Clinical trial NCT03036033: The SaeboGlove Evaluation Trial
Official title: The SaeboGlove Evaluation Trial in Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Cerebral Vascular Disorder
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2017-01-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group, open feasibility study of use of a CE marked and available device.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of sessions performed using the SaeboGlove
timeFrame: One month
Secondary outcomes:
measure: Therapy Intensity
timeFrame: Cumulative over one month
measure: Participant, Carer and Therapist Usability and Training Questionnaire
timeFrame: One month
measure: Box and Block Test
timeFrame: One month
measure: Action Research Arm Test (ARAT)
timeFrame: One month
measure: Motor Activity Log (MAL)
timeFrame: One month
measure: Number of adverse events related to using the SaeboGlove
timeFrame: One month
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: University of Glasgow
name: Dr Jesse Dawson
role: PRINCIPAL_INVESTIGATOR
References: