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

NCT04007315 | Suspended

• 1 other identifier: GN18ST520
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

rehabilitation; hand

Outcome Measures

Primary Outcomes (1)

• Upper limb function

  Change in Upper limb function measured by the Action Research Arm Test

  Time 0 to 6 weeks

Secondary Outcomes (7)

• Upper limb impairment

  Time 0 to 6 weeks

• Upper limb pain intensity

  Time 0 to 6 weeks

• Perceived habitual functional upper limb use

  Time 0 to 6 weeks

• Activities of daily living

  Time 0 to 6 weeks

• Quality of life - stroke

  Time 0 to 6 weeks

Study Arms (2)

SaeboGlove Therapy + usual care

EXPERIMENTAL

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

Device: SaeboGlove therapy

Usual care

ACTIVE COMPARATOR

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

Behavioral: Usual care

Interventions

SaeboGlove therapy DEVICE

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

SaeboGlove Therapy + usual care

Usual care BEHAVIORAL

6-weeks of usual NHS care

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (3)

NHS Lothian

Edinburgh, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

NHS Lanarkshire

Hamilton, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jesse Dawson, MD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic, multicentre, parallel-group, randomised controlled trial

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: November 21, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 15, 2020

Record last verified: 2020-05

Locations

GB (3)