Improving Mobility Via Robotic Exoskeletons in Local Rehabilitation Settings in Singapore

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659121
• Other study ID #: iMOVE
• Status: Completed
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Diseases
• Spinal Cord Injuries
• Stroke

Intervention

Device:
• robotic exoskeleton training
robotic exoskeleton training using EksoGT will be incorporated into subject's conventional physiotherapy training.

Locations

Country	Name	City	State
Singapore	Alexandra Hospital	Singapore
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Temasek Foundation Cares

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	10 meter walk test	Test for walking speed	baseline
Primary	10 meter walk test	Test for walking speed	up to 12 weeks
Primary	10 meter walk test	Test for walking speed	6 months
Primary	6 minute walk test	Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.	baseline
Primary	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
Primary	6 minute walk test	Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.	6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cycle ergometer testing	This test is for non-walkers.	baseline
Primary	Cycle ergometer testing	This test is for non-walkers.	up to 12 weeks
Primary	Cycle ergometer testing	This test is for non-walkers.	6 months
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	7-day physical activity recall	for outpatient only	baseline
Secondary	7-day physical activity recall	for outpatient only	up to 12 weeks
Secondary	7-day physical activity recall	for outpatient only	6 months
Secondary	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
Secondary	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