The SaeboGlove Evaluation Trial (T-SET)

The SaeboGlove Evaluation Trial in Stroke

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Vascular Diseases; Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Vascular Disorder
• Intervention / Treatment: Device: SaeboGlove

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Recruiting
    • Queen Elizabeth University Hospital
    • Contact: Jen Alexander; Phone Number: 85870 0141 451 5870; Email: jen.alexander@ggc.scot.nhs.uk
    • Contact: Dr Jesse Dawson; Phone Number: 85868 0141 451 5868; Email: Jesse.Dawson@glasgow.ac.uk
    • Sub-Investigator: Elizabeth Colquhoun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow
• Investigators: Principal Investigator: Dr Jesse Dawson, University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2017
• Primary Completion (Anticipated): May 25, 2017
• Study Completion (Anticipated): July 25, 2017

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 27, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Brain Diseases; Cerebrovascular Disorders; Central Nervous System Diseases
• Other Study ID Numbers: GN16ST162; Res16/A169 (Other Grant/Funding Number: CHSS); 16/NS/0112 (Other Identifier: North of Scotland Research Ethics Service); 207595 (Other Identifier: Integrated Research Application System)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No