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

NCT ID: NCT04007315

Last Updated: 2020-05-15

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-21
• Study Completion Date: 2022-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SaeboGlove Therapy + usual care

Use for 6 weeks - given an individualised self-management training programme involving repetitive grasping and releasing movements.

Group Type: EXPERIMENTAL

SaeboGlove therapy

Intervention Type: DEVICE

An individualised self-management training programme involving repetitive grasping and releasing movements over 6 weeks.

Usual care

Usual NHS rehabilitation care based on National Clinical Guidelines for 6 weeks + 2 study visits and one study phone call

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

6-weeks of usual NHS care

Interventions

SaeboGlove therapy

An individualised self-management training programme involving repetitive grasping and releasing movements over 6 weeks.

Intervention Type: DEVICE

Usual care

6-weeks of usual NHS care

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Capacity to consent to study participation
• Aged ≥18 years
• New clinical stroke diagnosis with:

i) Severe hand impairment (FMUE hand sub-section ≤7) and ii) Severe upper limb disability (ARAT ≤28)

• >1 week post stroke
• Identified during stroke index admission with consent, baseline assessment and randomisation occurring as an inpatient or within 2 weeks of discharge home
• Considered eligible to use a SaeboGlove at consent/baseline assessment:

i) Reduced active range of finger extension with wrist held passively in full extension at consent/baseline ii) At least 5° passive wrist extension with fingers held passively in full extension iii) Nil to minimal digital contractures (5-10° accommodated) iv) Some initiation of gross active finger flexion v) Modified Ashworth Score ≤2

• Considered able to learn to don/doff a SaeboGlove +/- help of willing carer
• Considered able to engage in independent rehabilitation +/- help of willing carer
• Considered able to comply with the requirements of the protocol, including questionnaires

Exclusion Criteria

• Swelling of the paretic hand considered severe enough to cause discomfort when glove is worn
• Other significant upper limb impairment e.g. fixed contracture, fracture, frozen shoulder, severe arthritis, amputation
• Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. registered blind or terminal illness
• Participant in other intervention trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesse Dawson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

NHS Lothian

Edinburgh, , United Kingdom

NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

NHS Lanarkshire

Hamilton, , United Kingdom

Countries

United Kingdom

Other Identifiers

GN18ST520

Identifier Type: -

Identifier Source: org_study_id