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The SaeboGlove Evaluation Trial (T-SET)

Primary Purpose

Stroke, Cerebral Vascular Disorder, Brain Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
SaeboGlove
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Elizabeth University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SaeboGlove Therapy

Arm Description

All participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program.

Outcomes

Primary Outcome Measures

Number of sessions performed using the SaeboGlove
Feasibility

Secondary Outcome Measures

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

Full Information

First Posted
January 26, 2017
Last Updated
January 27, 2017
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT03036033
Brief Title
The SaeboGlove Evaluation Trial
Acronym
T-SET
Official Title
The SaeboGlove Evaluation Trial in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 26, 2017 (Actual)
Primary Completion Date
May 25, 2017 (Anticipated)
Study Completion Date
July 25, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebral Vascular Disorder, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Cardiovascular Diseases

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group, open feasibility study of use of a CE marked and available device.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SaeboGlove Therapy
Arm Type
Experimental
Arm Description
All participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program.
Intervention Type
Device
Intervention Name(s)
SaeboGlove
Intervention Description
All participants are given a Saebo glove to use during their stroke recovery.
Primary Outcome Measure Information:
Title
Number of sessions performed using the SaeboGlove
Description
Feasibility
Time Frame
One month
Secondary Outcome Measure Information:
Title
Therapy Intensity
Description
Number of movement repetitions performed using the SaeboGlove
Time Frame
Cumulative over one month
Title
Participant, Carer and Therapist Usability and Training Questionnaire
Description
Bespoke questionnaire
Time Frame
One month
Title
Box and Block Test
Description
Measure to assess gross dexterity
Time Frame
One month
Title
Action Research Arm Test (ARAT)
Description
Measure to assess arm function
Time Frame
One month
Title
Motor Activity Log (MAL)
Description
Interview intended to examine how much and how well the participant uses arm
Time Frame
One month
Title
Number of adverse events related to using the SaeboGlove
Description
Safety
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jen Alexander
Phone
0141 451 5870
Ext
85870
Email
jen.alexander@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Jesse Dawson
Phone
0141 451 5868
Ext
85868
Email
Jesse.Dawson@glasgow.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Jesse Dawson
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jen Alexander
Phone
0141 451 5870
Ext
85870
Email
jen.alexander@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Dr Jesse Dawson
Phone
0141 451 5868
Ext
85868
Email
Jesse.Dawson@glasgow.ac.uk
First Name & Middle Initial & Last Name & Degree
Elizabeth Colquhoun

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The SaeboGlove Evaluation Trial

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