SaeboGlove Therapy for Severe Upper Limb Disability and Severe Hand Impairment After Stroke (SUSHI)
Stroke
About this trial
This is an interventional treatment trial for Stroke focused on measuring rehabilitation, hand
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
Sites / Locations
- NHS Lothian
- NHS Greater Glasgow and Clyde
- NHS Lanarkshire
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
SaeboGlove Therapy + usual care
Usual care
Use for 6 weeks - given an individualised self-management training programme involving repetitive grasping and releasing movements.
Usual NHS rehabilitation care based on National Clinical Guidelines for 6 weeks + 2 study visits and one study phone call