Lycra Orthosis as Therapy for the Upper Limb After Stroke

Summary

Stroke is the major cause of complex adult disability in the UK. Upper limb impairment contributes to disability and fewer than 15% of survivors regain full arm and hand function by 6 months. Consequently, many stroke survivors have difficulties with activities of daily living where good upper limb and hand function is required. Upper limb impairment also predicts quality of life and independent functioning after stroke. It is therefore vital that effective therapeutic interventions to improve upper limb recovery are found.

Various therapeutic interventions to improve arm recovery after stroke have been proposed, however although effective in some circumstances, many have been proven as unacceptable and unfeasible in usual rehabilitation practice. The aim of this study is to evaluate the acceptability and feasibility of Dynamic Lycra Orthoses (DLO), as an adjunct to usual UL rehabilitation and to examine the magnitude, direction and variability of any effects on upper limb impairment and functioning.

This inexpensive, commercially available, CE marked, tailor-made lycra sleeve garment is worn for up to 8 hours a day and during rehabilitation therapy. The DLO has not been extensively studies in stroke rehabilitation, but existing evidence suggests that the garment may enhance sensory feedback and correct upper limb movement and positioning, facilitating conditions for recovery without the need for direct therapist supervision. It may therefore augment the effects of standard dose of Occupational Therapy and Physiotherapy, and self-directed practice.

This is a feasibility, randomised, controlled trial. Using 2:1 randomisation, We will recruit and randomise 60 participants with mild, moderate and severe UL impairment who have been admitted to Ninewells Hospital or Perth Royal Infirmary, Tayside, Scotland with a stroke affecting the upper limb to receive usual care or usual care plus the DLO. The DLO will be worn daily for up to 8 hours over 8 weeks. A blinded rater will collect outcomes data examining upper limb functioning, strength, dexterity, sensation, use of the arm for daily functioning and quality of life at the end of the intervention and at follow-up eight weeks later. Data relating to duration and frequency of DLO wear, proportion of eligible participants, and those willing to be randomised, drop-outs and losses to follow-up will also be recorded to assess feasibility of a full-scale trial.

Conditions

• Stroke
• Cerebrovascular Accident

Interventions

DEVICE

Dynamic Lycra Orthosis

Dynamic lycra orthoses: made to measure fabric lycra compression gauntlets individually tailored to correct upper limb movement and positioning. Worn for eight hours per day but may be removed for therapy and washing.

OTHER

Usual Rehabilitation

Physiotherapy or Occupational Therapy delivered as routine part of rehabilitation

Sponsors & Collaborators

• Chief Scientist Office of the Scottish Government

  collaborator OTHER_GOV

• University of Dundee

  collaborator OTHER

• Glasgow Caledonian University

  lead OTHER

Principal Investigators

• Jacqui Morris, PhD · Glasgow Caledonian University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-28

Primary Completion

2017-12-30

Completion

2018-03-31

Countries

• United Kingdom

Study Locations