The SaeboGlove Evaluation Trial (T-SET)

NHS Trust

Status: Unknown

Conditions: Stroke; Cerebral Vascular Disorder; Central Nervous System Diseases; Cardiovascular Diseases; Nervous System Diseases; Vascular Diseases; Brain Diseases

Treatments: Device: SaeboGlove

Study type: Interventional

Funder types: Other

Identifiers

NCT03036033

16/NS/0112 (Other Identifier)

207595 (Other Identifier)

GN16ST162

Res16/A169 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

SaeboGlove Therapy

Experimental group

Description:

All participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program.

Treatment:

Device: SaeboGlove