The SaeboGlove Evaluation Trial

Stroke Clinical Trial

— T-SET  

Official title:

The SaeboGlove Evaluation Trial in Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03036033
• Other study ID #: GN16ST162
• Secondary ID: Res16/A16916/NS/
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2017
• Last updated: January 27, 2017
• Start date: January 26, 2017
• Est. completion date: July 25, 2017

Study information

• Verified date: January 2017
• Source: NHS Greater Glasgow and Clyde
• Contact: Jen Alexander
• Phone: 0141 451 5870
• Email: jen.alexander[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 25, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Cardiovascular Diseases
• Central Nervous System Diseases
• Cerebral Vascular Disorder
• Cerebrovascular Disorders
• Nervous System Diseases
• Stroke
• Vascular Diseases

Intervention

Device:
• SaeboGlove
All participants are given a Saebo glove to use during their stroke recovery.

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth University Hospital	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

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