NCT04007315

SaeboGlove Therapy for Severe Upper Limb Disability and Severe Hand Impairment After Stroke

SaeboGlove Therapy for Severe Upper Limb Disability and Severe Hand Impairment After Stroke (SUSHI): A Pragmatic, Multicentre, Parallel-group, Randomised Controlled Trial With Blinded Outcome Assessment and Process Evaluation

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will aim to determine whether 6-weeks of using a SaeboGlove independently (with or without help from a carer) improves upper limb function (measured using the Action Research Arm Test score) in comparison to usual care alone in people with reduced active finger extension, severe upper limb disability and severe hand impairment after recent stroke.

Detailed description

Severe arm and hand weakness causes disability and reduces quality of life after stroke. Recovery is best when people practice high numbers of movements based on everyday function such as reaching and grasping. People with severe weakness are often given treatments known to lack benefit and are frequently excluded from arm rehabilitation trials. This is because they don't have enough movement and often can't open their hand enough to carry out functional based therapy. This will be limiting recovery for those who need it most. A clinical trial is proposed of a new rehabilitation device called a SaeboGlove. It is worn on the weak hand to assist the hand to open. It can help people to grasp and release objects such as cutlery, clothes or a hairbrush during everyday activities, even when weakness is severe. This means it may enable people with severe weakness to practice beneficial movements based on everyday functional tasks and may increase their chance of a better recovery. In this study people with severe hand and arm weakness early after stroke will receive 6-weeks of usual National Health Service (NHS) care or 6-weeks of usual NHS care with additional self-directed SaeboGlove therapy. Carers or hospital staff can help participants receiving SaeboGlove therapy. Participants who do not receive SaeboGlove therapy initially will be offered it after the trial ends. This study will assess hand and arm movement and function, and quality of life at the start of the study, and 6-weeks and 14-week later. Participant, carer and clinician views and additional costs of SaeboGlove therapy will be assessed. A SaeboGlove therapy resource that stroke survivors could use independently after discharge from NHS stroke services will also be created.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	SaeboGlove therapy	An individualised self-management training programme involving repetitive grasping and releasing movements over 6 weeks.
BEHAVIORAL	Usual care	6-weeks of usual NHS care

Timeline

• Start date: 2019-11-21
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2019-07-05
• Last updated: 2020-05-15

Locations

3 sites across 1 country: United Kingdom