The aim of this quasi-experimental Pre/Post study design was to examine the efficacy of gait training exercises in reducing the energy cost (EC) of walking in post-stroke patients. The secondary objective was to assess the impact of gait training on overall gait pattern. .
Design
A single group quasi experimental pre-test post study design.
Settings and conduct
The data collection will be performed in the institute of physical medicine and rehabilitation Khyber Medical University Pakistan after approval of the clinical trial registry. as this will be a single group trial we will not follow any blinding process.
Participants/Inclusion and exclusion criteria
Patients having history of stroke at least 3 months before the start of the study, Stroke patients walking Independently (with or without assisted devices). With a score of 3 or above on Fictional Ambulatory Category (FAC). Patients having mini mental status score greater than 24..were included in the study.
The patients with major psychological disorders or inability to follow commands were excluded from study.
Patient who experienced pain during walking.Stroke patients with the history of unliteral neglect was also excluded.
Intervention groups
The total duration of the intervention will be for six weeks with three sessions per week the total sessions of gait training exercises administered to stroke patient will be 18. The overall duration of each session will last for 60 minutes. the gait training exercise intervention includes, Range of Motion Exercises, Lower Extremity Strengthening, Stepping Over Obstacles, Side-Stepping Gait Exercises, Target Stepping, Retro Walking, Balance and Proprioception Exercises.
Main outcome variables
The energy cost of the participants will be calculated using Physiological cost index PCI which is a valid and reliable tool. for gait assessment the Gait intervention and assessment tool will be used.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211011052727N2
Registration date:2023-03-10, 1401/12/19
Registration timing:prospective
Last update:2023-03-10, 1401/12/19
Update count:0
Registration date
2023-03-10, 1401/12/19
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
2023-03-15, 1401/12/24
Expected recruitment end date
2023-04-15, 1402/01/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Stepping Forward: Evaluating the Impact of Gait Training on Post-Stroke Patients' Energy Cost of Walking
Public title
Effectiveness of Gait Training Exercises for Post-Stroke Gait Pattern Improvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients having history of stroke at least 3 months before the start of the study.
Stroke patients having the capability to walk Independently (with or without assisted devices). With a score of 3 or above on Fictional Ambulatory Category (FAC)
Patients having mini mental status score greater then 24
Medically stable patients with no known case of uncontrolled Hypertension, arrhythmia, or unstable cardiovascular diseases
No significant Musculoskeletal problems relating to conditions other than stroke
Patients having the age of 18 or above were included in the study
Exclusion criteria:
The patients with major psychological disorders or inability to follow commands were excluded from study.
Patients with history of Myocardial Infarction before stroke or known case of angina were excluded
Patients having previous history of Chronic obstructive pulmonary disease (COPD), or other chronic respiratory disorders were excluded from the study
Patient who experienced pain during walking.• Stroke patients with the history of unliteral neglect was also excluded.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Quasi experimental pre-test post-test study design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committe of the institute of physical medicine and rehabilitation khyber medical university
Street address
Phase 5 street 1 Hayatabad
City
Peshawar
Postal code
25100
Approval date
2022-03-05, 1400/12/14
Ethics committee reference number
KMU/IPMR/IERC/03-22/11
Health conditions studied
1
Description of health condition studied
sub acute stroke patients with level 3 on functional ambulatory category
ICD-10 code
G81.9
ICD-10 code description
Hemiplegia, unspecified
Primary outcomes
1
Description
The walking energy cost of stroke patients
Timepoint
the walking energy cost will be calculated before intervention then at 3 weeks post intervention and finally at the end of 6th week of intervention
Method of measurement
The walking energy cost of stroke patients will be calculated using the Physiological cost index
Secondary outcomes
1
Description
level of spasticity
Timepoint
pre intervention and post intervention
Method of measurement
Modified Ashworth Scale
Intervention groups
1
Description
Intervention group: As this study will involve only one group, all eligible patients will receive an intervention consisting of gait training exercises. These exercises will include range of motion exercises, lower limb strengthening exercises, stepping over obstacles, side stepping gait exercises, target stepping, and retro walking. Each exercise session will last 60 minutes, and patients will receive gait training exercise intervention three times per week. The study will last for a total of six weeks, during which patients will participate in a total of 18 gait training exercise sessions
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Khyber Medical University Pakistan
Full name of responsible person
Farooqi Salman
Street address
PHase 5 street 1 Hayatabad
City
Peshawar
Postal code
25100
Phone
+92 91 5823496
Email
salman.farooqi@kmu.edu.pk
Web page address
https://kmu.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Capital Medical University/ China Rehabilitation and Research Center
Full name of responsible person
Professor Zhang Tong
Street address
Fengtai District Beijing
City
Beijing
Postal code
100068
Phone
+86 135 2099 4786
Email
sunshine0691@163.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Capital Medical University/ China Rehabilitation and Research Center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
CN
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
Master
Other areas of specialty/work
Physiotherapy
Street address
264 F6, Phase 6 Hayatabad
City
Hayatabad Peshawar
Province
Khyber PukhtoonKhwa
Postal code
25100
Phone
+92 91 5823496
Email
salmankmu@gmail.com
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
Master
Other areas of specialty/work
Physiotherapy
Street address
264 F6, Phase 6 Hayatabad
City
Hayatabad Peshawar
Province
Khyber Pukhtoonkhwa
Postal code
25100
Phone
+92 91 5823496
Email
salmankmu@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Khyber Medical University
Full name of responsible person
Salman Farooqi
Position
Lecturee
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
264 F6, Phase 6 Hayatabad
City
Hayatabad Peshawar
Province
khyber PukhtoonKhwa
Postal code
25100
Phone
+92 91 5823496
Email
salmankmu@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available