The SaeboGlove Evaluation Trial

NHS Greater Glasgow and Clyde12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

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

Interventions

SaeboGloveDEVICE

All participants are given a Saebo glove to use during their stroke recovery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen Elizabeth University Hospital

Glasgow, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Number of sessions performed using the SaeboGlove

Feasibility

Time frame: One month

Secondary Outcomes

Therapy Intensity

Number of movement repetitions performed using the SaeboGlove

Time frame: Cumulative over one month

Participant, Carer and Therapist Usability and Training Questionnaire

Bespoke questionnaire

Time frame: One month

Box and Block Test

Measure to assess gross dexterity

Time frame: One month

Action Research Arm Test (ARAT)

Measure to assess arm function

Time frame: One month

Motor Activity Log (MAL)

Interview intended to examine how much and how well the participant uses arm

Time frame: One month

Number of adverse events related to using the SaeboGlove

Safety

Time frame: One month

Central Contacts

Jen Alexander

CONTACT

0141 451 5870 jen.alexander@ggc.scot.nhs.uk

Dr Jesse Dawson

CONTACT

0141 451 5868 Jesse.Dawson@glasgow.ac.uk

Data from ClinicalTrials.gov

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