'Smart Reminder': a Feasibility Pilot Study on the Effects of a Wearable Device Treatment on the Hemiplegic Upper Limb in Persons With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change from baseline Motor Activity Log (MAL)
研究概览
简要总结
This pilot study examines the feasibility and potential effects on upper limb (UL) motor function using a wearable device integrated with a telerehabilitation function in the home setting with chronic stroke survivors.
The study seeks to address the question:
- Is wearable device intervention more effective in promoting arm recovery in stroke survivors than conventional therapy for home-based training? We hypothesize that using a multimodal feedback system in the wearable device can provide more effective training to improve the hemiplegic UL function of chronic stroke survivors than conventional therapy.
This is a single-blinded randomized crossover pilot trial. Twelve participants will be randomly assigned into two groups: the experimental (wristwatch) and the control (conventional therapy) groups. Participants in the experimental group will undergo a 4-week wearable device treatment followed by a 4-week conventional training.
Participants in the control group will complete conventional therapy and then wearable device treatment. There will be a 3-week washout period between treatments. Upper limb motor outcome measures will be evaluated at the following intervals: baseline, post-treatment at 4-week, after a 3-week washout period for pre-intervention, and post-intervention after crossover by research assistants blinded to group allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomization was stratified based on the participant's baseline upper limb severity according to the FTHUE-HK. Masking to treatment allocation for therapist and participants was not feasible.
Only the outcome assessor was blinded to the treatment allocation and participants were instructed not to tell the assessor their group allocation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •unilateral hemispherical involvement
- •diagnosis of stroke with onset ≥ three months
- •hemiplegic upper limb with Functional test for hemiplegic upper extremity-Hong Kong version (FTHUE-HK) ≥ score of 3 (maximum of 7) (Fong et al., 2004).
- •no complaint of excessive pain and swelling over the hemiplegic arm
- •able to provide informed consent to participate.
排除标准
- •participating in another similar form of experimental study during the same period
- •having a history of botulinum toxin injection in the past three months
- •having other significant upper limb impairment, i.e. fixed contractures, frozen shoulder, and severe arthritis
- •having a diagnosis which would interfere in the use of the device, i.e. visual impairment, active cardiac issues and palliative treatment.
结局指标
主要结局
Change from baseline Motor Activity Log (MAL)
时间窗: Change from baseline at 4 weeks
The MAL is a self-reported questionnaire designed to assess how frequently and effectively patients utilize their affected arm daily. It consists of 2 subscales to measure patients' perceived amount of arm use (MAL-AOU) and quality of arm use (MAL-QOM) (Uswatte, Taub, Morris, Light \& Thompson, 2006)
Change from preintervention at 7-week (after crossover) Active range of motion (AROM) of shoulder and elbow
时间窗: Change from 7-week at 11 weeks
The active ROM of the shoulder (flexion) and elbow (flexion/ extension) will be evaluated using a manual goniometer.
Change from preintervention at 7-week (after crossover) Motor Activity Log (MAL)
时间窗: Change from 7-week at 11 weeks
The MAL is a self-reported questionnaire designed to assess how frequently and effectively patients utilize their affected arm daily. It consists of 2 subscales to measure patients' perceived amount of arm use (MAL-AOU) and quality of arm use (MAL-QOM) (Uswatte, Taub, Morris, Light \& Thompson, 2006)
Change from baseline Fugl Meyer Upper Extremity assessment
时间窗: Change from baseline at 4 weeks
The FMA-UE is a 3-point scale with a maximum score of 66 that measures the synergistic pattern and ability to make arm movements.The total score is further subdivided into upper-extremity and hand subscores with a total score of 66 (Fugl Meyer et al., 1975)
Change from baseline Action Research Arm Test
时间窗: Change from baseline at 4 weeks
The ARAT is a frequently used assessment tool to assess hemiplegic upper limb function. It consists of 19 items comprising four domains: grasp, grip, pinch, and gross motor, and has a total score of 57 (Lyle, 1981).
Change from preintervention at 7-week (after crossover) Action Research Arm Test
时间窗: Change from 7-week at 11 weeks
The ARAT is a frequently used assessment tool to assess hemiplegic upper limb function. It consists of 19 items comprising four domains: grasp, grip, pinch, and gross motor, and has a total score of 57 (Lyle, 1981).
Change from baseline Active range of motion (AROM) of shoulder and elbow
时间窗: Change from baseline at 4 weeks
The active ROM of the shoulder (flexion) and elbow (flexion/ extension) will be evaluated using a manual goniometer.
Change from preintervention at 7-week (after crossover) Fugl Meyer Upper Extremity assessment
时间窗: Change from 7-week at 11 weeks
The FMA-UE is a 3-point scale with a maximum score of 66 that measures the synergistic pattern and ability to make arm movements.The total score is further subdivided into upper-extremity and hand subscores with a total score of 66 (Fugl Meyer et al., 1975)
次要结局
未报告次要终点
研究者
Kenneth N. K. Fong
Professor
The Hong Kong Polytechnic University