Lycra Orthosis as Therapy for the Upper Limb After Stroke

NCT03063970 | Completed

• 1 other identifier: Glasgow Caledonian NMAHP RU
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Upper extremity; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test

  Measure of Upper Limb Activity Limitation: total score of 57 for performance of 4 summed domains: Grip, grasp, gross and pinch

  8 weeks

Secondary Outcomes (21)

• Motricity Index Upper Limb Section

  Week 8

• Motricity Index Upper Limb Section

  Week 16

• ERASMUS MC Nottingham Sensory Assessment

  Week 8

• ERASMUS MC Nottingham Sensory Assessment

  Week 16

• Nine Hole Peg Test

  Week 8

Study Arms (2)

Experimental Group

EXPERIMENTAL

Wear of the tailor made Dynamic Lycra Orthosis for up to eight hours every day for eight weeks Usual rehabilitation

Device: Dynamic Lycra Orthosis; Other: Usual Rehabilitation

Comparison Group

ACTIVE COMPARATOR

Usual rehabilitation

Other: Usual Rehabilitation

Interventions

Dynamic Lycra Orthosis DEVICE

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.

Experimental Group

Usual Rehabilitation OTHER

Physiotherapy or Occupational Therapy delivered as routine part of rehabilitation

Comparison Group; Experimental Group

Eligibility Criteria

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

You may qualify if:

• Unilateral ischaemic or haemorrhagic stroke diagnosed on CT scan or MRI. Persistent UL impairment 2-4 weeks after stroke onset indicated by a score on the Action Research Arm Test (ARAT) of between 0 and 45 (maximum score 57), indicating a persistent motor weakness with the preserved ability to make some movement with the affected arm.
• Medically stable and able to participate in usual rehabilitation activities.

You may not qualify if:

• Severe aphasia or cognitive impairment that limits participation and ability to provide informed consent.
• Previous stroke resulting in residual disability.
• Premorbid arm impairment.
• Hemiplegic shoulder pain.
• Sensitivity to lycra.
• Any other upper limb orthoses already prescribed and in use.
• Unable to provide informed consent.

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• Chief Scientist Office of the Scottish Government: collaborator
• University of Dundee: collaborator

Study Sites (2)

Ninewells Hospital

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Perth Royal Informary

Perth, Tayside, PH1 1NX, 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

• Jacqui Morris, PhD

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessor otherwise uninvolved in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility Randomised Controlled Trial

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 24, 2017
• Study Start: February 28, 2017
• Primary Completion: December 30, 2017
• Study Completion: March 31, 2018
• Last Updated: July 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)