Home » Trials » SLCTR/2017/031
Effectiveness of first-person and third-person motor imagery in relearning daily hand tasks for people with chronic stroke: A randomised controlled trial
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SLCTR Registration Number
SLCTR/2017/031
Date of Registration
The date of last modification
Oct 18, 2021
Trial Status
Scientific Title of Trial
Effectiveness of first-person and third-person motor imagery in relearning daily hand tasks for people with chronic stroke: A randomised controlled trial
Public Title of Trial
Relearning daily hand tasks for people with chronic stroke
Disease or Health Condition(s) Studied
Stroke
Scientific Acronym
None
Public Acronym
None
Brief title
Motor imagery for people with stroke
Universal Trial Number
U1111-1199-8975
Any other number(s) assigned to the trial and issuing authority
P/154/06/2017 (ERC: Kelaniya) AAJ/ETH/COM/2017-08 (ERC: NHSL, Colombo) AA/04/2017/596 (ERC: CSTH, Kalubowila)
What is the research question being addressed?
What is the effectiveness of first-person and third-person motor imagery in relearning daily hand tasks for people with chronic stroke?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Study settings Occupational Therapy Unit at: 1. Colombo North Teaching Hospital, Ragama 2. Rheumatology and Rehabilitation Hospital,Ragama 3. The National Hospital of Si Lanka, Colombo 10 4. Colombo South Teaching Hospital, Kalubowila
Method of randomisation
Simple randomisation using a computer-generated randomization table by an independent research
person.
Details of the intervention
There will be three study arms:
1. First-person imagery group
2. Third-person imagery group
3. Conventional occupational therapy (control) group
All participants will receive individual training on daily hand tasks such as turning pages of a newspaper, eating a biscuit, using comb etc. The program will be conducted 45 minutes a day, two times a week for 6 weeks. The intervention will be conducted in the occupational therapy unit or in a quiet area free of distraction.
Arm 1 (First-person imagery group): Participants will imagine themselves doing the task and then actually perform the task in the first-person imagery group.
Arm 2 (Third-person imagery group): Participants will imagine a person doing the task and then actually perform the task in the third-person imagery group.
Arm 3 (Control group): Participants will receive conventional occupational therapy which encompasses actual practice of the daily hand tasks for 45 minutes. The frequency, duration, number of sessions, and the sequence and training schedule will be the same as for the intervention groups.
Details on blinding
• An independent research person will conduct the randomisation.
• The participants are blinded to which group they are assigned.
• Two occupational therapists not involved in treatment will conduct the assessment for blinding purpose
• The investigators (including the PI) who are involved in data analysis will be blinded to the conditions and group allocation of the participants during analysis of data.
• One investigator who will not be involved in data analysis will rename the groups for data analysis
Inclusion criteria
Exclusion criteria
Primary outcome(s)
1.
Hand function: assessed by Jebsen-Taylor Hand Function Test (JTHFT) (Jebsen, Taylor, Trieschmann, Trotter, & Howard, 1969) |
[ At baseline, six weeks (end of intervention) and 10 weeks after the end of intervention. ] |
2.
Perceived hand function: assessed by Motor Activity Log (MAL) (Duncan, Propst, & Nelson, 1983]. |
[ At baseline, six weeks (end of intervention) and 10 weeks after the end of intervention. ] |
Secondary outcome(s)
1.
Vividness of imagery: assessed by Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) (Roberts, Callow, Hardy, Markland, & Bringer, 2008) |
[ At baseline, six weeks (end of intervention) and 10 weeks after the end of intervention. ] |
2.
Upper extremity impairment: assessed by Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) (Sanford, Moreland, Swanson, Stratford, & Gowland, 1993) |
[ At baseline, six weeks (end of intervention) and 10 weeks after the end of intervention. ] |
3.
Finger dexterity: assessed by Nine Hole Peg Test (NHPT) (Mathiowetz et al., 1985) |
[ At baseline, six weeks (end of intervention) and 10 weeks after the end of intervention. ] |
4.
In-hand manipulation: assessed by In-Hand Manipulation Assessment (IHMA) (Klymenko et al., under review) |
[ At baseline, six weeks (end of intervention) and 10 weeks after the end of intervention. ] |
5.
Independent living skills: assessed by Lawton Instrumental Activities of Daily Living Scale (IADL) (Lawton & Brody, 1988) |
[ At baseline, six weeks (end of intervention) and 10 weeks after the end of intervention. ] |
6.
Self-perception of performance: assessed by Canadian Occupational Performance Measure (COPM) (Law et al., 1998) |
[ At baseline, six weeks (end of intervention) and 10 weeks after the end of intervention. ] |
7.
Health-related quality of life specific to stroke survivors: assessed by Stroke Specific quality of life scale (SS-QOL) (Williams, Weinberger, Harris, Clark, & Biller, 1999) |
[ At baseline, six weeks (end of intervention) and 10 weeks after the end of intervention. ] |
Target number/sample size
60 (20 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-09-25
Anticipated end date
2019-09-30
Date of first enrollment
2017-09-25
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
PhD scholarship at Western Sydney University
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-06-19
Approval number
P/154/06/2017
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
Telephone: | +94-11-2961267 |
Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Nandana Welage
PhD candidate
Western Sydney University,
Locked Bag 1797 Penrith NSW 2751, Australia
n.welage@westernsydney.edu.au
Karen Liu (Supervisor), Associate Professor
Western Sydney University,
Locked Bag 1797, Penrith, NSW 2751
Australia
Tel: +61 2 4620 3432
karen.liu@westernsydney.edu.au
Contact Person for Public Queries
Dr. Padma S. Gunaratne
Consultant Neurologist
Department of Neurology,
The National Hospital of Sri Lanka,
Regent Street, Colombo 10, Sri Lanka
Tel: +94 11 2584325
E-mail: pagunara@gmail.com
Primary study sponsor/organization
Western Sydney University
Western Sydney University
Locked Bag 1797
Penrith
NSW 2751
karen.liu@westernsydney.edu.au
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results