Improving Mobility Via Robotic Exoskeletons in Local Rehabilitation Settings in Singapore
Condition: Stroke; Spinal Cord Injuries; Spinal Cord Diseases
MeSH terms: Spinal Cord Injuries; Spinal Cord Diseases
Study type: Interventional

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.
    

Intervention name(s): robotic exoskeleton training
Intervention type(s): Device
Intervention description(s): robotic exoskeleton training using EksoGT will be incorporated into subject's conventional physiotherapy training.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research