Evaluating Evidence-based and Sustainable Application of Robotic Exoskeletons in Rehabilitation for Those With Impaired Mobility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 2
- 主要终点
- 6 minute walk test
研究概览
简要总结
The programme is designed to investigate the application of robotic exoskeleton in different levels of local rehabilitation facilities. Feasibilities, efficacy, cost-effectiveness, patient and therapist's view of the application of robotic exoskeleton will be evaluated.
详细描述
In recent years, robot-assisted gait training has been increasingly applied in various rehabilitation facilities across Singapore. Thus far, all systems in Singapore are tethered to treadmills or other platforms. These are bulky, expensive, and the 'gait' trained differs from normal gait to varying degrees. Such systems are found only in hospitals and major centres with significant space and financial resources. No evaluation of cost-effectiveness has been performed thus far. With appropriate and efficient clinical protocols adapted and optimised for the Singapore context, study team plans to demonstrate engaging and cost-effective delivery of rehabilitation care, particularly in the community. The aims of the programme include:
- To study the feasibility of the robotic exoskeleton application in both hospital and community rehabilitation settings (inpatient and outpatient)
- To investigate if robotic exoskeletons training could improve motor outcomes in patients with impaired mobility, in the subacute and chronic phases of recovery.
- To evaluate the cost-effectiveness of robotic exoskeleton application in rehabilitation.
400 participants with impaired walking ability will be recruited at a 3:1 ratio (intervention: control) from participating centres of the iMOVE programme (Improving Mobility Via Exoskeletons) in Singapore. The iMOVE Programme is a pilot clinical programme, funded by Temasek Foundation Cares, evaluating the utility of robotic exoskeletons for the rehabilitation of mobility across the continuum of rehabilitation care.
This will be a non-randomized controlled study. Eligible participants will be asked for their willingness to undergo robotic exoskeleton training (RET). Those who decline intervention will be offered participation in the control group, where they will receive their usual care with conventional physiotherapy.
Participants in the intervention group will receive 12 sessions of RET incorporated into their conventional physiotherapy session. Typical total duration of physiotherapy is 45-60 minutes, comprising 30 minutes of RET, and 15-30 minutes of conventional physiotherapy. The training period will follow participant's own physiotherapy schedule, the frequency of which might range from 5 times a week (for inpatient) to 1-2 times a week (for outpatient). Outcome measures including measurement for functional mobility and quality of life will be performed before training, after training and 6 months post-training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 21 to 90 years old;
- •Functional Ambulatory Category (FAC) 0-3;
- •Able to follow instructions adequately to ensure safe use of the exoskeleton.
排除标准
- •Severe osteoporosis;
- •Uncontrolled medical conditions (eg. Unstable angina, untreated hypertension);
- •Terminal disease with expected survival <1 year;
- •Pressure sores or wounds at point of contact with exoskeleton;
- •Severe limitations of range of movement in the lower limb (eg. from contractures or spasticity);
- •Lower limb fractures that have not been fixed or are deemed not stable enough for training with exoskeleton;
- •Cognitive impairment so as to be unable to follow instructions;
- •Significant pain in the lower limbs.
研究组 & 干预措施
EksoGT group
Participants in the intervention group will receive 12 sessions of robotic exoskeleton training incorporated into their conventional physiotherapy session.
干预措施: robotic exoskeleton training (Device)
Control group
Participants in the control group will only undergo outcome measures assessment. They will continue with their conventional physiotherapy and the frequency and type of activity at physiotherapy will be recorded.
结局指标
主要结局
6 minute walk test
时间窗: 6 months
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
Functional ambulatory category
时间窗: 6 months
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Higher score indicates better ambulation ability.
10 meter walk test
时间窗: 6 months
Test for walking speed
Walking Index for Spinal Cord Injury
时间窗: 6 months
It is tested for patient with spinal cord injury only. It assess the amount of physical assistance needed, as well as device required, for walking following paralysis that results from Spinal Cord Injury. Scale ranges from 0 to 20. Higher scores mean a better outcome, i.e. less assistance required.
clinical outcome variables scale (COVS) (for non-walkers)
时间窗: 6 months
The COVS is an assessment scale used to quantify functional mobility status. It contains 13 items. Each item is scored on a 7-point scale ranging from 1 (fully dependent mobility) to 7 (normal independent mobility). Higher scores mean a higher mobility function.
Cycle ergometer testing
时间窗: 6 months
This test is for non-walkers.
Goal Attainment Scale
时间窗: 6 months
The Goal Attainment Scale (GAS) is an individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculated the extent to which a patient's goals are met. Each patient effectively has their own outcome measures, but these measures are scored in a standardized way: +2: much more than expected; +1: somewhat more than expected; 0: patient achieves the expected level; -1: somewhat less than expected; -2: much less than expected. The overall score is calculated by incorporating the goal scores into a single aggregated t-score. selection and goal scaling that is standardized in order to calculated the extent to which a patient's goals are met.
10 meter walk test
时间窗: baseline
Test for walking speed
10 meter walk test
时间窗: up to 12 weeks
Test for walking speed
Functional ambulatory category
时间窗: baseline
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Higher score indicates better ambulation ability.
Functional ambulatory category
时间窗: up to 12 weeks
The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. Higher score indicates better ambulation ability.
6 minute walk test
时间窗: baseline
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
6 minute walk test
时间窗: up to 12 weeks
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
Walking Index for Spinal Cord Injury
时间窗: baseline
It is tested for patient with spinal cord injury only. It assess the amount of physical assistance needed, as well as device required, for walking following paralysis that results from Spinal Cord Injury. Scale ranges from 0 to 20. Higher scores mean a better outcome, i.e. less assistance required.
Walking Index for Spinal Cord Injury
时间窗: up to 12 weeks
It is tested for patient with spinal cord injury only. It assess the amount of physical assistance needed, as well as device required, for walking following paralysis that results from Spinal Cord Injury. Scale ranges from 0 to 20. Higher scores mean a better outcome, i.e. less assistance required.
clinical outcome variables scale (COVS) (for non-walkers)
时间窗: baseline
The COVS is an assessment scale used to quantify functional mobility status. It contains 13 items. Each item is scored on a 7-point scale ranging from 1 (fully dependent mobility) to 7 (normal independent mobility). Higher scores mean a higher mobility function.
clinical outcome variables scale (COVS) (for non-walkers)
时间窗: up to 12 weeks
The COVS is an assessment scale used to quantify functional mobility status. It contains 13 items. Each item is scored on a 7-point scale ranging from 1 (fully dependent mobility) to 7 (normal independent mobility). Higher scores mean a higher mobility function.
Cycle ergometer testing
时间窗: baseline
This test is for non-walkers.
Cycle ergometer testing
时间窗: up to 12 weeks
This test is for non-walkers.
Goal Attainment Scale
时间窗: baseline
The Goal Attainment Scale (GAS) is an individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculated the extent to which a patient's goals are met. Each patient effectively has their own outcome measures, but these measures are scored in a standardized way: +2: much more than expected; +1: somewhat more than expected; 0: patient achieves the expected level; -1: somewhat less than expected; -2: much less than expected. The overall score is calculated by incorporating the goal scores into a single aggregated t-score.
Goal Attainment Scale
时间窗: up to 12 weeks
TThe Goal Attainment Scale (GAS) is an individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculated the extent to which a patient's goals are met. Each patient effectively has their own outcome measures, but these measures are scored in a standardized way: +2: much more than expected; +1: somewhat more than expected; 0: patient achieves the expected level; -1: somewhat less than expected; -2: much less than expected. The overall score is calculated by incorporating the goal scores into a single aggregated t-score.
次要结局
- Rivermead mobility index(6 months)
- EuroQol-5 dimension (EQ5D)(6 months)
- 7-day physical activity recall(6 months)
- RET satisfaction survey and feedback(up to 12 weeks)
- Technology Awareness Survey(baseline)
- Rivermead mobility index(baseline)
- Rivermead mobility index(up to 12 weeks)
- EuroQol-5 dimension (EQ5D)(baseline)
- 7-day physical activity recall(baseline)
- 7-day physical activity recall(up to 12 weeks)