LOTUS Study 1
Research type
Research Study
Full title
Dynamic Lycra Orthoses as an adjunct to upper limb rehabilitation after stroke: A feasibility study and trial.
IRAS ID
164117
Contact name
Jacqui Morris
Contact email
Sponsor organisation
Glasgow Caledonian University
Duration of Study in the UK
2 years, 6 months, 26 days
Research summary
The aim of this study is to , the acceptability and feasibility of Dynamic Lycra Orthoses (DLO) for evaluate as an adjunct to usual rehabilitation for arm recovery after stroke. This is a commercially available, kite marked, tailor-made lycra sleeve garment, worn for up to 8 hours a day and during rehabilitation therapy. The study will also examine magnitude, direction and variability of any effects on upper limb impairment and functioning.
Phase 1. Twenty stroke survivors will wear the garment and provide feedback about its use and perceived benefits. We will examine experiences through qualitative interviews with survivors (n=20) staff (n= 12) and carers (n=12). We will test the intervention trial protocol and identify the definitive battery of outcome measures. We will also assess time to delivery, promptness and responses to queries of the two companies that provide the orthoses and examine participant preferences of the garments to select the appropriate company for provision of garments for the feasibility trial.
Phase 2. This phase is a feasibility, randomised, controlled trial. We will randomise 60 participants who have been admitted to Ninewells Hospital or Perth Royal Infirmary with a stroke affecting the upper limb to usual care or usual care plus the DLO. The DLO will be worn daily for about 8 weeks, depending on phase 1 findings. 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, recruitment, drop-outs and losses to follow-up will also be recorded to assess feasibility of a full-scale trial. We will conduct interviews at the end of the study to evaluate trial experiences.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
15/ES/0093
Date of REC Opinion
1 Jul 2015
REC opinion
Favourable Opinion