Trial no.:	PACTR202308639720748	Date of Registration:	10/08/2023
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

Spatiotemporal Gait parameters of chronic stroke patients while making a call or carrying a load.

Official scientific title

Spatiotemporal Gait parameters of chronic stroke patients while making a call or carrying a load.

Brief summary describing the background and objectives of the trial

One of the most leading causes to life-long disability is stroke. It’s estimated that 25% of adults world-wide has a risk of developing a stroke during their life-time.Stroke has a major negative impact on the ambulatory function due to disturbances in muscle tone, strength , co-ordination and central processing . Stroke impairs the normal gait cycle causing the hemiplegic limb to take more time during swing and less time during stance which means an increase in double support time and a decrease in single- limb support . As a result, Stroke survivors take longer step with the affected side with weight bearing asymmetry, putting less weight on the affected side which impairs their balance and increase the risk of falling.Also, Overall hip muscle strength of paretic side mainly hip abductors and extensors had a moderate correlation with weight asymmetry and gait speed. Gait impairments in patients with chronic stroke are accentuated when another activity is done simultaneously. Smartphone use induces cognitive distraction, reduces visual attentionto the environment that may impair gait parameters especially as stroke survivors with weight asymmetry had greater visual dependence for the control of postural sway velocity in the medial-lateral direction while walking. Overall hip muscle weakness of paretic sidecauses weight asymmetry and impairs gait speed post stroke. So, carrying a load in the less-affected upper extremity puts excessive gravitational adduction torque on the weak hip abductors of paretic limb which may affect the Single limb support time and decrease weight bearing on the paretic side disturbing balance and increasing the chance of falling.Our aim in this study is to understand more about the effect of common daily activities (Carrying a load and talking on the phone) on weight bearing asymmetry and other gait parameters in patients with chronic stroke.

Type of trial

Observational

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Musculoskeletal Diseases,Nervous System Diseases

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Prevention

Anticipated trial start date

08/03/2023

Actual trial start date

20/07/2023

Anticipated date of last follow up

31/08/2023

Actual Last follow-up date

15/09/2023

Anticipated target sample size (number of participants)

60

Actual target sample size (number of participants)

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously	Non-randomised		Allocation was determined by the holder of the sequence who is situated off site	Open-label(Masking Not Used)

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	stroke patients	Three time , Each 6 minutes	Each 6 minutes	assessment of gait parameters during 3 phases: 1-Normal Walking using treadmill and 2-walking carring a load and 3-walking while making a call	30
Control Group	Healthy group	Three times	6 Min.	Assessment of gait : 1- normal walking 2- walking while making a call 3- walking while carring a load	30	Uncontrolled

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
30 patient with stroke will be recruited from the outpatient clinic in the faculty and 30 healthy controls will be recruited from the university staff. All subjects would go a preliminary assessment session to collect demographic data and check for inclusion and exclusion criteria. Inclusion criteria:  Diagnosis of stroke by a certified neurologist.  More than 18 years old at the beginning of the study.  Stroke happened in the last 1 to 3 years (chronic stroke).  Being able to walk independentlyfor a minimum of 5 minutes without a walking aid. .	Exclusion criteria:  Uncontrolled cardiovascular pathology.  Lower limb fracture in the past 6 months.  Other neurological conditions that might affect gait. Impaired cognitive function evident by a score equal to or lower than six in Appreviated mental test score	Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s)	50 Year(s)	70 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

No

08/03/2023

Research Ethical committe of faculty of physical therapy at cairo university

Ethics Committee Address
Street address	City	Postal code	Country
11 ahmed al zayat st, bein al sarayat ,dokki , Giza	Giza	12612	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Gait parameters using Biodex gait trainer 2 -- Cadence, Velocity , Step length, anf weight distribution on each foot	after each one of the three condition , cross sectional assessment
Secondary Outcome	Fatigue scale	after the end of each trail

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Faculty of physical therapy labs at Cairo University	11 ahmed El zayat ST. Bein El sarayat , Dokki, Giza	Giza	12612	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Faculty of Physical Therapy at cairo university	11 Ahmed el zayat st, Bein al sarayat, Dokki , Giza	Giza	12612	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Faculty of Physical Therapy at cairo university	11 Ahmed El-Zayat st, Dokki	giza	12612	Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Dr Hoda Zakaria	dr_hodazakaria@yahoo.com	+201286273379	11 ahmed al Zayat st, bein al sarayat
City	Postal code	Country	Position/Affiliation
Giza		Egypt	Professor of Physical therapy at Faculty of Physical Therapy Cairo University
Role	Name	Email	Phone	Street address
Public Enquiries	Mahmoud Abo Raya	mahmoud_aboraya@cu.edu.eg	+201284353596	11 ahmed el zayat
City	Postal code	Country	Position/Affiliation
Giza		Egypt	Assistant Lecturer
Role	Name	Email	Phone	Street address
Scientific Enquiries	Mostafa Fahmy	alsaid_mostafa@pt.cu.edu.eg	+201286273379	11 ahmed al Zayat St
City	Postal code	Country	Position/Affiliation
Giza		Egypt	Assistant Lecturer

