The SaeboGlove Evaluation Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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The SaeboGlove Evaluation Trial in Stroke

Conditions
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Stroke, Cerebral Vascular Disorder, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Device: SaeboGlove


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to consent Aged ≥18 years Diagnosis of stroke occurring ≤30 days ago Reduced active range of movement wrist and / or finger extension Modified ashworth score at wrist and fingers ≤ 2 Some initiation of gross active finger flexion At least 10 degrees passive range of motion wrist extension Considered able to learn to don / doff a SaeboGlove +/- help of willing carer Ability to engage in some independent rehabilitation +/- help of willing carer Considered able to comply with the requirements of protocol? Exclusion Criteria: Presence of >5-10 degrees digital contractures Presence of other upper limb impairment that would influence participation (e.g. fixed contracture, frozen shoulder, severe arthritis or upper limb pain) Presence of other conditions likely to influence participation (e.g. medically unstable, registered blind, terminal cancer, severe mood, cognitive or language issues) Participating in another stroke rehabilitation trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Single group, open feasibility study of use of a CE marked and available device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SaeboGlove Therapy<br>All participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program. | Device: SaeboGlove<br>* All participants are given a Saebo glove to use during their stroke recovery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sessions performed using the SaeboGlove | Feasibility | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy Intensity | Number of movement repetitions performed using the SaeboGlove | Cumulative over one month | 
| Participant, Carer and Therapist Usability and Training Questionnaire | Bespoke questionnaire | One month | 
| Box and Block Test | Measure to assess gross dexterity | One month | 
| Action Research Arm Test (ARAT) | Measure to assess arm function | One month | 
| Motor Activity Log (MAL) | Interview intended to examine how much and how well the participant uses arm | One month | 
| Number of adverse events related to using the SaeboGlove | Safety | One month |