Improving Mobility Via Robotic Exoskeletons in Local Rehabilitation Settings in Singapore

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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. Outcome measures for the control group will be performed at similar time points as the intervention group, i.e., before training (i.e., after signing ICF), after training (after 12 sessions of conventional physiotherapy) and 6 months later. The application of robotic exoskeleton in rehabilitation among patients with walking impairment will also be evaluated through qualitatively exploring the perceptions of patients and therapists. The factors influencing the utilization of the robotic exoskeletons for rehabilitation among patients will also be explored.

Official Title
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Evaluating Evidence-based and Sustainable Application of Robotic Exoskeletons in Rehabilitation for Those With Impaired Mobility

Conditions
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Stroke, Spinal Cord Injuries, Spinal Cord Diseases

Intervention / Treatment
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* Device: robotic exoskeleton training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria 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. Pregnancy

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EksoGT group<br>Participants in the intervention group will receive 12 sessions of robotic exoskeleton training incorporated into their conventional physiotherapy session. | Device: robotic exoskeleton training<br>* robotic exoskeleton training using EksoGT will be incorporated into subject's conventional physiotherapy training.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional ambulatory category | 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. | baseline | 
| Functional ambulatory category | 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. | up to 12 weeks | 
| Functional ambulatory category | 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 months | 
| 10 meter walk test | Test for walking speed | baseline | 
| 10 meter walk test | Test for walking speed | up to 12 weeks | 
| 10 meter walk test | Test for walking speed | 6 months | 
| 6 minute walk test | Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded. | baseline | 
| 6 minute walk test | Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded. | up to 12 weeks | 
| 6 minute walk test | Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded. | 6 months | 
| Walking Index for Spinal Cord Injury | 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. | baseline | 
| Walking Index for Spinal Cord Injury | 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. | up to 12 weeks | 
| Walking Index for Spinal Cord Injury | 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. | 6 months | 
| clinical outcome variables scale (COVS) (for non-walkers) | 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. | baseline | 
| clinical outcome variables scale (COVS) (for non-walkers) | 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. | up to 12 weeks | 
| clinical outcome variables scale (COVS) (for non-walkers) | 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. | 6 months | 
| Cycle ergometer testing | This test is for non-walkers. | baseline | 
| Cycle ergometer testing | This test is for non-walkers. | up to 12 weeks | 
| Cycle ergometer testing | This test is for non-walkers. | 6 months | 
| Goal Attainment Scale | 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. | baseline | 
| Goal Attainment Scale | 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. | up to 12 weeks | 
| Goal Attainment Scale | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rivermead mobility index | Assess functional mobility in gait, balance and transfers after stroke. It consists of 15 items. The items are scored 0 if the patient is not able to complete the task or 1 if they are able to complete it. The points are then added together, to score a maximum of 15, with higher scores stipulating better functional mobility. | baseline | 
| Rivermead mobility index | Assess functional mobility in gait, balance and transfers after stroke. It consists of 15 items. The items are scored 0 if the patient is not able to complete the task or 1 if they are able to complete it. The points are then added together, to score a maximum of 15, with higher scores stipulating better functional mobility. | up to 12 weeks | 
| Rivermead mobility index | Assess functional mobility in gait, balance and transfers after stroke. It consists of 15 items. The items are scored 0 if the patient is not able to complete the task or 1 if they are able to complete it. The points are then added together, to score a maximum of 15, with higher scores stipulating better functional mobility. | 6 months | 
| EuroQol-5 dimension (EQ5D) | EQ-5D is a standardised measure of health-related quality of life. It consists of 5 dimensions of health- mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimensions scores from 1 to 5, with 1 indicating no problems and 5 indicating being unable to do' or extreme pain/discomfort/anxiety/depression. | baseline | 
| EuroQol-5 dimension (EQ5D) | EQ-5D is a standardised measure of health-related quality of life. It consists of 5 dimensions of health- mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimensions scores from 1 to 5, with 1 indicating no problems and 5 indicating being unable to do' or extreme pain/discomfort/anxiety/depression. | 6 months | 
| 7-day physical activity recall | for outpatient only | baseline | 
| 7-day physical activity recall | for outpatient only | up to 12 weeks | 
| 7-day physical activity recall | for outpatient only | 6 months | 
| RET satisfaction survey and feedback | For the intervention group only. Each question is scaled from 1 to 7, with 1 indicating the most negative response, while 7 indicating the most positive response. | up to 12 weeks | 
| Technology Awareness Survey | It contains 15 questions designed by the study team, to explore participants' initial view on the application of innovative technology such as robotic exoskeleton in rehabilitation, before they start the physiotherapy with RET. The result is not reported in ordinal scale. | baseline |