The SaeboGlove Evaluation Trial

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.

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.

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