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Improving Mobility Via Robotic Exoskeletons in Local Rehabilitation Settings in Singapore

Primary Purpose

Stroke, Spinal Cord Injuries, Spinal Cord Diseases

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
robotic exoskeleton training
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alexandra Hospital
  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EksoGT group

Control group

Arm Description

Participants in the intervention group will receive 12 sessions of robotic exoskeleton training incorporated into their conventional physiotherapy session.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
10 meter walk test
Test for walking speed
10 meter walk test
Test for walking speed
10 meter walk test
Test for walking speed
6 minute walk test
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
6 minute walk test
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
6 minute walk test
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
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.
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.
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.
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.
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.
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.
Cycle ergometer testing
This test is for non-walkers.
Cycle ergometer testing
This test is for non-walkers.
Cycle ergometer testing
This test is for non-walkers.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
7-day physical activity recall
for outpatient only
7-day physical activity recall
for outpatient only
7-day physical activity recall
for outpatient only
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.
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.

Full Information

First Posted
April 14, 2022
Last Updated
March 2, 2023
Sponsor
National University Hospital, Singapore
Collaborators
Temasek Foundation Cares
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1. Study Identification

Unique Protocol Identification Number
NCT05659121
Brief Title
Improving Mobility Via Robotic Exoskeletons in Local Rehabilitation Settings in Singapore
Official Title
Evaluating Evidence-based and Sustainable Application of Robotic Exoskeletons in Rehabilitation for Those With Impaired Mobility
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
Collaborators
Temasek Foundation Cares

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spinal Cord Injuries, Spinal Cord Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EksoGT group
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive 12 sessions of robotic exoskeleton training incorporated into their conventional physiotherapy session.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
robotic exoskeleton training
Intervention Description
robotic exoskeleton training using EksoGT will be incorporated into subject's conventional physiotherapy training.
Primary Outcome Measure Information:
Title
Functional ambulatory category
Description
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.
Time Frame
baseline
Title
Functional ambulatory category
Description
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.
Time Frame
up to 12 weeks
Title
Functional ambulatory category
Description
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.
Time Frame
6 months
Title
10 meter walk test
Description
Test for walking speed
Time Frame
baseline
Title
10 meter walk test
Description
Test for walking speed
Time Frame
up to 12 weeks
Title
10 meter walk test
Description
Test for walking speed
Time Frame
6 months
Title
6 minute walk test
Description
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
Time Frame
baseline
Title
6 minute walk test
Description
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
Time Frame
up to 12 weeks
Title
6 minute walk test
Description
Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.
Time Frame
6 months
Title
Walking Index for Spinal Cord Injury
Description
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.
Time Frame
baseline
Title
Walking Index for Spinal Cord Injury
Description
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.
Time Frame
up to 12 weeks
Title
Walking Index for Spinal Cord Injury
Description
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.
Time Frame
6 months
Title
clinical outcome variables scale (COVS) (for non-walkers)
Description
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.
Time Frame
baseline
Title
clinical outcome variables scale (COVS) (for non-walkers)
Description
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.
Time Frame
up to 12 weeks
Title
clinical outcome variables scale (COVS) (for non-walkers)
Description
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.
Time Frame
6 months
Title
Cycle ergometer testing
Description
This test is for non-walkers.
Time Frame
baseline
Title
Cycle ergometer testing
Description
This test is for non-walkers.
Time Frame
up to 12 weeks
Title
Cycle ergometer testing
Description
This test is for non-walkers.
Time Frame
6 months
Title
Goal Attainment Scale
Description
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.
Time Frame
baseline
Title
Goal Attainment Scale
Description
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.
Time Frame
up to 12 weeks
Title
Goal Attainment Scale
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rivermead mobility index
Description
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.
Time Frame
baseline
Title
Rivermead mobility index
Description
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.
Time Frame
up to 12 weeks
Title
Rivermead mobility index
Description
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.
Time Frame
6 months
Title
EuroQol-5 dimension (EQ5D)
Description
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.
Time Frame
baseline
Title
EuroQol-5 dimension (EQ5D)
Description
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.
Time Frame
6 months
Title
7-day physical activity recall
Description
for outpatient only
Time Frame
baseline
Title
7-day physical activity recall
Description
for outpatient only
Time Frame
up to 12 weeks
Title
7-day physical activity recall
Description
for outpatient only
Time Frame
6 months
Title
RET satisfaction survey and feedback
Description
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.
Time Frame
up to 12 weeks
Title
Technology Awareness Survey
Description
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.
Time Frame
baseline
Other Pre-specified Outcome Measures:
Title
semi-structured interview
Description
To explore the perceptions of the robotic exoskeleton and the factors influencing the utilization of robotic exoskeletons for rehabilitation among users.
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Effie Chew, MBBS
Organizational Affiliation
Senior Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandra Hospital
City
Singapore
Country
Singapore
Facility Name
National University Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No

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Improving Mobility Via Robotic Exoskeletons in Local Rehabilitation Settings in Singapore

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