StrokeNCT05659121
Improving Mobility Via Robotic Exoskeletons in Local Rehabilitation Settings in Singapore
A study testing robotic exoskeleton training in people with Stroke and Spinal Cord Injuries, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Stroke, Spinal Cord Injuries, Spinal Cord Diseases
- What is being tested?
- robotic exoskeleton training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 2 sitesSingapore
- Study dates
- 15 Nov 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Cognitive impairment so as to be unable to follow instructions;
- Significant pain in the lower limbs.
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Alexandra Hospital
Singapore
National University Hospital
Singapore
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Stroke, Spinal Cord Injuries, Spinal Cord Diseases
- Being tested
- robotic exoskeleton training
- Medical subject headings
- Stroke, Spinal Cord Injuries, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic exoskeleton trainingDevice
robotic exoskeleton training using EksoGT will be incorporated into subject's conventional physiotherapy training.
| Study group | Role | What they receive |
|---|---|---|
| EksoGT group | Experimental | Participants in the intervention group will receive 12 sessions of robotic exoskeleton training incorporated into their conventional physiotherapy session. Receives: Device: robotic exoskeleton training |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
10 meter walk test
Test for walking speed
Measured: baseline
10 meter walk test
Test for walking speed
Measured: up to 12 weeks
10 meter walk test
Test for walking speed
Measured: 6 months
6 minute walk test
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
Measured: baseline
6 minute walk test
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Cycle ergometer testing
This test is for non-walkers.
Measured: baseline
Cycle ergometer testing
This test is for non-walkers.
Measured: up to 12 weeks
Cycle ergometer testing
This test is for non-walkers.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
7-day physical activity recall
for outpatient only
Measured: baseline
7-day physical activity recall
for outpatient only
Measured: up to 12 weeks
7-day physical activity recall
for outpatient only
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start15 Nov 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Temasek Foundation Cares
- Responsible party
- Sponsor
- Investigators
- Effie Chew, MBBS, Principal investigator, Senior Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659121
- Sponsor's protocol ID
- iMOVE
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Shankar R, Tang N, Shafawati N, Phan P, Mukhopadhyay A, Chew E. Cost-effectiveness analysis of robotic exoskeleton versus conventional physiotherapy for stroke rehabilitation in Singapore from a health system perspective. BMJ Open. 2025 Jul 7;15(7):e095269. doi: 10.1136/bmjopen-2024-095269.
PubMed 40623888Tam PK, Tang N, Kamsani NSB, Yap TY, Coffey-Aladdin I, Goh SM, Tan JPP, Lui YC, Lee RL, Suresh R, Chew E. Overground robotic exoskeleton vs conventional therapy in inpatient stroke rehabilitation: results from a pragmatic, multicentre implementation programme. J Neuroeng Rehabil. 2025 Jan 6;22(1):3. doi: 10.1186/s12984-024-01536-1.
PubMed 39762953
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Evidence-based and Sustainable Application of Robotic Exoskeletons in Rehabilitation for Those With Impaired Mobility
- ClinicalTrials.gov ID
- NCT05659121
- Acronym / sponsor ID
- iMOVE
- Conditions
- Stroke, Spinal Cord Injuries, Spinal Cord Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Temasek Foundation Cares
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EksoGT group | Experimental | Device: robotic exoskeleton trainingParticipants in the intervention group will receive 12 sessions of robotic exoskeleton training incorporated into their conventional physiotherapy session. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robotic exoskeleton trainingrobotic exoskeleton training using EksoGT will be incorporated into subject's conventional physiotherapy training. | Device | EksoGT group |
Primary outcome
Functional ambulatory category
Time frame: 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
Time frame: 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.
Functional ambulatory category
Time frame: 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
Time frame: baseline
Test for walking speed
10 meter walk test
Time frame: up to 12 weeks
Test for walking speed
10 meter walk test
Time frame: 6 months
Test for walking speed
6 minute walk test
Time frame: baseline
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
6 minute walk test
Time frame: up to 12 weeks
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
6 minute walk test
Time frame: 6 months
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
Walking Index for Spinal Cord Injury
Time frame: 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
Time frame: 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.
Walking Index for Spinal Cord Injury
Time frame: 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)
Time frame: 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)
Time frame: 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.
clinical outcome variables scale (COVS) (for non-walkers)
Time frame: 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
Time frame: baseline
This test is for non-walkers.
Cycle ergometer testing
Time frame: up to 12 weeks
This test is for non-walkers.
Cycle ergometer testing
Time frame: 6 months
This test is for non-walkers.
Goal Attainment Scale
Time frame: 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
Time frame: 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.
Goal Attainment Scale
Time frame: 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 secondary outcomes
Rivermead mobility index
Time frame: baseline
Rivermead mobility index
Time frame: up to 12 weeks
Rivermead mobility index
Time frame: 6 months
EuroQol-5 dimension (EQ5D)
Time frame: baseline
EuroQol-5 dimension (EQ5D)
Time frame: 6 months
7-day physical activity recall
Time frame: baseline
7-day physical activity recall
Time frame: up to 12 weeks
7-day physical activity recall
Time frame: 6 months
RET satisfaction survey and feedback
Time frame: up to 12 weeks
Technology Awareness Survey
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Derived from this study: PubMed 40623888Shankar R, Tang N, Shafawati N, Phan P, Mukhopadhyay A, Chew E. Cost-effectiveness analysis of robotic exoskeleton versus conventional physiotherapy for stroke rehabilitation in Singapore from a health system perspective. BMJ Open. 2025 Jul 7;15(7):e095269. doi: 10.1136/bmjopen-2024-095269.
- Derived from this study: PubMed 39762953Tam PK, Tang N, Kamsani NSB, Yap TY, Coffey-Aladdin I, Goh SM, Tan JPP, Lui YC, Lee RL, Suresh R, Chew E. Overground robotic exoskeleton vs conventional therapy in inpatient stroke rehabilitation: results from a pragmatic, multicentre implementation programme. J Neuroeng Rehabil. 2025 Jan 6;22(1):3. doi: 10.1186/s12984-024-01536-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Effie Chew, MBBS principal investigator
Senior Consultant
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic exoskeleton training in people with Stroke and Spinal Cord Injuries, run by National University Hospital, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional ambulatory category (time frame: baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659121, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.