Brain Diseases, Cardiovascular Diseases, Central Nervous System Diseases, Cerebral Vascular Disorder, Nervous System Diseases, Stroke, Vascular Diseases
Conditions
Brief 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.
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.
Interventions
DEVICESaeboGlove
All participants are given a Saebo glove to use during their stroke recovery.
Sponsors
University of Glasgow
NHS Greater Glasgow and Clyde
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Single group, open feasibility study of use of a CE marked and available device.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to consent 2. Aged ≥18 years 3. Diagnosis of stroke occurring ≤30 days ago 4. Reduced active range of movement wrist and / or finger extension 5. Modified ashworth score at wrist and fingers ≤ 2 6. Some initiation of gross active finger flexion 7. At least 10 degrees passive range of motion wrist extension 8. Considered able to learn to don / doff a SaeboGlove +/- help of willing carer 9. Ability to engage in some independent rehabilitation +/- help of willing carer 10. Considered able to comply with the requirements of protocol?
Exclusion criteria
1. Presence of \>5-10 degrees digital contractures 2. Presence of other upper limb impairment that would influence participation (e.g. fixed contracture, frozen shoulder, severe arthritis or upper limb pain) 3. Presence of other conditions likely to influence participation (e.g. medically unstable, registered blind, terminal cancer, severe mood, cognitive or language issues) 4. Participating in another stroke rehabilitation trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of sessions performed using the SaeboGlove | One month | Feasibility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant, Carer and Therapist Usability and Training Questionnaire | One month | Bespoke questionnaire |
| Box and Block Test | One month | Measure to assess gross dexterity |
| Therapy Intensity | Cumulative over one month | Number of movement repetitions performed using the SaeboGlove |
| Motor Activity Log (MAL) | One month | Interview intended to examine how much and how well the participant uses arm |
| Number of adverse events related to using the SaeboGlove | One month | Safety |
| Action Research Arm Test (ARAT) | One month | Measure to assess arm function |
Countries
United Kingdom
Contacts
Primary ContactJen Alexander
Backup ContactDr Jesse Dawson
Outcome results
None listed