Investigating the Effect of Motor Imagery With or With no Visual Neurofeedback on Grasping Capabilities After C6-C7 Tetraplegia: a Multicentric Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Wrist extension angle in degree during grasping with 3D motion analysis system
研究概览
简要总结
Motor imagery has shown promising results to optimize tenodesis grasp in individuals with C6-C7 tetraplegia. However, efficacy of using motor imagery to improve grasping after tetraplegia requires further study with higher level of evidence. In addition, controlling covert practice remains difficult due to the absence of overt movements. However, similar brain activity measured during both over and cover movements makes possible to provide visual information about the covert practice performance using neurofeedback.
The Investigators thus designed this multicentric randomized controlled trial to investigate the effect of motor imagery with or with no visual neurofeedback on grasping capabilities after C6-C7 tetraplegia. They hypothesized that providing neurofeedback based on brain activity measured by electroencephalography namely knowing the covert practice performance would results in greater grasping improvement in response to practice as compared to motor imagery practice alone.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer individuals with C6-C7 tetraplegia with complete finger flexor paralysis restricting grasping capabilities to the tenodesis.
- •Consent to participate to the study after receiving clear, loyal and appropriate information.
- •Aged between 18 and 55 years.
- •Time since spinal cord injury above 6 months
- •Stabilized condition in particular sensori-motor deficit.
- •Sitting position for more than 1 hour
- •Able to imagine movement
- •Health care beneficiary
排除标准
- •Long-lasting autonomic disorders while sitting (orthostatic hypotension and/or blood pressure instability) limiting sitting position to less than 1 hour.
- •Upper limb pain for either mechanic or neuropathic reasons preventing all grasping movement and/or the ability to imagine those movements.
- •Restricted wrist and finger range of motion preventing the tenodesis grasp.
- •Patient after surgical tendon transfer that improved grasping capabilities (e.g. active finger flexion).
- •Ongoing participation in another research that aim to evaluate an intervention likely to improve the neurological or functional recovery introducing an experimental bias.
- •Specific contraindication to Magnetoencephalography with the presence of metallic fragments inside the body such as pace-maker, neurostimulator, cochlear implants, steel dental implant and osteosynthesis material only applicable to the participants included in Lyon hospital center (n=15).
结局指标
主要结局
Wrist extension angle in degree during grasping with 3D motion analysis system
时间窗: Up to 19 weeks
Individuals with C6-C7 tetraplegia extend their wrist to grasp using tenodesis. Specifically, the wrist extension shortens the tendons of fingers and thumbs flexors that elicit either a palmar or a lateral grip. A complete reach-to-grasp movement will be recorded using a 3D motion analysis system (Vicon Motion Systems Ltd. UK). Wrist extension angle in degree will be measure during grasping when the object is grasped.
次要结局
- Hand dexterity measured using the Jebsen test(Up to 19 weeks)
- Temporal kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).(Up to 19 weeks)
- Hand dexterity measured using the Box and Block test(Up to 19 weeks)
- Hand dexterity measured using the Nine Hole Peg test(Up to 19 weeks)
- Hand dexterity measured using the Capability of Upper Limb test(Up to 19 weeks)
- Spatial kinematic parameters of reach-to-grasp movements with 3D motion analysis system (Vicon Motion Systems Ltd. UK).(Up to 19 weeks)
- Upper limb strength measured using the manual muscle test(Up to 19 weeks)
- Quality of Life measured using the WHOQOL-Bref(Up to 19 weeks)
- Brain activity change in response to intervention using magnetoencephalography(Up to 19 weeks)
- passive upper limb range of motion (ROM) measured using goniometer and/or inclinometer(Up to 19 weeks)
- Upper limb strength measured using the hand held dynamometer(Up to 19 weeks)
- Daily life autonomy measured using the Quadriplegic Index of Function(Up to 19 weeks)
- Motor imagery capability measured by the Kinesthetic Visual Imagery Questionnaire(Up to 19 weeks)