Improving Mobility Via Robotic Exoskeletons in Local Rehabilitation Settings in Singapore

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Spinal Cord Diseases; Spinal Cord Injuries
• Intervention / Treatment: Device: robotic exoskeleton training

Detailed Description

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:

1. To study the feasibility of the robotic exoskeleton application in both hospital and community rehabilitation settings (inpatient and outpatient)
2. To investigate if robotic exoskeletons training could improve motor outcomes in patients with impaired mobility, in the subacute and chronic phases of recovery.
3. 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.

• Study Type: Interventional
• Enrollment (Actual): 375
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • National University Hospital
  • Singapore, Singapore
    • Alexandra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 21 to 90 years old;
2. Functional Ambulatory Category (FAC) 0-3;
3. Able to follow instructions adequately to ensure safe use of the exoskeleton.

Exclusion Criteria

1. Severe osteoporosis;
2. Uncontrolled medical conditions (eg. Unstable angina, untreated hypertension);
3. Terminal disease with expected survival <1 year;
4. Pressure sores or wounds at point of contact with exoskeleton;
5. Severe limitations of range of movement in the lower limb (eg. from contractures or spasticity);
6. Lower limb fractures that have not been fixed or are deemed not stable enough for training with exoskeleton;
7. Cognitive impairment so as to be unable to follow instructions;
8. Significant pain in the lower limbs.
9. Pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
semi-structured interview	To explore the perceptions of the robotic exoskeleton and the factors influencing the utilization of robotic exoskeletons for rehabilitation among users.	up to 12 weeks

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Collaborators: Temasek Foundation Cares
• Investigators: Principal Investigator: Effie Chew, MBBS, Senior consultant

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: iMOVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes