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Upper Limb Exosuit for Clinic Assistance

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Custom-made upper limb exosuit and hand exoskeleton
Sponsored by
Tan Tock Seng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Stroke focused on measuring exoskeleton, robot, stroke, upper limb, hand, assistance

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tan Tock Seng Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Refinement and Feasibility Trial

Arm Description

It is intra - individual comparison study Arm 1: participant wore the custom-made upper limb exosuit and hand exoskeleton to perform the series of tasks Arm 0: participant perform the same tasks without the custom-made upper limb exosuit and hand exoskeleton.

Outcomes

Primary Outcome Measures

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.
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.
Successful completion of tasks (without intervention)
The success of the tasks without the assistance of the exoskeletons was evaluated by the clinician.
Successful completion of tasks (with intervention)
The success of the tasks with the assistance of the exoskeletons was evaluated by the clinician.

Secondary Outcome Measures

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.
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.
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.
Muscular synergies (with intervention)
The muscular synergies of the users while wearing the exoskeletons were measured by calculating Pearson's correlation coefficient between muscles.
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.
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.

Full Information

First Posted
September 30, 2021
Last Updated
November 3, 2021
Sponsor
Tan Tock Seng Hospital
Collaborators
Nanyang Technological University
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1. Study Identification

Unique Protocol Identification Number
NCT05118321
Brief Title
Upper Limb Exosuit for Clinic Assistance
Official Title
Smart Rehabilitation Exosuits for Clinic and Home Assistance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tan Tock Seng Hospital
Collaborators
Nanyang Technological University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Each participant completed 3 ninety-minute long sessions at CART over the course of a week. All participants were closely supervised by 1 occupational therapist and 1 engineer involved in the development of the devices. In the first session, screening of the patient was performed, where the patient's demographics and clinical parameters were collected, including the grip strength of the affected hand measured by a hand dynamometer taking the mean of 2 attempts, and MOCA, FMA and MAS scores. Afterwards, a familiarisation phase was conducted, where the participant trialled the robotic devices to understand their mechanisms and learn how to use them. This phase also allowed the researchers to adjust the fitting of the exoskeletons and tuning the control algorithm of the elbow exoskeleton to the biomechanics of each user, in order to achieve best comfort and assistance. The participants were instructed to perform a series of elbow/finger flexion and extension movements to understand how to control the exoskeletons. The participants also interacted with different objects (cup, cube, ball) to adjust the positioning of the anchor points in the glove to the position the participants felt most comfortable with. Once the optimised fitting of the devices was identified, the obtained parameters were stored, and the configuration of the devices was left unchanged for reuse in the next session. In the 2 remaining sessions, participants performed a series of 10 functional tasks. The tasks were performed without assistance (NO-EXO condition) and with assistance (EXO condition) of the exoskeletons. The tasks were performed first in the unpowered condition to allow the participants to familiarise themselves with the tasks before performing them with the assistance of the devices. The participants were instructed to start every attempt at a task from a position marked on the floor, and with their arms fully relaxed. This was to ensure that variability from unknown factors was minimised. The participants then awaited the instruction from the researchers to commence the task, given in the form of a spoken command triggered by the press of a button. The button was pressed again to signal the end of the task, defined by the following in order of priority: 1) participant decided to stop; 2) the participant dropped the object; 3) therapist decided to stop after deciding the participant was experiencing difficulties and further attempts would not contribute to a successful performance of the task; 4) task is successfully completed. In addition to the performance of functional tasks, the standing horizontal fingertip reaching distance and the elbow ROM were measured using a measuring tape and a goniometer, respectively. At the end of the 3rd session, the participants were asked to fill up a questionnaire to provide their subjective feedback regarding comfort, ergonomics, ease of use, overall clinical benefit and user satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
exoskeleton, robot, stroke, upper limb, hand, assistance

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Refinement and Feasibility Trial
Arm Type
Other
Arm Description
It is intra - individual comparison study Arm 1: participant wore the custom-made upper limb exosuit and hand exoskeleton to perform the series of tasks Arm 0: participant perform the same tasks without the custom-made upper limb exosuit and hand exoskeleton.
Intervention Type
Device
Intervention Name(s)
Custom-made upper limb exosuit and hand exoskeleton
Intervention Description
Participants go through 3 90-min sessions in a clinic setting and perform a series of functional tasks adapted from motor activity log and bilateral upper limb tasks with and without the device.
Primary Outcome Measure Information:
Title
Assessment of the elbow module by self-reported evaluation via questionnaire
Description
Patient self-reported outcome of the ease of use, ranked from 1 to 5, 5 being the easiest and 1 being the least easy.
Time Frame
End of the 3rd session, median duration of 5 days from baseline
Title
Assessment of the hand module by self-reported evaluation via questionnaire
Description
Patient self-reported outcome of the ease of use, ranked from 1 to 5, 5 being the easiest and 1 being the least easy.
Time Frame
End of the 3rd session, median duration of 5 days from baseline
Title
Successful completion of tasks (without intervention)
Description
The success of the tasks without the assistance of the exoskeletons was evaluated by the clinician.
Time Frame
At 2nd session, median time of 2 days from baseline
Title
Successful completion of tasks (with intervention)
Description
The success of the tasks with the assistance of the exoskeletons was evaluated by the clinician.
Time Frame
At 3rd session, median time of 5 days from baseline
Secondary Outcome Measure Information:
Title
Upper limb angular trajectory (without intervention)
Description
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.
Time Frame
Average over the 2nd session, median time of 2 days from baseline
Title
Upper limb angular trajectory (with intervention)
Description
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.
Time Frame
Average over the 3rd session, median time of 5 days from baseline
Title
Muscular synergies (without intervention)
Description
The muscular synergies of the users while not wearing the exoskeletons were measured by calculating Pearson's correlation coefficient between muscles.
Time Frame
Average over the 2nd session, median time of 2 days from baseline
Title
Muscular synergies (with intervention)
Description
The muscular synergies of the users while wearing the exoskeletons were measured by calculating Pearson's correlation coefficient between muscles.
Time Frame
Average over the 3rd session, median time of 5 days from baseline
Title
Muscular effort (without intervention)
Description
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.
Time Frame
Average over the 2nd session, median time of 2 days from baseline
Title
Muscular effort (with intervention)
Description
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.
Time Frame
Average over the 3rd session, median time of 5 days from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore

12. IPD Sharing Statement

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Upper Limb Exosuit for Clinic Assistance

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