Effects of Early Sleep After Action Observation and Motor Imagery in Patients Undergoing Immobilization After Surgery for Metacarpal and Phalangeal Fractures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 51
- 主要终点
- Changes in Purdue Pegboard Test
研究概览
简要总结
The study aimed to investigate the effects of early sleep after action observation and motor imagery (AOMI) training sessions on manual dexterity in patients with hand immobilization after surgical fixation for metacarpals and phalanges fractures.
Fifty-one patients with hand immobilization for surgical fixation of IV or V metacarpals or first phalanges fractures will be randomized into AOMI-sleep (n=17), AOMI-control (n=17), and Control (n=17) group. AOMI-sleep and AOMI-control groups will perform an AOMI-training before sleeping or in the morning respectively, while Control group will be asked to observe landscape video-clips. Participants will be assessed for manual dexterity, hand range of motion, hand disability and quality of life at baseline before and after the training and at 1 month after the training end.
详细描述
The study aimed to investigate the effects of early sleep after action observation and motor imagery (AOMI) training sessions on manual dexterity in patients with hand immobilization after surgical fixation for metacarpals and phalanges fractures.
Fifty-one patients with right hand immobilization for surgical fixation of IV or V metacarpals or first phalanges fractures will be randomized into an AOMI-sleep (n=17), AOMI-control (n=17), and Control (n=17) group. AOMI-sleep and AOMI-control groups will perform a 2-week AOMI-training including transitive manual dexterity tasks between 8:00 and 10:00 p.m. or between 8:00 and 10:00 a.m. respectively, while Control group participants will be asked to observe landscape video-clips between 8:00 and 10:00 p.m. Participants will be assessed for manual dexterity (Purdue Pegboard Test and kinematic indexes during Nine Hole Peg Test), hand range of motion (Total Active Motion) hand disability (Quick-DASH) and quality of life (EQ5D) at baseline (1 week after surgery), training end (3 weeks after surgery) and 1 month after the training end (7 weeks after surgery).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical fixation for IV or V MTC or P1 fracture at the level of the right hand
- •Age 18-40 years old
- •Right-hand dominance
排除标准
- •Damage to additional hand structure requiring surgery (e.g. tendons, ligaments and nerves)
- •Occurrence of left upper limb injuries
- •Post-surgical complications (e.g. CPRS)
- •Immobilization <12 or >30 days
- •Diagnosis of neurological/musculoskeletal conditions
- •Sports or activities requiring advanced manual skills or sleep deprivation
- •History of psychiatric disorders
- •Sleep disorders (e.g. insomnia, OSAS, REN or Non-REM behavioural disorders)
- •Medication affecting the physiological sleep pattern
研究组 & 干预措施
Control
Observation and imagination of landscapes video-clips
干预措施: Control (Behavioral)
AOMI-control
Observation and imagination of video-clips with motor contents in the morning
干预措施: Action observation plus motor imagery (Behavioral)
AOMI-sleep
Observation and imagination of video-clips with motor contents before sleeping
干预措施: Action observation plus motor imagery followed by sleep (Behavioral)
结局指标
主要结局
Changes in Purdue Pegboard Test
时间窗: Before and after 2 weeks of training and at 1 month follow-up
Manual dexterity test
次要结局
- Changes in Visual Analogue Scale(Before and after 2 weeks of training and at 1 month follow-up)
- Hand-grip strength(1-month follow-up)
- Changes in EQ5D(Before and after 2 weeks of training and at 1 month follow-up)
- Changes in kinematic indexes during Nine Hole Peg Test(Before and after 2 weeks of training and at 1 month follow-up)
- Changes in Quick-DASH(Before and after 2 weeks of training and at 1 month follow-up)
- Changes in Total Active Motion(Before and after 2 weeks of training and at 1 month follow-up)