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	All of Individual Participant Data (IPD) collected during the trial , After deidentification will be shared for research purposes only	Informed Consent Form	Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months.	Only Researchers in the project can see the data
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial description	20/06/2023	More illustration of the idea of research work	Our aim in this study is to understand the effects of mobile phone use as an usual cogntive task or carrying weights as a common activity of daily life on gait parameters on patients with chronic stroke. any increase in gait abnormalities and asymmetry expose stroke patient to a higher risk of fall .	One of the most leading causes to life-long disability is stroke. It’s estimated that 25% of adults world-wide has a risk of developing a stroke during their life-time.Stroke has a major negative impact on the ambulatory function due to disturbances in muscle tone, strength , co-ordination and central processing . Stroke impairs the normal gait cycle causing the hemiplegic limb to take more time during swing and less time during stance which means an increase in double support time and a decrease in single- limb support . As a result, Stroke survivors take longer step with the affected side with weight bearing asymmetry, putting less weight on the affected side which impairs their balance and increase the risk of falling.Also, Overall hip muscle strength of paretic side mainly hip abductors and extensors had a moderate correlation with weight asymmetry and gait speed. Gait impairments in patients with chronic stroke are accentuated when another activity is done simultaneously. Smartphone use induces cognitive distraction, reduces visual attentionto the environment that may impair gait parameters especially as stroke survivors with weight asymmetry had greater visual dependence for the control of postural sway velocity in the medial-lateral direction while walking. Overall hip muscle weakness of paretic sidecauses weight asymmetry and impairs gait speed post stroke. So, carrying a load in the less-affected upper extremity puts excessive gravitational adduction torque on the weak hip abductors of paretic limb which may affect the Single limb support time and decrease weight bearing on the paretic side disturbing balance and increasing the chance of falling.Our aim in this study is to understand more about the effect of common daily activities (Carrying a load and talking on the phone) on weight bearing asymmetry and other gait parameters in patients with chronic stroke.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Actual trial start date	22/06/2023	I made a mistake as I wrote the same date in both fields while I haven't begun the actual study and it was a pilot one for detection of ideal methodology	08 Mar 2023	20 Jul 2023
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Anticipated date of last follow up	22/06/2023	I made a mistake as I haven't begun the actual study and it was a pilot one for detection of ideal methodology	15 Jul 2023	31 Aug 2023
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Completion date	22/06/2023	I made a mistake as I haven't begun the actual study and it was a pilot one for detection of ideal methodology	20 Jul 2023	15 Sep 2023
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	21/06/2023	Misunderstanding between approval decision by the committee and the written approval copy	FALSE, Research Ethical committe of faculty of physical therapy at cairo university , 11 ahmed al zayat st, bein al sarayat ,dokki , Giza, Giza, 12612, Egypt, 25 Jul 2023, , +201286273379, eth.com@pt.cu.edu.eg,	TRUE, Research Ethical committe of faculty of physical therapy at cairo university , 11 ahmed al zayat st, bein al sarayat ,dokki , Giza, Giza, 12612, Egypt, 25 Jul 2023, 15 Jul 2023, +201286273379, eth.com@pt.cu.edu.eg,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	22/06/2023	I made a mistake while submitting the trial information as I haven't begun the actual study and it was a pilot one for detection of ideal methodology and misunderstanding between the date of application for approval and the date of getting the hard copy of approval	TRUE, Research Ethical committe of faculty of physical therapy at cairo university , 11 ahmed al zayat st, bein al sarayat ,dokki , Giza, Giza, 12612, Egypt, , 15 Jul 2023, +201286273379, eth.com@pt.cu.edu.eg,	FALSE, Research Ethical committe of faculty of physical therapy at cairo university , 11 ahmed al zayat st, bein al sarayat ,dokki , Giza, Giza, 12612, Egypt, 08 Mar 2023, 15 Jul 2023, +201286273379, eth.com@pt.cu.edu.eg,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	27/07/2023	It was required to complete the registeration	FALSE, Research Ethical committe of faculty of physical therapy at cairo university , 11 ahmed al zayat st, bein al sarayat ,dokki , Giza, Giza, 12612, Egypt, 08 Mar 2023, , +201286273379, eth.com@pt.cu.edu.eg,	FALSE, Research Ethical committe of faculty of physical therapy at cairo university , 11 ahmed al zayat st, bein al sarayat ,dokki , Giza, Giza, 12612, Egypt, 08 Mar 2023, , +201286273379, eth.com@pt.cu.edu.eg, 25638_24511_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	10/08/2023	Stamped and signed as required	FALSE, Research Ethical committe of faculty of physical therapy at cairo university , 11 ahmed al zayat st, bein al sarayat ,dokki , Giza, Giza, 12612, Egypt, 08 Mar 2023, , +201286273379, eth.com@pt.cu.edu.eg, 25638_24511_4737.pdf	FALSE, Research Ethical committe of faculty of physical therapy at cairo university , 11 ahmed al zayat st, bein al sarayat ,dokki , Giza, Giza, 12612, Egypt, 08 Mar 2023, , +201286273379, eth.com@pt.cu.edu.eg, 25638_24511_4737.pdf
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Ethics	Ethics List	02/05/2025	Stamped and signed as required	FALSE, Research Ethical committe of faculty of physical therapy at cairo university , 11 ahmed al zayat st, bein al sarayat ,dokki , Giza, Giza, 12612, Egypt, 08 Mar 2023, , +201286273379, eth.com@pt.cu.edu.eg, 25638_24511_4737.pdf	TRUE, Research Ethical committe of faculty of physical therapy at cairo university , 11 ahmed al zayat st, bein al sarayat ,dokki , Giza, Giza, 12612, Egypt, 08 Mar 2023, 11 Jun 2023, +201286273379, eth.com@pt.cu.edu.eg, 25638_24511_4737.pdf

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