This study aims to find the effectiveness of motor imagery techniques in reducing the walking energy cost of stroke patients.
Design
Two-arm parallel-group randomized trial with blinded postoperative care and outcome assessment
Settings and conduct
data will be collected from Rehman Medical institute Peshawar Pakistan. from 31st March 2022. the total duration of the trial will be 6 weeks. patients will be randomly allocated to the experimental and control groups. The experimental group will receive motor imagery techniques along with conventional Physical therapy however the control group will receive only conventional physical therapy. Both groups will receive 3 sessions per week for a total of six weeks. at the end of the study, a blinded assessor will assess the outcomes of walking energy costs from all the recruited patients.
Participants/Inclusion and exclusion criteria
Mini-mental state examination score equals or greater than 24.
Modified Ashworth scale score less than or equal to +1.
Manual muscle testing equals or greater than 3.
Other neurological disorders excluded
Unilateral neglect
Unstable cardiovascular patient
Acute stroke patient with evidence of flaccidity
Intervention groups
the intervention group will be provided with a motor imagery session for 15 minutes followed by 30 minutes of conventional therapy a total of 45 minutes sessions 3 times per week will be given. in the control group, only conventional physical therapy and gait training exercises will be given to the patients the total duration of the session will be 45 minutes 3 times per week for a total of 6 weeks.
Main outcome variables
the main outcomes will be gait improvement which will be checked using the Gait Assessment and intervention tool. and energy expenditure will be checked using Physiological cost index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211011052727N3
Registration date:2023-04-10, 1402/01/21
Registration timing:prospective
Last update:2023-04-10, 1402/01/21
Update count:0
Registration date
2023-04-10, 1402/01/21
Registrant information
Name
Salman farooqi
Name of organization / entity
Khyber Medical University Peshawar Pakistan
Country
Pakistan
Phone
+92 91 5823496
Email address
salman.farooqi@kmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-15, 1402/01/26
Expected recruitment end date
2023-05-30, 1402/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of motor imagery on hemiplegic gait and walking energy cost in sub-acute stroke patients
Public title
Effectiveness of motor imagery on hemiplegic gait and walking energy cost in sub-acute stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mini mental state examination score>24
Modified ashworth scale score>3
Manual muscle testing >3
Age between 40 - 75
Exclusion criteria:
Other neurological disorder excluded unstable acute stroke patient
Unilateral neglect
Cardiovascular patient
Cardiovascular patient
With evidence of flaccidity
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
After meeting the inclusion criteria and giving a written informed consent, a total of 44 patients will be enrol in this study. These participants will be randomly allocated into two groups namely; the Experimental group (motor imagery along with conventional therapy) and the Control group (conventional therapy only). The random allocation will be performed by using sealed envelope (opaque). Total 44 envelopes will be made, 22 will be having a paper with group A (control group) written on it and 22 will have group B (experimental group). This will be for equal distribution of subjects in the two groups. Each participant will be asked to pick an envelope and will handed over to the researcher. Participants will not be blinded about their allocation. All the participants will be inform about the goals and intervention of the study by providing details.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor who will be recording the outcome scores will be blinded he will not be aware weather the participant was in control group or experimental one.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutionl ethical review committee. Institute of Physical Medicien and rehabilitation Khyber Medi
Street address
Hayatabad phase 5
City
Peshawar
Postal code
25001
Approval date
2022-06-20, 1401/03/30
Ethics committee reference number
KMU/IPMR/IERC/22-06-09
Health conditions studied
1
Description of health condition studied
Stroke rehabilitation
ICD-10 code
G81
ICD-10 code description
Hemiplegia and hemiparesis
Primary outcomes
1
Description
Physiological cost index
Timepoint
the outcome will be checked pre intervention then on 2nd and 4th week after intervention and finally on 6th week post intervention
Method of measurement
the formula to calculate the physiological cost index is exercising heart rate minus resting heart rate divided by walking velocity. ( heart rate will be recorded using a pulse oximeter and walking velocity will be measured using 6-meter walk test)
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group:" All the recruited patients in the interventional group will start each session with a mental rehearsal of the motor imagery technique for 15 minutes followed by 30 minutes of conventional physical therapy techniques including gait training exercises and Neuro-developmental techniques each session will last for 45 minutes. The patients will attend 3 sessions per week for a total of 6 weeks. The patient's baseline assessment includes walking speed, resting heart rate, oxygen saturation, and walking energy cost will be calculated using the physiological cost index.
Category
Rehabilitation
2
Description
Control group: Patients in the control group will attend 45 minutes of conventional physical therapy techniques including gait training exercises and Neuro-developmental techniques each session will last for 45 minutes. The patients will attend 3 sessions per week for a total of 6 weeks. At the end of 6 weeks patient walking energy cost will be calculated by a blinded assessor.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehman Medical Institute
Full name of responsible person
Dr Shakir Ullah
Street address
Hayatabad peshawar
City
Peshawar
Postal code
25001
Phone
+92 332 9344799
Email
shakir.ullah@kmu.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khyber Medical University
Full name of responsible person
Dr Masood Ifrah
Street address
Hayatabad Phase 5 Peshawar Pakistan
City
Peshawar
Postal code
25001
Phone
+92 321 6710675
Email
ifrah.masood@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khyber Medical University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Khyber Medical University
Full name of responsible person
Salman Farooqi
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
264 F6, phase 6 hayatabad
City
Hayatabad peshawar
Province
Khyber pukhroon khwa
Postal code
25001
Phone
+92 91 5823496
Email
Salman.farooqi@email.rmi.edu.pk
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khyber Medical University
Full name of responsible person
Salman Farooqi
Position
Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
264 F6, Phase 6 Hayatabad
City
Hayatabad Peshawar
Province
Khyber Pukhtoon Khwa
Postal code
25001
Phone
+92 91 5823496
Email
salman.farooqi@kmu.edu.pk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Khyber Medical University
Full name of responsible person
fahad Ali
Position
teaching Assistant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Hayatabad
City
Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25001
Phone
+92 91 9217266
Email
fahadali.ipmr@kmu.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
as this is the first trail on this case the initial plan is not to disclose it in the beginning.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available