|
ISRCTN
|
ISRCTN51553998
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Observation with Intent to Imitate (OTI) combined with Motor Practice (MP) to enhance upper limb recovery early after stroke
|
|
Scientific title
|
Observation with Intent to Imitate (OTI) combined with Motor Practice (MP) to enhance upper limb recovery early after stroke: proof-of-concept trial
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Is there sufficient evidence of benefit from Observation to Imitate combined with Motor Practice (OTI+MP) to justify larger scale clinical trials in stroke survivors with substantial weakness early (3-31 days) after stroke?
|
|
Lay summary
|
|
|
Ethics approval
|
1. Cambridgeshire 3 Research Ethics Committee, approved on 20/11/2008 (ref: 08/H0306/71)
2. Research Governance Approval by East Norfolk and Waveney Research Governance Committee and Research Management Team granted on 03/12/2008 (ref: 2008MFE05L [136-09-08])
|
|
Study design
|
Phase I randomised controlled observer-blind single-centre trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Upper limb paralysis after stroke
|
|
Participants - inclusion criteria
|
1. Adults (both males and females, 18 years +) between 3 and 31 days after stroke with an intact pre-motor area (location of mirror neurons) as confirmed by routine clinical imaging
2. A substantially paretic upper limb as measured by a grip force of between 15% and 65% of that of the non-paretic upper limb
|
|
Participants - exclusion criteria
|
Unable to imitate action with their non-paretic limb (i.e. severe visual, communication or cognitive deficits precluding participation in OTI+MP). This will be assessed by the research therapist sitting along side the potential participant. The research therapist will perform 5 actions and the potential participant will be asked to observe and then perform the actions. This assessment will be videoed and saved onto a computer. The accuracy of observed activity will be assessed by 2 independent assessors from the video film using a three point scale used by Decety and colleagues: 2 = correctly reproduced action; 1 = incorrectly reproduced action; 0 = action not produced. Those scoring 8/10 or above will be considered to have the ability to imitate.
|
|
Anticipated start date
|
12/01/2009
|
|
Anticipated end date
|
31/12/2009
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
24
|
|
Interventions
|
The participants will be randomly allocated to the control and intervention groups in 1:1 ratio.
The control intervention will be routine conventional therapy as provided in the clinical centre. All conventional interventions given, to people in control and experimental groups, will be recorded on a standardised form.
The experimental group will receive Observation with Intent to Imitate with Motor Practice (OTI+MP) therapy in addition to routine conventional therapy as received by the control group. OTI+MP therapy sessions will be daily for 15 working days (15 sessions).
OTI+MP requires the participant to sit alongside the research therapist who will demonstrate the activity to be practiced in the same plane as when the participant will produce the movement. Participants will watch the activity produced by the therapist with the intention of imitating this. They will observe the therapist for 2 minutes. Then for 6 minutes they will perform the activity whilst the therapist adapts her own performance of the activity to emphasise the bits that the participant has the most difficulty with.
In every treatment session there will be 6 blocks of treatment separated by 2-4 minutes of resting. Two activities will be chosen per session. The activities will be individually chosen for each participant so that practice is of activities that participants can do partially or complete with difficulty. Activities will become harder as improvement occurs over time. Activities will be chosen form a standardised list which includes, reaching to pick up a cup, unscrewing a top off a coffee jar and placing coins in a purse.
|
|
Primary outcome measure(s)
|
The following will be assessed at baseline and one/two days after the 15th intervention session:
1. Ability to produce voluntary contraction of paretic muscle, as measured by the Motricity Index – arm section. The rationale for this measure is that OTI therapy is primarily directed at improving the ability to voluntarily contract paretic muscle after stroke. The Motricity Index is a clinical measure of the ability to voluntarily contract paretic muscle. It is an ordinal score with six levels of measurement within each of three categories for the upper limb (pinch grip, elbow flexion and shoulder abduction), has been used widely in clinical research, is valid, reliable and sensitive to change after stroke.
2. Ability to produce force in paretic muscle, as measured by torque about the elbow joint during isometric flexion concentric contraction using a digital myometer and maximum pinch and grip force during isometric concentric contraction using a digital pinch/grip analyser (MIE Medical Research Ltd, UK).
3. Ability to use the paretic upper limb in functional activity as measured by the Action Research Arm Test (ARAT). This is a test of upper limb function with subsections covering grasp, grip, pinch and gross movement. It has good validity and reliability and is widely used in clinical research.
4. Adverse event monitoring and recording. There is a small risk that for some people the therapy might lead to an 'overuse' syndrome which presents as pain in the arm and/or hand. We will monitor this by checking for participant report of upper limb pain, either verbal or behavioural (e.g., grimacing, postural guarding), and for decrease in Motricity Index upper limb score of at least two measurement levels.
|
|
Secondary outcome measure(s)
|
No secondary outcome measures
|
|
Sources of funding
|
University of East Anglia (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Valerie
Pomeroy
|
|
Address
|
The Queens Building
University of East Anglia
|
|
City/town
|
Norwich
|
|
Zip/Postcode
|
NR4 7TJ
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1603 591724
|
|
Fax
|
+44 (0)1603 593166
|
|
Email
|
v.pomeroy@uea.ac.uk
|
|
Sponsor
|
University of East Anglia (UK)
|
|
Address
|
Research and Business Services
|
|
City/town
|
Norwich
|
|
Zip/Postcode
|
NR4 7TJ
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.uea.ac.uk/
|
|
Date applied
|
08/01/2009
|
|
Last edited
|
30/01/2009
|
|
Date ISRCTN assigned
|
30/01/2009
|
