Improving Mobility Via Robotic Exoskeletons in Local Rehabilitation Settings in Singapore

NCT05659121 | Completed DMC FDA Device

• 1 other identifier: iMOVE
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke; Spinal Cord Injuries; Spinal Cord Diseases

Outcome Measures

Primary Outcomes (21)

• 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

• 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

• 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

• 10 meter walk test

  Test for walking speed

  baseline

• 10 meter walk test

  Test for walking speed

  up to 12 weeks

• 10 meter walk test

  Test for walking speed

  6 months

• 6 minute walk test

  Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.

  baseline

• 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

• 6 minute walk test

  Test for walking endurance. Distance covered in 6 minutes with participant's comfortable walking speed will be recorded.

  6 months

• 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

• 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

• 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

• 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

• 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

• 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

• Cycle ergometer testing

  This test is for non-walkers.

  baseline

• Cycle ergometer testing

  This test is for non-walkers.

  up to 12 weeks

• Cycle ergometer testing

  This test is for non-walkers.

  6 months

• 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

• 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

• 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 Outcomes (10)

• Rivermead mobility index

  baseline

• Rivermead mobility index

  up to 12 weeks

• Rivermead mobility index

  6 months

• EuroQol-5 dimension (EQ5D)

  baseline

• EuroQol-5 dimension (EQ5D)

  6 months

Other Outcomes (1)

• semi-structured interview

  up to 12 weeks

Study Arms (2)

EksoGT group

EXPERIMENTAL

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

Device: robotic exoskeleton training

Control group

NO INTERVENTION

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.

Interventions

robotic exoskeleton training DEVICE

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

EksoGT group

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Temasek Foundation Cares: collaborator

Study Sites (2)

Alexandra Hospital

Singapore, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Related Publications (2)

• Shankar R, Tang N, Shafawati N, Phan P, Mukhopadhyay A, Chew E. Cost-effectiveness analysis of robotic exoskeleton versus conventional physiotherapy for stroke rehabilitation in Singapore from a health system perspective. BMJ Open. 2025 Jul 7;15(7):e095269. doi: 10.1136/bmjopen-2024-095269.

  PMID: 40623888 DERIVED

• Tam PK, Tang N, Kamsani NSB, Yap TY, Coffey-Aladdin I, Goh SM, Tan JPP, Lui YC, Lee RL, Suresh R, Chew E. Overground robotic exoskeleton vs conventional therapy in inpatient stroke rehabilitation: results from a pragmatic, multicentre implementation programme. J Neuroeng Rehabil. 2025 Jan 6;22(1):3. doi: 10.1186/s12984-024-01536-1.

  PMID: 39762953 DERIVED

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Effie Chew, MBBS

  Senior Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: December 21, 2022
• Study Start: November 15, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 3, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)