comparsion of the effectiveness of treadmil training alone versus treadmil training with external clues in improving gait and functional ability in parkinson's patient
the aim of the study is to check the effectiveness of the treadmil trainng alone versus treadmil training with external clues in improving gait and functional ability in parkinsion patient
Design
Randomized control trial
Settings and conduct
this trial will be conducted at Physicaltherapy and rehablitation ward of Chauhary akram teaching hospital (Teaching hospital associated with Azra Naheed Medical College ,THe superior University ,Lahore)
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
(1) Age 50 to 65 years
(2) Male and female both
(3) idiopathic Parkinson’s disease
(4) disease severity of II to V on the Hoehn and Yahr Scale and with minimum assistance and support required
(5) ability to stand independently and to walk on a treadmill (with body weight support, if required)
(6) sufficient visual capacity to see the cues
Exclusion Criteria:
(1) Patient with Parkinson disease wheel-chair bond and bed-ridden
(2) any other neurologic or orthopedic disorder affecting gait and postural stability;
(3) change in medication for the treatment of Parkinson’s disease during the study period
(4) cognitive impairment
(5) severe cardiovascular disorders
(6) vestibular dysfunctions
Intervention groups
Interventions:
Group 1 (Control group)
Group 1 in training session will receive the treadmill training session over 30 minutes.
Patients in 1 receive the same treatment protocol in 5 days per week and the this treatment protocol must be continue for 6 weeks.
Group 2 (Experimental Group):
Group 2 in training session received the treadmill training session over 30 minutes along with the external clues like visual, auditory,etc.In 5 days per week and this treatment protocol must be continuing for 6 weeks
Main outcome variables
Gait it will be assesed by usiing wisconsin gait scale and Functional ability wil be assesd by Motor Aspects of Experiences of Daily Living (M-EDL)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220414054537N1
Registration date:2022-06-14, 1401/03/24
Registration timing:retrospective
Last update:2022-06-14, 1401/03/24
Update count:0
Registration date
2022-06-14, 1401/03/24
Registrant information
Name
Faisal Ghafoor
Name of organization / entity
The Superior University
Country
Pakistan
Phone
+92 42 38104221
Email address
faisal.ghafoor@superior.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-20, 1401/02/30
Expected recruitment end date
2022-05-25, 1401/03/04
Actual recruitment start date
2022-05-22, 1401/03/01
Actual recruitment end date
2022-06-05, 1401/03/15
Trial completion date
2022-07-24, 1401/05/02
Scientific title
comparsion of the effectiveness of treadmil training alone versus treadmil training with external clues in improving gait and functional ability in parkinson's patient
Public title
effect of treadmil training alone versus treadmil training with external clues in treatment of parkinsion's
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 50 to 65 years
Male and female both
idiopathic Parkinson’s disease
disease severity of II to V on the Hoehn and Yahr Scale and with minimum assistance and support required
ability to stand independently and to walk on a treadmill (with body weight support, if required)
sufficient visual capacity to see the cues
Exclusion criteria:
Patient with Parkinson disease wheel-chair bond and bed-ridden
any other neurologic or orthopedic disorder affecting gait and postural stability;
change in medication for the treatment of Parkinson’s disease during the study period
cognitive impairment
severe cardiovascular disorders
vestibular dysfunctions
Age
From 50 years old to 65 years old
Gender
Both
Phase
1
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
participants fullfilling the inclusion and exclusion criteria will be allocated randomology into control group and experimental group.the process of allocation will be concealed from participants and the researcher.
Blinding (investigator's opinion)
Single blinded
Blinding description
in our study we used a blinding protocol in which the outcome assesor is fully blind he didnot have the idea about the intervention being provided to the participants, the this process which mostly used in clinical trials in which the participants, investigators and/or assessors remain ignorant concerning the treatments which participants are receiving.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
committe Azra Naheed Centre for Research & Development the Superior University ,Lahore
Street address
main riwind road 17 km ,Lahore
City
Lahore
Postal code
54000
Approval date
2022-05-05, 1401/02/15
Ethics committee reference number
SU/ANCRD/IERC/56
Health conditions studied
1
Description of health condition studied
Parkinson's disease is a brain disorder that causes unintended or uncontrollable movements, such as shaking, stiffness, and difficulty with balance and coordination. Symptoms usually begin gradually and worsen over time. As the disease progresses, people may have difficulty walking and talking
Gait: Gait is the rhythmical movement of the limb and trunks which help in the forward movement of the central of gravity and it help in the shifting of the weight forward. Gait Cycle: Step Length,.Stride length: Stance phase.Swing phase: mid swing Acceleration,deacceleration.Stance phase divided into 5 major sub-division like:Initial contact: rFoot flat: Mid stance: tHeel off: Toe off:
Timepoint
after 6 weeks
Method of measurement
wisconsin gait scale for gait measeuremnt and Functional ability will be assessd by Motor Aspects of Experiences of Daily Living (M-EDL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in both treatments will complete training sessions over 6 weeks (5 sessions per week) and the patient will assess at base line and then it will asses after 6 week respectively. During the first session, all patients will be trained for 20 minutes at their own pace. All patients will complete at least 30 training sessions over 45 minutes at the last session. Group 1 (Control group) Group 1 in training session will receive the treadmill training session over 30 minutes.Patients in 1 receive the same treatment protocol in 5 days per week and the this treatment protocol must be continue for 8 weeks. Group 2 (Experimental Group):Group 2 in training session received the treadmill training session over 30 minutes along with the external clues like visual, auditory,etc.In 5 days per week and this treatment protocol must be continuing for 8 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
committe Azra Naheed Centre for Research & Development the Superior University ,Lahore
Full name of responsible person
Dr zohaib Shahid
Street address
main riwind road 17 km ,Lahore
City
Lahore
Postal code
54000
Phone
+92 333 6979114
Email
zohaib.rana@superior.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
committe Azra Naheed Centre for Research & Development the Superior University
Full name of responsible person
DR Zohaib Shahid
Street address
main riwind road 17 km ,Lahore
City
Lahore
Postal code
54000
Phone
+92 333 6979114
Email
zohaib.rana@superior.edu.pk
Grant name
no
Grant code / Reference number
no
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
no funding
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
committe Azra Naheed Centre for Research & Development the Superior University ,Lahore
Full name of responsible person
Dr Zohaib Shahid
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
main riwind road 17 km ,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 6979114
Email
zohaib.rana@superior.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
committe Azra Naheed Centre for Research & Development the Superior University ,Lahore
Full name of responsible person
Dr zohaib Shahid
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
main riwind road 17 km ,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 6979114
Email
zohaib.rana@Superior.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
committe Azra Naheed Centre for Research & Development the Superior University ,Lahore
Full name of responsible person
Dr Faisal Ghafoor
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Rehabilitation management
Street address
main riwind road 17 km ,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 4816348
Email
faisal.ghafoor@superior.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
comparsion of the effectiveness of the treadmil training alone versus treadmil training with external clues in improving the gait and functional ability in parkinsion's patient
When the data will become available and for how long
data will be availabe on 7 weeks (2022-07-26)
To whom data/document is available
not sured but vailable on request
Under which criteria data/document could be used
on request
From where data/document is obtainable
o request
What processes are involved for a request to access data/document