Personal Exoskeleton or Manual Wheelchair: a Comparison of Performance and Satisfaction in Activities of Daily Living Among People With Spinal Cord Injuries, Using the SCED Methodology.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Compare satisfaction and performance when carrying out four activities of daily living using the EVE® exoskeleton, versus those carried out using a manual wheelchair, using the Canadian Occupational Performance Measure (COPM)
研究概览
简要总结
Spinal cord injuries resulting in paraplegia affect patients' mobility and, consequently, their ability to participate in activities of daily living. In France, according to available sources, the number of people with a symptomatic spinal cord injury is estimated to be between 97,000 and 132,000, with an average age of 55. The incidence is estimated at 1,300 new cases per year.
Following initial treatment, patients' aim is to resume their daily activities. Engaging in these activities is associated with a better quality of life and is recognised as having a positive effect on health. Limitations in their ability to move around directly affect their participation in activities of daily living and, consequently, their quality of life.
To this end, mobility can be supported by a manual wheelchair (MW) or an electric wheelchair (EW); however, these aids do not enable patients to regain the ability to stand, which remains one of the main goals for people with spinal cord injuries.
Robotic exoskeletons can assist with standing and locomotion. To date, robotic exoskeletons have been used in rehabilitation centres. During the rehabilitation phase, these devices have proven to be usable and safe for a wide range of patients with spinal cord injuries. Motorised exoskeletons thus enable patients to perform tasks such as walking, standing upright, rotating, and carrying out dynamic balance exercises.
In the longer term, personal exoskeletons, used at home, could facilitate the performance of productive, domestic, social or recreational activities, such as those carried out on a daily basis by every individual.
Personal powered exoskeletons (PPEs) also appear to generate physiological and psychosocial benefits. Studies describe potential improvements in cardiovascular health, bladder and sphincter function, and a reduced risk of osteoporosis. After a few weeks of training with a motorised exoskeleton, patients report improvements in social functioning, mental health and sub-domains of general health perception on the SF36 Walk Wheel.
It should be noted that the ability to interact socially whilst standing is an important aspect of quality of life for patients with spinal cord injuries. Patients describe the pleasure of eye contact, of being able to walk with assistance, and an improvement in mood. The PPE would complement the wheelchair by enabling ambulation and participation in activities whilst standing.
Preserving upper limb function is a prerequisite for the widespread use of walking exoskeletons in everyday life. A self-supporting PPE, such as the EVE® device, which does not require the use of crutches, aims to enable users to stand up and walk whilst retaining the use of their upper limbs. This active balance control is a crucial function for achieving many functional skills in a domestic environment. One of the technological advantages of the self-balancing exoskeleton lies in the use of dynamics to eliminate the need for crutches, whilst ensuring walking safety.
The next step towards the development of personal exoskeletons for people with spinal cord injuries is to investigate the performance of activities of daily living whilst wearing an exoskeleton. To our knowledge, no such study has been carried out, and our work addresses a gap in the scientific literature by analysing the impact of using a self-propelled PPE on satisfaction and performance when carrying out activities of daily living.
The investigators hypothesise that the personal exoskeleton leads to greater satisfaction when carrying out the four tasks of daily living, compared with that achieved using a manual wheelchair.
In this context, the KER-EXHOME clinical trial, proposed by Dr Stéphanie LEPLAIDEUR (coordinator of this study), and led by the Kerpape Centre (sponsor), aims to compare, in participants with paraplegia, satisfaction and performance when carrying out activities of daily living and physical activities, using the EVE® device compared with a manual wheelchair.
详细描述
The KER-EXHOME study is a single-case experimental design (SCED) with multiple baseline conditions. This methodology enables the analysis of data from a limited number of subjects and is based on three principles: each subject serves as their own control; frequent, repeated measurement of each subject's performance throughout the study phase; and the sequential, randomised introduction of the intervention during the study, which ensures the necessary statistical power.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical presentation of paraplegia at a level between T5 and L5 inclusive, AIS A to C inclusive
- •Secondary to a spinal cord injury (traumatic or non-traumatic) occurring more than 6 months ago, clinically and functionally stable
- •Using a manual wheelchair for indoor and outdoor mobility
- •Able to tolerate 45 minutes of standing per day
- •Anthropometric compatibility with the device (weight, height, lower limb measurements, joint ranges of motion);
- •Whether or not they have previous experience of using a PPE;
- •Participants who have signed the written consent form to take part in the study following full and informed consent
- •Participants covered by a social security scheme (beneficiary or eligible dependant) other than the AME.
排除标准
- •Osteoporosis with a T-score < -2.5 at the femoral neck, as shown by a bone densitometry scan carried out within the last 12 months.
