at least 45 degrees.
排除标准
- •Affected hand has regained autonomous grasping function, able to grasp and release a tennis ball 10 times within 2 minutes;
- •Joint deformity or stiffness in the affected hand that prevents the use of the dynamic orthosis;
- •Diagnosis of other neurological disorders affecting motor control, such as neglect, Parkinson's disease, etc.;
- •Inability to follow therapist guidance;
- •Currently undergoing other specific treatments affecting motor function recovery (such as rTMS and BTX).
研究组 & 干预措施
Dynamic-orthosis training group
Participants will undergo traditional occupational therapy (2-3 times per week, one hour per session, for a total of six weeks), supplemented with an additional home-based dynamic orthotic therapy program (five days per week, one hour per session, for six weeks). The style of the dynamic orthosis will be selected by the researchers based on the participants' movement performance and rehabilitation goals, and it will be adjusted or replaced as their abilities progress.
干预措施: Dynamic-orthosis (Device)
Dynamic-orthosis training group
Participants will undergo traditional occupational therapy (2-3 times per week, one hour per session, for a total of six weeks), supplemented with an additional home-based dynamic orthotic therapy program (five days per week, one hour per session, for six weeks). The style of the dynamic orthosis will be selected by the researchers based on the participants' movement performance and rehabilitation goals, and it will be adjusted or replaced as their abilities progress.
干预措施: Traditional stroke occupational therapy training (Other)
Regular training group
Participants will receive traditional occupational therapy (2-3 sessions per week, one hour per session, for a total of six weeks). The training program includes muscle strength training, reaching and grasping exercises, manual tone control, motor facilitation, and activities of daily living training. During the study period, participants will not wear any hand dynamic orthosis during training.
干预措施: Traditional stroke occupational therapy training (Other)
结局指标
主要结局
Box and Block Test
时间窗: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
The Box and Block Test (BBT) is a tool used to assess manual dexterity, known for its short assessment time, simplicity, and ease of understanding. It exhibits excellent test-retest reliability (0.96) and inter-rater reliability (0.99). The test involves counting the number of cubes a person can move within one minute, with a higher quantity indicating better functionality. The size of the cubes is 2.5cm³, and there are a total of 150 cubes. Past research suggests a Minimal Clinically Important Difference (MCID) value of 5.5 cubes for the BBT.
Fugl-Meyer Assessment- Upper Extremity
时间窗: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
The Fugl-Meyer Assessment-Upper Extremity (FMA-UE) is a specialized test designed for evaluating motor function in individuals post-stroke. It employs an ordinal scale to score 33 items related to upper limb movements, with a total score of 66 points. Each item reflects movements indicative of motor function in post-stroke hemiparetic patients, covering a range from proximal to distal joints. The FMA-UE has undergone extensive testing and has been found to possess excellent psychometric properties. It is considered an effective assessment tool for upper limb motor function, particularly suitable for chronic stroke patients with moderate to severe impairments.
Motor Activity Log
时间窗: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
The Motor Activity Log (MAL) is a questionnaire-based assessment that evaluates the amount of use (AOU) and quality of movement (QOM) of the affected side in daily activities. The scoring for amount of use ranges from 0 (never using the affected hand in the activity) to 5 (always using the affected hand in the activity). Quality of movement is scored from 0 (unable to use the affected hand) to 5 (movement quality comparable to pre-stroke). There are a total of 28 items in the assessment, recording the average scores for both amount of use and movement quality for each item. Previous research has demonstrated good construct validity for this scale, with a Minimal Clinically Important Difference (MCID) ranging from 1.0 to 1.1 points.
次要结局
- Modified Ashworth scale(Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）)
- Upper limb joint range of motion(Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）)
研究者
Jer-Hao Chang
Associate Professor
National Cheng-Kung University Hospital