Improving Mobility Via Robotic Exoskeletons in Local Rehabilitation Settings in Singapore

National University Health System (NUHS)

Status: Completed

Conditions: Spinal Cord Injuries; Stroke; Spinal Cord Diseases

Treatments: Device: robotic exoskeleton training

Study type: Interventional

Funder types: Other

Identifiers

NCT05659121

iMOVE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 375 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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375 participants in 2 patient groups

EksoGT group

Experimental group

Description:

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

Treatment:

Device: robotic exoskeleton training

Control group

No Intervention group

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.