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 -

SLCTR Registration Number

SLCTR/2017/031


Date of Registration

22 Sep 2017

The date of last modification

Sep 22, 2017



Application Summary


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 of Health Condition(s) Studied

Stroke


Scientific Acronym

None


Public Acronym

None


Brief title

Motor imagery for people with stroke


Universal Trail 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)


Trial Details


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


Assignment

Parallel


Purpose

Supportive care


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

  1. Age between 18 and 80 years
  2. A diagnosis of hemiplegia due to stroke (infarct or hemorrhage)
  3. Stroke experienced more than 3 months prior to enrollment (Summers et al., 2007)
  4. Able to complete Advanced Hand Activities 1, 2 and 3 of Motor Assessment Scale (Carr, et al.,1985)
  5. Score of more than 24 points on the Mini-Mental State Exam (dictates no cognitive deficits) (Folstein, et al., 1975)
  6. Able to give voluntary consent to participate in the study.

Exclusion criteria

  1. Visual and perceptual problems including hemianopia and unilateral neglect
  2. Excessive pain in the affected arm as measured by score of more than 4 on a 10-point Visual Analog Scale (Scott & Huskisson, 1976)
  3. Spasticity of more than 3 on Modified Ashworth Scale (Bohannon & Smith, 1987)
  4. Pre-existing musculoskeletal, neurological (apart from stroke) or other conditions that may affect upper limb function.


Primary outcome(s)

  1. Hand function: assessed by Jebsen-Taylor Hand Function Test (JTHFT) (Jebsen, Taylor, Trieschmann, Trotter, & Howard, 1969)

  2. Perceived hand function: assessed by Motor Activity Log (MAL) (Duncan, Propst, & Nelson, 1983].


Primary outcome(s) - Time of assessment(s)

At baseline, six weeks (end of intervention) and 10 weeks after the end of intervention.


Secondary outcome

  1. Vividness of imagery: assessed by Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) (Roberts, Callow, Hardy, Markland, & Bringer, 2008)

  2. Upper extremity impairment: assessed by Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) (Sanford, Moreland, Swanson, Stratford, & Gowland, 1993)

  3. Finger dexterity: assessed by Nine Hole Peg Test (NHPT) (Mathiowetz et al., 1985)

  4. In-hand manipulation: assessed by In-Hand Manipulation Assessment (IHMA) (Klymenko et al., under review)

  5. Independent living skills: assessed by Lawton Instrumental Activities of Daily Living Scale (IADL) (Lawton & Brody, 1988)

  6. Self-perception of performance: assessed by Canadian Occupational Performance Measure (COPM) (Law et al., 1998)

  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)


Secondary outcome(s) - Time of assessment(s)

  1. Vividness of imagery: assessed by Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) (Roberts, Callow, Hardy, Markland, & Bringer, 2008)

  2. Upper extremity impairment: assessed by Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) (Sanford, Moreland, Swanson, Stratford, & Gowland, 1993)

  3. Finger dexterity: assessed by Nine Hole Peg Test (NHPT) (Mathiowetz et al., 1985)

  4. In-hand manipulation: assessed by In-Hand Manipulation Assessment (IHMA) (Klymenko et al., under review)

  5. Independent living skills: assessed by Lawton Instrumental Activities of Daily Living Scale (IADL) (Lawton & Brody, 1988)

  6. Self-perception of performance: assessed by Canadian Occupational Performance Measure (COPM) (Law et al., 1998)

  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)



Target number/sample size

60 (20 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2017-09-25


Anticipated end date

2018-09-30


Recruitment status

Pending


State of ethics review approval

Approved by the Ethical Review Committee of Faculty of Medicine University of Kelaniya on 19th June 2017 (Ref. No.: P/154/06/2017)


Funding source

PhD scholarship at Western Sydney University



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None