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Lycra Orthosis as Therapy for the Upper Limb After Stroke (LOTUS)

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ClinicalTrials.gov Identifier: NCT03063970
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : March 1, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Stroke Cerebrovascular Accident Device: Dynamic Lycra Orthosis Other: Usual Rehabilitation

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Feasibility Randomised Controlled Trial
Masking: Single (Outcomes Assessor)
Masking Description: Blinded assessor otherwise uninvolved in the study.
Primary Purpose: Treatment
Official Title: Dynamic Lycra Orthosis as an Adjunct to Upper Limb Rehabilitation After Stroke: A Randomised Controlled Feasibility Trial
Actual Study Start Date : January 13, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Experimental Group
Wear of the tailor made Dynamic Lycra Orthosis for up to eight hours every day for eight weeks Usual rehabilitation
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
Active Comparator: Comparison Group
Usual rehabilitation
Other: Usual Rehabilitation
Physiotherapy or Occupational Therapy delivered as routine part of rehabilitation


Outcome Measures

Primary Outcome Measures :
  1. Action Research Arm Test [ Time Frame: 8 weeks ]
    Measure of Upper Limb Activity Limitation: total score of 57 for performance of 4 summed domains: Grip, grasp, gross and pinch


Secondary Outcome Measures :
  1. Motricity Index Upper Limb Section [ Time Frame: Week 8 ]

    Measure of Upper Limb Motor Impairment & Strength.

    Resistance to pinch, elbow flexion and shoulder abduction are scored to a maximum score of 33. Section scores are summed to a total of 100.

    0 = No movement.

    9 = Palpable contraction in muscle but no movement.

    14 = Movement seen but not full range/ not against gravity.

    19 = Full range against gravity, not against resistance.

    25 = Movement against resistance but weaker than other side.

    33 = Normal power.


  2. Motricity Index Upper Limb Section [ Time Frame: Week 16 ]

    Measure of Upper Limb Motor Impairment & Strength.

    Resistance to Pinch, elbow flexion and shoulder abduction are scored to a maximum score of 33. Section scores are summed to a total of 100

    0 = No movement.

    9 = Palpable contraction in muscle but no movement.

    14 = Movement seen but not full range/ not against gravity.

    19 = Full range against gravity, not against resistance.

    25 = Movement against resistance but weaker than other side.

    33 = Normal power.


  3. ERASMUS MC Nottingham Sensory Assessment [ Time Frame: Week 8 ]

    Light Touch and Kinaesthetic Sense are assessed for the fingers, forearm and hand. Domains are scored for sensation:

    0 = absent, 1 = impaired, 2 = normal

    Scores for light touch and kinaesthetic sense are summed to a total score of 8 for each domain.


  4. ERASMUS MC Nottingham Sensory Assessment [ Time Frame: Week 16 ]

    Light Touch and Kinaesthetic Sense are assessed for the fingers, forearm and hand. Domains are scored for sensation:

    0 = absent, 1 = impaired, 2 = normal

    Scores for light touch and kinaesthetic sense are summed to a total score of 8 for each domain


  5. Nine Hole Peg Test [ Time Frame: Week 8 ]
    Timed Upper Limb Dexterity Test. Nine pegs are placed in nine holes and removed. Scored by time (seconds) taken to place and remove pegs

  6. Nine Hole Peg Test [ Time Frame: Week 16 ]
    Timed Upper Limb Dexterity Test. Nine pegs are placed in nine holes and removed. Scored by time (seconds) taken to place and remove pegs

  7. Grip Strength Dynamometry [ Time Frame: Week 8 ]

    Grip Strength Measurement using Jamar Dynamometer

    Grip strength scored in Kg


  8. Grip Strength Dynamometry [ Time Frame: Week 16 ]

    Grip Strength Measurement using Jamar Dynamometer

    Grip strength scored in Kg


  9. Motor Assessment Log 14 [ Time Frame: 8 Weeks ]

    Questionnaire assessing how much and how well a participant uses their stroke affected arm for everyday tasks.

    14 items are scored between 0 and 5 by the participant to indicate how well and how often they perform the task


  10. Motor Assessment Log 14 [ Time Frame: 16 weeks ]

    Questionnaire assessing how much and how well a participant uses their stroke affected arm for everyday tasks.

