Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-90
SponsorTan Tock Seng Hospital
About this trial
There has been an observed decrease in motor and functional ability and non-use of the impaired limb in chronic patients. This is due to the immediate drop in intensive daily therapy (5 days per week for 3 hours/day) that is usually provided during the inpatient (acute) phase upon discharge from the hospital.
In this study, the investigators plan to address the low dosage of therapy in the post-acute discharge phase for stroke survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and CT, CT angiography or MRI brain imaging.
Age 21 to 90 years, both males and females.
At least > 28 days post stroke.
Upper limb motor impairment of Fugl-Myer Motor Assessment (FMA) scale 10 to 60
Disqualifiers
Non-stroke related causes of arm motor impairment.
Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, end stage renal/liver/heart/lung failure, unresolved cancers.
Anticipated life expectancy of < 6 months.
Inability to tolerate sitting continuously for 60 minutes.
Trial design
Design model
Single group
Treatments tested in this trial
HMAN Robot
DeviceThe HMAN is certified as a CE class 2A upper limb rehabilitation robot suitable for hospital, clinic and home-based use in 2020 by Health Sciences Authority, Singapore. It has since been employed in post-stroke neurorehabilitation therapy and assessment of sensorimotor functions in stroke patients.
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: HMAN robot @ HomeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Compliance Rates
Using cloud data from vendor, time (min/hours) of HMAN robot usage
Time frame
Through study's data collection period, up to 2 yearsSecondary outcomes
1
Fugl Meyer Motor Assessment (FMA)
Change in Fugl Meyer Motor Assessment score in the affected arm
Time frame
Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)2
Action Research Arm Test (ARAT)
Functional and dexterity score for upper extremities, minimum 0, maximum 57; with higher score indicating better function
Time frame
Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)3
Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded)
Measured by Digital Dynamometer (mean of 3 readings will be recorded)
Time frame
Weeks 0 (baseline), Week 6 (end of HMAN @ Home), Week 8 (end of treatment phase), Week 12 (1st Follow-up), Week 24 (Last follow-up)4
System Usability Scale (SUS)
For evaluation of the HMAN robot's perceived usability, scaled from 1 (Strongly disagree) to 5 (Strongly Agree)
Time frame
Week 6 (end of HMAN @ Home)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tan Tock Seng Hospital
Lead sponsor
National University Hospital, Singapore
Collaborator
Singapore General Hospital
Collaborator
Source ClinicalTrials.gov