The SaeboGlove Evaluation Trial

Not Applicable

• Conditions: Vascular Diseases; Stroke; Central Nervous System Diseases; Cerebral Vascular Disorder; Brain Diseases; Nervous System Diseases; Cardiovascular Diseases
• Interventions: Device: SaeboGlove

• Registration Number: NCT03036033
• Lead Sponsor: NHS Greater Glasgow and Clyde

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.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01-26
• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-01-27
• Last Update Submitted: 2017-01-27
• Study First Posted: 2017-01-30
• Last Update Posted: 2017-01-30
• Primary Completion: 2017-05-25
• Study Completion: 2017-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of sessions performed using the SaeboGlove	One month	Feasibility

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Queen Elizabeth University Hospital; 🇬🇧 Glasgow, United Kingdom