Clinical trial NCT05659121: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spinal Cord Injuries
Spinal Cord Diseases
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Temasek Foundation Cares
First posted: 2022-12-21
Enrollment: 375
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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.

Eligibility 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

Primary outcomes:
measure: Functional ambulatory category
timeFrame: baseline
measure: Functional ambulatory category
timeFrame: up to 12 weeks
measure: Functional ambulatory category
timeFrame: 6 months
measure: 10 meter walk test
timeFrame: baseline
measure: 10 meter walk test
timeFrame: up to 12 weeks
measure: 10 meter walk test
timeFrame: 6 months
measure: 6 minute walk test
timeFrame: baseline
measure: 6 minute walk test
timeFrame: up to 12 weeks
measure: 6 minute walk test
timeFrame: 6 months
measure: Walking Index for Spinal Cord Injury
timeFrame: baseline
measure: Walking Index for Spinal Cord Injury
timeFrame: up to 12 weeks
measure: Walking Index for Spinal Cord Injury
timeFrame: 6 months
measure: clinical outcome variables scale (COVS) (for non-walkers)
timeFrame: baseline
measure: clinical outcome variables scale (COVS) (for non-walkers)
timeFrame: up to 12 weeks
measure: clinical outcome variables scale (COVS) (for non-walkers)
timeFrame: 6 months
measure: Cycle ergometer testing
timeFrame: baseline
measure: Cycle ergometer testing
timeFrame: up to 12 weeks
measure: Cycle ergometer testing
timeFrame: 6 months
measure: Goal Attainment Scale
timeFrame: baseline
measure: Goal Attainment Scale
timeFrame: up to 12 weeks
measure: Goal Attainment Scale
timeFrame: 6 months
Secondary outcomes:
measure: Rivermead mobility index
timeFrame: baseline
measure: Rivermead mobility index
timeFrame: up to 12 weeks
measure: Rivermead mobility index
timeFrame: 6 months
measure: EuroQol-5 dimension (EQ5D)
timeFrame: baseline
measure: EuroQol-5 dimension (EQ5D)
timeFrame: 6 months
measure: 7-day physical activity recall
timeFrame: baseline
measure: 7-day physical activity recall
timeFrame: up to 12 weeks
measure: 7-day physical activity recall
timeFrame: 6 months
measure: RET satisfaction survey and feedback
timeFrame: up to 12 weeks
measure: Technology Awareness Survey
timeFrame: baseline
Other outcomes:
measure: semi-structured interview
timeFrame: up to 12 weeks
Locations:
city: Singapore
country: Singapore
facility: Alexandra Hospital
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: Senior Consultant
name: Effie Chew, MBBS
role: PRINCIPAL_INVESTIGATOR
References: