StrokeT-SETNCT03036033
The SaeboGlove Evaluation Trial
A study testing SaeboGlove in people with Stroke and Cerebral Vascular Disorder, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebral Vascular Disorder, Brain Diseases
- What is being tested?
- SaeboGlove
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jan 2017to 25 Jul 2017
- 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
- Able to consent
- Aged ≥18 years
- Diagnosis of stroke occurring ≤30 days ago
- Reduced active range of movement wrist and / or finger extension
- Modified ashworth score at wrist and fingers ≤ 2
- Some initiation of gross active finger flexion
Show all 10Show fewer
- At least 10 degrees passive range of motion wrist extension
- Considered able to learn to don / doff a SaeboGlove +/- help of willing carer
- Ability to engage in some independent rehabilitation +/- help of willing carer
- Considered able to comply with the requirements of protocol?
Who cannot join
- Presence of >5-10 degrees digital contractures
- Presence of other upper limb impairment that would influence participation (e.g. fixed contracture, frozen shoulder, severe arthritis or upper limb pain)
- Presence of other conditions likely to influence participation (e.g. medically unstable, registered blind, terminal cancer, severe mood, cognitive or language issues)
- Participating in another stroke rehabilitation trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Jen Alexander, 0141 451 5870 ext. 85870, jen.alexander@ggc.scot.nhs.uk
Dr Jesse Dawson, 0141 451 5868 ext. 85868, Jesse.Dawson@glasgow.ac.uk
About this study
Official title: The SaeboGlove Evaluation Trial in Stroke
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.
Read the 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.
- Conditions
- Stroke, Cerebral Vascular Disorder, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases
- Being tested
- SaeboGlove
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaeboGloveDevice
All participants are given a Saebo glove to use during their stroke recovery.
| Study group | Role | What they receive |
|---|---|---|
| SaeboGlove Therapy | Experimental | All participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program. Receives: Device: SaeboGlove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sessions performed using the SaeboGlove
Feasibility
Measured: One month
Secondary outcomes (6)
Therapy Intensity
Number of movement repetitions performed using the SaeboGlove
Measured: Cumulative over one month
Participant, Carer and Therapist Usability and Training Questionnaire
Bespoke questionnaire
Measured: One month
Box and Block Test
Measure to assess gross dexterity
Measured: One month
Action Research Arm Test (ARAT)
Measure to assess arm function
Measured: One month
Motor Activity Log (MAL)
Interview intended to examine how much and how well the participant uses arm
Measured: One month
Number of adverse events related to using the SaeboGlove
Safety
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start26 Jan 2017
- Primary completion25 May 2017 (estimated)
- Study completion25 Jul 2017 (estimated)
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, open feasibility study of use of a CE marked and available device.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Principal investigator, Dr Jesse Dawson, NHS Greater Glasgow and Clyde
- Investigators
- Dr Jesse Dawson, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036033
- Sponsor's protocol ID
- GN16ST162
- Other IDs
- Res16/A169, 16/NS/0112, 207595
- Acronym
- T-SET
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SaeboGlove Evaluation Trial in Stroke
- ClinicalTrials.gov ID
- NCT03036033
- Acronym / sponsor ID
- T-SET / GN16ST162
- Conditions
- Stroke, Cerebral Vascular Disorder, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 25 May 2017 (estimated)
- Study completion
- 25 Jul 2017 (estimated)
- First posted
- 30 Jan 2017 (estimated)
- 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.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, open feasibility study of use of a CE marked and available device.
| Arm | Type | Receives |
|---|---|---|
| SaeboGlove Therapy | Experimental | Device: SaeboGloveAll participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to consent
- Aged ≥18 years
- Diagnosis of stroke occurring ≤30 days ago
- Reduced active range of movement wrist and / or finger extension
- Modified ashworth score at wrist and fingers ≤ 2
Key exclusion criteria (4 listed)
- Presence of >5-10 degrees digital contractures
- Presence of other upper limb impairment that would influence participation (e.g. fixed contracture, frozen shoulder, severe arthritis or upper limb pain)
- Presence of other conditions likely to influence participation (e.g. medically unstable, registered blind, terminal cancer, severe mood, cognitive or language issues)
- Participating in another stroke rehabilitation 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 |
|---|---|---|
| SaeboGloveAll participants are given a Saebo glove to use during their stroke recovery. | Device | SaeboGlove Therapy |
Primary outcome
Number of sessions performed using the SaeboGlove
Time frame: One month
Feasibility
6 secondary outcomes
Therapy Intensity
Time frame: Cumulative over one month
Participant, Carer and Therapist Usability and Training Questionnaire
Time frame: One month
Box and Block Test
Time frame: One month
Action Research Arm Test (ARAT)
Time frame: One month
Motor Activity Log (MAL)
Time frame: One month
Number of adverse events related to using the SaeboGlove
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
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Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
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Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
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.
Dr Jesse Dawson principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaeboGlove in people with Stroke and Cerebral Vascular Disorder, run by NHS Greater Glasgow and Clyde at 1 site 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 10 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: status not confirmed, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Jen Alexander (0141 451 5870 ext. 85870, jen.alexander@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sessions performed using the SaeboGlove (time frame: One month). 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 30 Jan 2017.