StrokeSUSHINCT04007315
SaeboGlove Therapy for Severe Upper Limb Disability and Severe Hand Impairment After Stroke
A study testing SaeboGlove therapy in people with Stroke, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- SaeboGlove therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 21 Nov 2019to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capacity to consent to study participation
- Aged ≥18 years
- New clinical stroke diagnosis with:
- 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
Show all 11Show fewer
- Considered eligible to use a SaeboGlove at consent/baseline assessment:
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
NHS Lothian
Edinburgh
NHS Greater Glasgow and Clyde
Glasgow
NHS Lanarkshire
Hamilton
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- SaeboGlove therapy, Usual care
- Keywords
- rehabilitation, hand
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaeboGlove therapyDevice
An individualised self-management training programme involving repetitive grasping and releasing movements over 6 weeks.
Usual careBehavioural
6-weeks of usual NHS care
| Study group | Role | What they receive |
|---|---|---|
| SaeboGlove Therapy + usual care | Experimental | Use for 6 weeks - given an individualised self-management training programme involving repetitive grasping and releasing movements. Receives: Device: SaeboGlove therapy |
| Usual care | Active comparator | Usual NHS rehabilitation care based on National Clinical Guidelines for 6 weeks + 2 study visits and one study phone call Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb function
Change in Upper limb function measured by the Action Research Arm Test
Measured: Time 0 to 6 weeks
Secondary outcomes (7)
Upper limb impairment
Change in upper limb impairment as measured by Fugl-Meyer Upper Extremity (FMUE)
Measured: Time 0 to 6 weeks
Upper limb pain intensity
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
Measured: Time 0 to 6 weeks
Perceived habitual functional upper limb use
Change in Motor Activity Log (MAL)
Measured: Time 0 to 6 weeks
Activities of daily living
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
Measured: Time 0 to 6 weeks
Quality of life - stroke
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.
Measured: Time 0 to 6 weeks
Quality of life - generic
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.
Measured: Time 0 to 6 weeks
Disability
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.
Measured: Time 0 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start21 Nov 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pragmatic, multicentre, parallel-group, randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Jesse Dawson, MD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007315
- Sponsor's protocol ID
- GN18ST520
- Acronym
- SUSHI
- Status last verified
- May 2020
- First submitted
- 1 Jul 2019
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04007315
- Acronym / sponsor ID
- SUSHI / GN18ST520
- Conditions
- Stroke
- Keywords
- rehabilitation, hand
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID-19
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A pragmatic, multicentre, parallel-group, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| SaeboGlove Therapy + usual care | Experimental | Device: SaeboGlove therapyUse for 6 weeks - given an individualised self-management training programme involving repetitive grasping and releasing movements. |
| Usual care | Active comparator | Behavioral: Usual careUsual NHS rehabilitation care based on National Clinical Guidelines for 6 weeks + 2 study visits and one study phone call |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Capacity to consent to study participation
- Aged ≥18 years
- New clinical stroke diagnosis with:
- >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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaeboGlove therapyAn individualised self-management training programme involving repetitive grasping and releasing movements over 6 weeks. | Device | SaeboGlove Therapy + usual care |
| Usual care6-weeks of usual NHS care | Behavioural | Usual care |
Primary outcome
Upper limb function
Time frame: Time 0 to 6 weeks
Change in Upper limb function measured by the Action Research Arm Test
7 secondary outcomes
Upper limb impairment
Time frame: Time 0 to 6 weeks
Upper limb pain intensity
Time frame: Time 0 to 6 weeks
Perceived habitual functional upper limb use
Time frame: Time 0 to 6 weeks
Activities of daily living
Time frame: Time 0 to 6 weeks
Quality of life - stroke
Time frame: Time 0 to 6 weeks
Quality of life - generic
Time frame: Time 0 to 6 weeks
Disability
Time frame: Time 0 to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesse Dawson, MD principal investigator
University of Glasgow
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaeboGlove therapy in people with Stroke, run by NHS Greater Glasgow and Clyde at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper limb function (time frame: Time 0 to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.