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The SaeboGlove Evaluation Trial (T-SET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03036033
Recruitment Status : Unknown
Verified January 2017 by Dr Jesse Dawson, NHS Greater Glasgow and Clyde.
Recruitment status was:  Recruiting
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
Dr Jesse Dawson, NHS Greater Glasgow and Clyde

Brief Summary:
This study evaluates the safety, feasibility and usability of a SaeboGlove rehabilitation device in the treatment of patients who have reduced ability to open their hand due to weakness after an acute stroke.

Condition or disease Intervention/treatment Phase
Stroke Cerebral Vascular Disorder Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Device: SaeboGlove Not Applicable

Detailed Description:
The SaeboGlove is a new rehabilitation aid that can be used in people with hand weakness after a neurological injury. It assists the hand to open, which is crucial for people to grasp, and release everyday objects. It may improve function by doing this but may also help people with severe weakness take part more fully in therapy sessions. This glove is already marketed and is being used in some NHS sites. This trial will assess how it could be used in NHS practice in acute stroke patients and will develop a plan to implement this.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single group, open feasibility study of use of a CE marked and available device.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: The SaeboGlove Evaluation Trial in Stroke
Actual Study Start Date : January 26, 2017
Estimated Primary Completion Date : May 25, 2017
Estimated Study Completion Date : July 25, 2017

Arm Intervention/treatment
Experimental: SaeboGlove Therapy
All participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program.
Device: SaeboGlove
All participants are given a Saebo glove to use during their stroke recovery.




Primary Outcome Measures :
  1. Number of sessions performed using the SaeboGlove [ Time Frame: One month ]
    Feasibility


Secondary Outcome Measures :
  1. Therapy Intensity [ Time Frame: Cumulative over one month ]
    Number of movement repetitions performed using the SaeboGlove

  2. Participant, Carer and Therapist Usability and Training Questionnaire [ Time Frame: One month ]
    Bespoke questionnaire

  3. Box and Block Test [ Time Frame: One month ]
    Measure to assess gross dexterity

  4. Action Research Arm Test (ARAT) [ Time Frame: One month ]
    Measure to assess arm function

  5. Motor Activity Log (MAL) [ Time Frame: One month ]
    Interview intended to examine how much and how well the participant uses arm

  6. Number of adverse events related to using the SaeboGlove [ Time Frame: One month ]
    Safety



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to consent
  2. Aged ≥18 years
  3. Diagnosis of stroke occurring ≤30 days ago
  4. Reduced active range of movement wrist and / or finger extension
  5. Modified ashworth score at wrist and fingers ≤ 2
  6. Some initiation of gross active finger flexion
  7. At least 10 degrees passive range of motion wrist extension
  8. Considered able to learn to don / doff a SaeboGlove +/- help of willing carer
  9. Ability to engage in some independent rehabilitation +/- help of willing carer
  10. Considered able to comply with the requirements of protocol?

Exclusion Criteria:

  1. Presence of >5-10 degrees digital contractures
  2. Presence of other upper limb impairment that would influence participation (e.g. fixed contracture, frozen shoulder, severe arthritis or upper limb pain)
  3. Presence of other conditions likely to influence participation (e.g. medically unstable, registered blind, terminal cancer, severe mood, cognitive or language issues)
  4. Participating in another stroke rehabilitation trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036033


Contacts
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Contact: Jen Alexander 0141 451 5870 ext 85870 jen.alexander@ggc.scot.nhs.uk
Contact: Dr Jesse Dawson 0141 451 5868 ext 85868 Jesse.Dawson@glasgow.ac.uk

Locations
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United Kingdom
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Jen Alexander    0141 451 5870 ext 85870    jen.alexander@ggc.scot.nhs.uk   
Contact: Dr Jesse Dawson    0141 451 5868 ext 85868    Jesse.Dawson@glasgow.ac.uk   
Sub-Investigator: Elizabeth Colquhoun         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Principal Investigator: Dr Jesse Dawson University of Glasgow

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Responsible Party: Dr Jesse Dawson, Clinical Reader, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT03036033     History of Changes
Other Study ID Numbers: GN16ST162
Res16/A169 ( Other Grant/Funding Number: CHSS )
16/NS/0112 ( Other Identifier: North of Scotland Research Ethics Service )
207595 ( Other Identifier: Integrated Research Application System )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Brain Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Nervous System Diseases