Clinical trial NCT04007315: SaeboGlove Therapy for Severe Upper Limb Disability and Severe Hand Impairment After Stroke
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stroke
Keywords: rehabilitation
hand
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2019-07-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic, multicentre, parallel-group, randomised controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Upper limb function
timeFrame: Time 0 to 6 weeks
Secondary outcomes:
measure: Upper limb impairment
timeFrame: Time 0 to 6 weeks
measure: Upper limb pain intensity
timeFrame: Time 0 to 6 weeks
measure: Perceived habitual functional upper limb use
timeFrame: Time 0 to 6 weeks
measure: Activities of daily living
timeFrame: Time 0 to 6 weeks
measure: Quality of life - stroke
timeFrame: Time 0 to 6 weeks
measure: Quality of life - generic
timeFrame: Time 0 to 6 weeks
measure: Disability
timeFrame: Time 0 to 6 weeks
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Hamilton
country: United Kingdom
facility: NHS Lanarkshire
Study officials:
affiliation: University of Glasgow
name: Jesse Dawson, MD
role: PRINCIPAL_INVESTIGATOR
References: