Stroke Clinical Trial
Official title:
Smart Rehabilitation Exosuits for Clinic and Home Assistance
Verified date | November 2021 |
Source | Tan Tock Seng Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim is to do a feasibility and refinement trial to assess the safety and comfort of the robotic device and their preliminary effect on muscular activity during the performance of activities of daily living. The study was carried out with 10 stroke participants who had to carry out a series of 10 functional tasks with and without the suit over 3 sessions. The results are encouraging and show the potential of using wearable robotic devices in a clinical setting.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 31, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patient with motor deficit(s) due to stroke as diagnosed by CT or MRI, who are attending outpatient rehabilitation services at TTSH Rehabilitation Centre and Centre for Advanced Rehabilitation Therapeutics; - Patient with first ever clinical stroke (confirmed on brain imaging); - Post stroke of at least 3 months with stable neurological status; - Age between 21 to 80 years, inclusive; - Hemiplegic pattern and shoulder abduction Medical Research Council motor power > 2/5; - Able to give and sign informed consent at research site; - Montreal Cognitive Assessment >= 22/30. Exclusion Criteria: - Patient with severe cognitive, perceptual (include hemi-neglect), and/or emotional-behavioural issues that preclude participation; - Experiencing moderate to severe levels of pain (visual numeric pain rating scale > 5); - Has unstable or terminal medical conditions which may affect participation (e.g. unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life expectancy of < 1 year due to malignancy or neurodegenerative disorder; - Non-stroke related causes of arm motor impairment; - Local factors which may be worsened by arm therapy or device interface: spasticity of MAS > 3, unhealed skin wounds/rashes, shoulder pain visual analog scale > 5/10, active fractures or arthritis or fixed flexion contractures of shoulder, elbow, wrist or fingers incompatible with device interface; - Inability to tolerate 90 minutes of therapy session; - Pregnancy or breast feeding; - Detectable sensory impairment of affected limb---hemianesthesia to sharp pain. |
Country | Name | City | State |
---|---|---|---|
Singapore | Tan Tock Seng Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Tan Tock Seng Hospital | Nanyang Technological University |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of the elbow module by self-reported evaluation via questionnaire | Patient self-reported outcome of the ease of use, ranked from 1 to 5, 5 being the easiest and 1 being the least easy. | End of the 3rd session, median duration of 5 days from baseline | |
Primary | Assessment of the hand module by self-reported evaluation via questionnaire | Patient self-reported outcome of the ease of use, ranked from 1 to 5, 5 being the easiest and 1 being the least easy. | End of the 3rd session, median duration of 5 days from baseline | |
Primary | Successful completion of tasks (without intervention) | The success of the tasks without the assistance of the exoskeletons was evaluated by the clinician. | At 2nd session, median time of 2 days from baseline | |
Primary | Successful completion of tasks (with intervention) | The success of the tasks with the assistance of the exoskeletons was evaluated by the clinician. | At 3rd session, median time of 5 days from baseline | |
Secondary | Upper limb angular trajectory (without intervention) | The upper limb angular trajectories while not wearing the exoskeletons were measured via Inertial Measurement Units (IMUs) to investigate changes in movements of the elbow and shoulder joints. | Average over the 2nd session, median time of 2 days from baseline | |
Secondary | Upper limb angular trajectory (with intervention) | The upper limb angular trajectories while wearing the exoskeletons were measured via Inertial Measurement Units (IMUs) to investigate changes in movements of the elbow and shoulder joints. | Average over the 3rd session, median time of 5 days from baseline | |
Secondary | Muscular synergies (without intervention) | The muscular synergies of the users while not wearing the exoskeletons were measured by calculating Pearson's correlation coefficient between muscles. | Average over the 2nd session, median time of 2 days from baseline | |
Secondary | Muscular synergies (with intervention) | The muscular synergies of the users while wearing the exoskeletons were measured by calculating Pearson's correlation coefficient between muscles. | Average over the 3rd session, median time of 5 days from baseline | |
Secondary | Muscular effort (without intervention) | The muscular efforts of the users while not wearing the exoskeletons were measured by surface electromyographic sensors (sEMG), and normalised against the maximum voluntary contraction (MVC) value obtained at the beginning of the session. | Average over the 2nd session, median time of 2 days from baseline | |
Secondary | Muscular effort (with intervention) | The muscular efforts of the users while wearing the exoskeletons were measured by surface electromyographic sensors (sEMG), and normalised against the maximum voluntary contraction (MVC) value obtained at the beginning of the session. | Average over the 3rd session, median time of 5 days from baseline |
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