An interventional study of SaeboGlove therapy and Usual care in Stroke, sponsored by NHS Greater Glasgow and Clyde. Suspended at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-15.
Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Treatment
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.
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.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 110 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
New clinical stroke diagnosis with:
i) Severe hand impairment (FMUE hand sub-section ≤7) and ii) Severe upper limb disability (ARAT ≤28)
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
Exclusion Criteria:
Use for 6 weeks - given an individualised self-management training programme involving repetitive grasping and releasing movements.
Device: SaeboGlove therapy
Usual NHS rehabilitation care based on National Clinical Guidelines for 6 weeks + 2 study visits and one study phone call
Behavioral: Usual care
An individualised self-management training programme involving repetitive grasping and releasing movements over 6 weeks.
6-weeks of usual NHS care
Upper limb function
Change in Upper limb function measured by the Action Research Arm Test
Time frame: Time 0 to 6 weeks
Upper limb impairment
Change in upper limb impairment as measured by Fugl-Meyer Upper Extremity (FMUE)
Time frame: 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
Time frame: Time 0 to 6 weeks
Perceived habitual functional upper limb use
Change in Motor Activity Log (MAL)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Time 0 to 6 weeks
This study is suspended, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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NHS Greater Glasgow and Clyde