The SaeboGlove Evaluation Trial
T-SET
4 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable stroke
Started Jan 2017
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2017
CompletedStudy Start
First participant enrolled
January 26, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2017
CompletedJanuary 30, 2017
January 1, 2017
4 months
January 26, 2017
January 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of sessions performed using the SaeboGlove
Feasibility
One month
Secondary Outcomes (6)
Therapy Intensity
Cumulative over one month
Participant, Carer and Therapist Usability and Training Questionnaire
One month
Box and Block Test
One month
Action Research Arm Test (ARAT)
One month
Motor Activity Log (MAL)
One month
- +1 more secondary outcomes
Study Arms (1)
SaeboGlove Therapy
EXPERIMENTALAll participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program.
Interventions
All participants are given a Saebo glove to use during their stroke recovery.
Eligibility Criteria
You may qualify if:
- 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?
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- University of Glasgowcollaborator
Study Sites (1)
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Jesse Dawson
University of Glasgow
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Reader
Study Record Dates
First Submitted
January 26, 2017
First Posted
January 30, 2017
Study Start
January 26, 2017
Primary Completion
May 25, 2017
Study Completion
July 25, 2017
Last Updated
January 30, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share