The SaeboGlove Evaluation Trial "T-SET"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • SaeboGlove Device
    Intervention Desc: All participants are given a Saebo glove to use during their stroke recovery.
    ARM 1: Kind: Experimental
    Label: SaeboGlove Therapy
    Description: All participants will be given a SaeboGlove for a 4-week period to use along side their routine functional based training program.

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of sessions performed using the SaeboGlove One month
Secondary Therapy Intensity Cumulative over one month
Secondary Participant, Carer and Therapist Usability and Training Questionnaire One month
Secondary Box and Block Test One month
Secondary Action Research Arm Test (ARAT) One month
Secondary Motor Activity Log (MAL) One month
Secondary Number of adverse events related to using the SaeboGlove One month

Sponsors