Upper Limb Exosuit for Clinic Assistance

NCT05118321 | Completed DMC

• 1 other identifier: 2018/01358
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

exoskeleton; robot; stroke; upper limb; hand; assistance

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Upper limb angular trajectory (without intervention)

  Average over the 2nd session, median time of 2 days from baseline

• Upper limb angular trajectory (with intervention)

  Average over the 3rd session, median time of 5 days from baseline

• Muscular synergies (without intervention)

  Average over the 2nd session, median time of 2 days from baseline

• Muscular synergies (with intervention)

  Average over the 3rd session, median time of 5 days from baseline

• Muscular effort (without intervention)

  Average over the 2nd session, median time of 2 days from baseline

Study Arms (1)

Refinement and Feasibility Trial

OTHER

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.

Device: Custom-made upper limb exosuit and hand exoskeleton

Interventions

Custom-made upper limb exosuit and hand exoskeleton DEVICE

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.

Refinement and Feasibility Trial

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Nanyang Technological University: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Stroke; Helping Behavior

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: November 11, 2021
• Study Start: March 23, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

SG (1)