- •History of osteoporotic fracture(s)
- •Condition or treatment causing secondary osteoporosis (known thyroid disorder, known hypogonadism, known chronic gastrointestinal disease (ulcerative colitis and Crohn's disease), corticosteroid therapy, use of bisphosphonates for more than three months, early menopause (before the age of 45), abnormal calcium metabolism test results)
- •Progressive intercurrent conditions: pressure ulcers, infection, venous thrombosis
- •Cardiovascular or pulmonary conditions contraindicating exercise (e.g. heart failure or coronary artery disease within the last 6 months)
- •Untreated or uncontrolled hypertension (SBP > 140 mmHg; DBP > 90 mmHg);
- •Unresolved orthostatic hypotension (SBP < 90 mmHg; DBP < 60 mmHg) or deemed contraindicated by the investigator;
- •Unconsolidated or unstable bone lesions of the spine, limbs or pelvis
- •Known syringomyelia, as determined by medical assessment
- •Progressive osteoma, as determined by medical assessment
- •Severe spasticity of the adductor muscles, hamstrings, quadriceps and triceps surae (greater than 3 on the modified Ashworth scale)
- •Decompensated psychiatric or cognitive disorders that may interfere with the proper use of the device
- •Wearing of an active implantable device An uncorrectable leg-length discrepancy of more than 2 cm when using additional corrective aids
- •Uncontrolled autonomic dysreflexia
- •Skin lesions at points of contact with the PPE (e.g. bruising, skin abrasions, etc.)
- •Need to use a respiratory support device whilst using Eve
- •Inability to operate the device effectively using a manual control interface, due to a functional and/or cognitive impairment, based on the ability to move the joystick in all directions, press and identify the buttons on the manual control interface.
- •Incorrect positioning of the participant in the device (excessive pressure on the support point).
- •Participant deprived of liberty (by court order or administrative decision)
- •Participant of legal age subject to a legal protection order or unable to give informed consent
- •Participation in another ongoing clinical trial
- •Pregnant or breastfeeding women, or women of childbearing age not using contraception
- •Lack of proficiency in spoken and written French
研究组 & 干预措施
Carrying out tasks using the EVE exoskeleton and a manual wheelchair.
Training Phase, Week 1
The training phase for operating the EVE® exoskeleton covers the following functions (designed to ensure that the participant is trained in the use of the EVE® exoskeleton):
- Standing up;
- Testing in free mode;
- Walking;
- Turning round;
- Half-squat;
- Using precision mode;
- Sitting down;
- Carrying out emergency extraction training;
- Archery training, if the participant has no prior experience. Participants will undergo training over 5 sessions, each lasting at least 60 minutes, spread over one week. A minimum of 5 hours' training is required to ensure safety.
Intervention phase, weeks 2 to 4 During this phase, participants will have a 3½-hour session every day (Monday to Friday). During each session, tasks will need to be carried out using the EVE® exoskeleton and the manual wheelchair.
干预措施: Carrying out tasks using the EVE exoskeleton and a manual wheelchair. (Device)
结局指标
主要结局
Compare satisfaction and performance when carrying out four activities of daily living using the EVE® exoskeleton, versus those carried out using a manual wheelchair, using the Canadian Occupational Performance Measure (COPM)
时间窗: Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25
The Canadian Occupational Performance Measure (COPM) will be used to compare perceived satisfaction and performance when carrying out identified activities of daily living using either the EVE® exoskeleton or a manual wheelchair. Using the COPM, satisfaction and performance are assessed on a scale of 1 to 10 (1 = very poor performance and satisfaction, 10 = full performance and satisfaction). MCRO scores show a significant improvement between the start and end of treatment; in the SCI validation study, the average improvement reported is approximately 4.25 points (Performance) and 2.96 points (Satisfaction) between two measurement points. The MCRO will be carried out at the end of each session using one of the devices (wheelchair or exoskeleton). Two assessments must be carried out per half-day.
次要结局
- Compare user-assessed performance with clinician-assessed performance, using the Performance Quality Rating Scale (PQRS)(Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25)
- Time taken to complete each task (in seconds).(Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25)
- To evaluate the user's perception of the ease of use of the EVE® exoskeleton, using the System Usability Scale (SUS)(Intervention phase (Week 2 to 4) : Day 12, Day 19, Day 26)
- To assess the psychosocial impact of the EVE® exoskeleton using the French-Canadian version of the F-PIADS scale, which measures the psychosocial impact of an assistive device.(End of the intervention phase (week 4) : Day 26)
- Assess the perceived exertion involved in performing four everyday tasks using the Rate of Perceived Exertion (RPE) scale.(Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25)
- Assessing the reliability of the EVE® exoskeleton.(Intervention phase (Week 2 to 4) : Day 8, Day 9, Day 10, Day 11, Day 12, Day 15, Day 16, Day 17, Day 18, Day 19, Day 22, Day 23, Day 24, Day 25)