    14 items are scored between 0 and 5 by the participant to indicate how well and how often they perform the task


  11. Tardieu Scale [ Time Frame: 8 weeks ]

    Assessment of Upper Limb Muscle Tone that takes account of passive movement resistance at slow and fast speed. Scores recorded for angle of muscle reaction at fast and slow stretch and for quality of movement:

    0 = No resistance, 1 = slight resistance, 2 = clear catch at precise angle, 4 = fatigable clonus, 5 = infatigable clonus


  12. Tardieu Scale [ Time Frame: 16 weeks ]

    Assessment of Upper Limb Muscle Tone that takes account of passive movement resistance at slow and fast speed. Scores recorded for angle of muscle reaction at fast and slow stretch and for quality of movement:

    0 = No resistance, 1 = slight resistance, 2 = clear catch at precise angle, 4 = fatigable clonus, 5 = infatigable clonus


  13. Unilateral inattention and extinction [ Time Frame: 8 weeks ]

    NIH Stroke Scale item 11, test of inattention and extinction: Total possible score = 4, maximum of 2 each for extinction and inattention:

    0 = No abnormality, 1 = Visual, tactile, auditory, spatial, or personal inattention or extinction to bilateral simultaneous stimulation in one of the sensory modalities, 2 = Profound hemi-inattention or hemi-inattention to more than one modality.


  14. Unilateral inattention and extinction [ Time Frame: 16 weeks ]

    NIH Stroke Scale item 11, test of inattention and extinction: Total possible score = 4, maximum of 2 each for extinction and inattention:

    0 = No abnormality, 1 = Visual, tactile, auditory, spatial, or personal inattention or extinction to bilateral simultaneous stimulation in one of the sensory modalities, 2 = Profound hemi-inattention or hemi-inattention to more than one modality.


  15. EQ5D [ Time Frame: 8 weeks ]
    Quality of Life Assessment: Score maximum of 5, indicating fewer problems for domains of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ5D VAS provides overall assessment of health rated in scale between 0 and 100 where 100 is best health

  16. EQ5D [ Time Frame: 16 weeks ]
    Quality of Life Assessment: Score maximum of 5, indicating fewer problems for domains of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ5D VAS provides overall assessment of health rated in scale between 0 and 100 where 100 is best health

  17. Modified Barthel Index [ Time Frame: 8 weeks ]
    Activities of Daily Living: summed score of independence scored across 10 domains of activities of daily living. Maximum Score 100

  18. Modified Barthel Index [ Time Frame: 16 weeks ]
    Activities of Daily Living: summed score of independence scored across 10 domains of activities of daily living. Maximum Score 100

  19. Action Research Arm Test [ Time Frame: 16 Weeks ]
    Measure of Upper Limb Activity Limitation: total score of 57 for performance of 4 summed domains: Grip, grasp, gross and pinch

  20. Star cancellation test [ Time Frame: 8 weeks ]
    Assessment of visuospatial neglect: identification of stars on an A4 page. Score total of number of stars marked, maximum =54

  21. Star cancellation test [ Time Frame: 16 weeks ]
    Assessment of visuospatial neglect: identification of stars on an A4 page. Score total of number of stars marked, maximum =54


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063970


Contacts
Contact: Lucy Wedderburn, BSc 01382 424153 lucywedderburn@nhs.net
Contact: Alex John, PhD 01382 424153 a.john@dundee.ac.uk

Locations
United Kingdom
Ninewells Hospital Recruiting
Dundee, Tayside, United Kingdom, DD1 9SY
Contact: Lucy Wedderburn, BSc    01382 424153    lucywedderburn@nhs.net   
Contact: Alex John, PhD    01382 424153    a.john@dundee.ac.uk   
Principal Investigator: Jacqui Morris, PhD         
Perth Royal Informary Recruiting
Perth, Tayside, United Kingdom, PH1 1NX
Contact: Lucy Wedderburn, BSc    01382 424153    lucywedderburn@nhs.net   
Contact: Alex John, PhD    01382 424153    a.john@dundee.ac.uk   
Sponsors and Collaborators
Glasgow Caledonian University
University of Dundee
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: Jacqui Morris, PhD Glasgow Caledonian University
More Information

Responsible Party: Jacqui Morris, Principal Investigator, Glasgow Caledonian University
ClinicalTrials.gov Identifier: NCT03063970     History of Changes
Other Study ID Numbers: Glasgow Caledonian NMAHP RU
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacqui Morris, Glasgow Caledonian University:
Upper extremity
Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases