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SaeboGlove Therapy for Severe Upper Limb Disability and Severe Hand Impairment After Stroke (SUSHI)

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ClinicalTrials.gov Identifier: NCT04007315
Recruitment Status : Suspended (COVID-19)
First Posted : July 5, 2019
Last Update Posted : May 15, 2020
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:
The study will aim to determine whether 6-weeks of using a SaeboGlove independently (with or without help from a carer) improves upper limb function (measured using the Action Research Arm Test score) in comparison to usual care alone in people with reduced active finger extension, severe upper limb disability and severe hand impairment after recent stroke.

Condition or disease Intervention/treatment Phase
Stroke Device: SaeboGlove therapy Behavioral: Usual care Not Applicable

Detailed Description:

Severe arm and hand weakness causes disability and reduces quality of life after stroke. Recovery is best when people practice high numbers of movements based on everyday function such as reaching and grasping. People with severe weakness are often given treatments known to lack benefit and are frequently excluded from arm rehabilitation trials. This is because they don't have enough movement and often can't open their hand enough to carry out functional based therapy. This will be limiting recovery for those who need it most.

A clinical trial is proposed of a new rehabilitation device called a SaeboGlove. It is worn on the weak hand to assist the hand to open. It can help people to grasp and release objects such as cutlery, clothes or a hairbrush during everyday activities, even when weakness is severe. This means it may enable people with severe weakness to practice beneficial movements based on everyday functional tasks and may increase their chance of a better recovery.

In this study people with severe hand and arm weakness early after stroke will receive 6-weeks of usual National Health Service (NHS) care or 6-weeks of usual NHS care with additional self-directed SaeboGlove therapy. Carers or hospital staff can help participants receiving SaeboGlove therapy. Participants who do not receive SaeboGlove therapy initially will be offered it after the trial ends.

This study will assess hand and arm movement and function, and quality of life at the start of the study, and 6-weeks and 14-week later. Participant, carer and clinician views and additional costs of SaeboGlove therapy will be assessed.

A SaeboGlove therapy resource that stroke survivors could use independently after discharge from NHS stroke services will also be created.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A pragmatic, multicentre, parallel-group, randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SaeboGlove Therapy for Severe Upper Limb Disability and Severe Hand Impairment After Stroke (SUSHI): A Pragmatic, Multicentre, Parallel-group, Randomised Controlled Trial With Blinded Outcome Assessment and Process Evaluation
Actual Study Start Date : November 21, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Experimental: SaeboGlove Therapy + usual care
Use for 6 weeks - given an individualised self-management training programme involving repetitive grasping and releasing movements.
Device: SaeboGlove therapy
An individualised self-management training programme involving repetitive grasping and releasing movements over 6 weeks.

Active Comparator: Usual care
Usual NHS rehabilitation care based on National Clinical Guidelines for 6 weeks + 2 study visits and one study phone call
Behavioral: Usual care
6-weeks of usual NHS care




Primary Outcome Measures :
  1. Upper limb function [ Time Frame: Time 0 to 6 weeks ]
    Change in Upper limb function measured by the Action Research Arm Test


Secondary Outcome Measures :
  1. Upper limb impairment [ Time Frame: Time 0 to 6 weeks ]
    Change in upper limb impairment as measured by Fugl-Meyer Upper Extremity (FMUE)

  2. Upper limb pain intensity [ Time Frame: Time 0 to 6 weeks ]
    Change in score on Visual Analogue Scale (VAS): measures pain intensity on an 11-point scale displayed on a 10 cm horizontal line, ranging from 0 ("No Pain") to 10 ("Unbearable Pain"), higher scores indicate greater pain intensity

  3. Perceived habitual functional upper limb use [ Time Frame: Time 0 to 6 weeks ]
    Change in Motor Activity Log (MAL)

  4. Activities of daily living [ Time Frame: Time 0 to 6 weeks ]
    Change in Barthel Index (BI) score: measures performance in activities of daily living, includes 10 items of activities of daily living (feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing). Items are rated in terms of whether individuals can perform activities independently, with some assistance, or are dependent. Scores for each item vary between 0-1, 0-2 or 0-3 with the overall score ranging from 0-20 and the highest number being the best performance

  5. Quality of life - stroke [ Time Frame: Time 0 to 6 weeks ]
    Change in score on Stroke Impact Scale (SIS) (version 3.0): measures quality of life after stroke. It includes 59 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function). The SIS uses a 5-point Likert Scale. Summative scores for each domain range from 0-100. Total scores range from 0 to 800. A higher score reflects better function.

  6. Quality of life - generic [ Time Frame: Time 0 to 6 weeks ]
    Change in score on Equol 5 dimensions (5D), 5 levels (5L) (EQ-5D-5L): a descriptive system measuring quality of life over five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has five response levels (1-5, with 1 being the best outcome); and the responses to 5 dimensions can be combined to provide a 5 digit profile describing the respondent's health state with a single index value. An EQ-5D-5L index score of 1 represents full health.

  7. Disability [ Time Frame: Time 0 to 6 weeks ]
    Change in score on Modified rankin scale (mRS): measures degree of new disability or dependence after stroke, with a range of 0 (no new symptoms at all) to 5 (severe disability). Higher scores reflect greater disability.



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:

  • Capacity to consent to study participation
  • Aged ≥18 years
  • New clinical stroke diagnosis with:

    i) Severe hand impairment (FMUE hand sub-section ≤7) and ii) Severe upper limb disability (ARAT ≤28)

  • >1 week post stroke
  • Identified during stroke index admission with consent, baseline assessment and randomisation occurring as an inpatient or within 2 weeks of discharge home
  • Considered eligible to use a SaeboGlove at consent/baseline assessment:

    i) Reduced active range of finger extension with wrist held passively in full extension at consent/baseline ii) At least 5° passive wrist extension with fingers held passively in full extension iii) Nil to minimal digital contractures (5-10° accommodated) iv) Some initiation of gross active finger flexion v) Modified Ashworth Score ≤2

  • Considered able to learn to don/doff a SaeboGlove +/- help of willing carer
  • Considered able to engage in independent rehabilitation +/- help of willing carer
  • Considered able to comply with the requirements of the protocol, including questionnaires

Exclusion Criteria:

  • Swelling of the paretic hand considered severe enough to cause discomfort when glove is worn
  • Other significant upper limb impairment e.g. fixed contracture, fracture, frozen shoulder, severe arthritis, amputation
  • Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. registered blind or terminal illness
  • Participant in other intervention 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): NCT04007315


Locations
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United Kingdom
NHS Lothian
Edinburgh, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
NHS Lanarkshire
Hamilton, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Principal Investigator: Jesse Dawson, MD University of Glasgow
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT04007315    
Other Study ID Numbers: GN18ST520
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NHS Greater Glasgow and Clyde:
rehabilitation
hand
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases