Effects of routine physical therapy with and without action observation therapy on freezing of gait and functional mobility in patients with parkinson’s disease
The objective was study the effects of routine physical therapy with and without Action
observation on freezing of the gait andfunctional mobility in patients with Parkinson’s
disease.
Design
Randomized, parallel group design of 21 patients, single blinded randomized control trial.
Settings and conduct
Study was conducted at THQ Civil Hospital Daska. The study population was consisted of Parkinson's Disease, The study was single blinded. The outcome assessors did not know while they were receiving experimental or conventional treatment
Participants/Inclusion and exclusion criteria
Inclusion
1. The participants with set diagnostic criteria of UK society for Parkinson’s Disease Bank Criteria
based on clinical findings.
2. Age between 50 to 80
3. The patients were selected on the condition of severely affected gait and enrolled if there was
freeing of their gait minimum once in a week (having a score of 1 on FOG outcome tool in item
No.2) and having a larger episode of greater than 2 seconds (and if have 2 scores on the FOG
item No. 4)
4. Hoehn & Yahr criteria with labeled as stage ≤ 3
Exclusion Criteria:
1. Any of the substance abuse ,illness systematic disease and neurological issues that can affect the
outcomes including cognition level
2. Implantation for deep brain stimulation
3. Cognitive impairment, in particular patients with a Mini mental State Examination (MMSE)
score < 24
4. Visual or acoustic limitations.
Intervention groups
Group A-(Routine Physical Therapy)
Group (B) (RPT+ AOT)
In this group patient were treated with action observation therapy (AOT) as well as with routine
physicaltherapy (RPT).
Main outcome variables
Freezing of Gait and functional mobility.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230723058901N1
Registration date:2023-10-06, 1402/07/14
Registration timing:retrospective
Last update:2023-10-06, 1402/07/14
Update count:0
Registration date
2023-10-06, 1402/07/14
Registrant information
Name
Kiran Maqsood
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 323 9578501
Email address
kiranfaryal555@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
2023-05-22, 1402/03/01
Actual recruitment end date
2023-06-22, 1402/04/01
Trial completion date
2023-07-22, 1402/04/31
Scientific title
Effects of routine physical therapy with and without action observation therapy on freezing of gait and functional mobility in patients with parkinson’s disease
Public title
Effects of action observation therapy on freezing of gait and functional mobility in patients with Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
participants with clinical diagnosis of PD according to UK Parkinson's Disease Society Brain Bank criteria
Age between 50 to 80
In order to select PD subjects for those FoG severely impacted gait, patients were enrolled ifthe occurance of freezing was at least once a week (minimum score of 1 on item 2 in the new FoG Questionnaire (FoG-Q)) and the longest episodes was > 2 seconds (minimum score of 2 on item 4 of the FoG-Q
Hoehn & Yahr (H&Y) stage ≤ 3
Exclusion criteria:
medical illnesses or substance abuse that could interfere with cognition; any (other) major systemic or neurological illness.
implantation for deep brain stimulation
cognitive impairment, in particular patients with a Minimental State Examination (MMSE)score < 24
visual or acoustic limitations
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
21
Actual sample size reached:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study was conducted using a computer-generated randomization method. The unit of randomization was at the individual level, where each participant was assigned to one of two groups. The random sequence was constructed using specialized software designed for randomization purposes. Allocation concealment was rigorously carried out through the use of opaque sealed envelopes. These envelopes were prepared in advance and remained sealed until each participant's allocation decision was made.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was single blinded the outcome assessor didn’t know while they were receiving experimental or conventional treatment
Placebo
Not used
Assignment
Parallel
Other design features
Time up and go test for functional mobility and freezing of gait(FOG) questionnaire to assess freezing of gait.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethical Committee, Faculty of Allied Health Sciences, The University of Lahore
Street address
-Km Defence Road،, near Bhuptian Chowk،, Lahore
City
Lahore
Postal code
54590
Approval date
2023-05-22, 1402/03/01
Ethics committee reference number
REC-UOL-421-06-2023
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Freezing of gait
Timepoint
at baseline week 6 and week 12
Method of measurement
FOG (freezing of gait questionnaire)
2
Description
Functional Mobility
Timepoint
at baseline week 6 and week 12
Method of measurement
TUG (Time Up and Go test)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group patient were treated with routine physical therapy. The exercise program consists of stretching, strengthening and isometric exercise based on the severity of functional mobility and freezing of Gait. According to the patient‘s physical condition, the therapist conducted each treatment for 45 minutes, once a day, 5 times a week, for a total of12 weeks.
Category
Rehabilitation
2
Description
Intervention group: In this group patient were treated with action observation therapy (AOT) as well as with routine physical therapy (RPT).To reduce the aspects of freezing of gait, the tasks were assigned to the persons who took participate in the daily sessions of thirty minutes twice a day. These aspects include ankle tapping, taking back and forth steps and counting the steps during walk. In these sessions, the patient was asked to follow every step and movement of therapist
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
THQ Civil Hospital Daska
Full name of responsible person
Dr Jansher Mansoori
Street address
1 Stadium Rd, Habibpura
City
Daska
Postal code
51010
Phone
+92 321 5909269
Email
jansher.mansoor31@gmail.com
Web page address
https://thqdaska.punjab.gov.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
THQ Civil Hospital
Full name of responsible person
Dr Jansher Mansoori
Street address
Stadium Rd, Habibpura
City
Daska
Postal code
51010
Phone
+92 321 5909269
Email
jansher.mansoor31@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and data related to final outcome will be shared by maintaining the confidentiality.
When the data will become available and for how long
Data will be available from April 2024 to June 2024 after the six months of Publication. The data sharing plan for the clinical trial(i.e., what data will be shared when and under what conditions) will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's international clinical trial registry platform , this occur before the first participant is enrolled.
To whom data/document is available
Dr Kiran Maqsood( Corresponding Author )
Under which criteria data/document could be used
For Research Purpose
From where data/document is obtainable
To the Corresponding Author of the study; dr Kiran Maqsood and can contact on +923239578501, Kiranfaryal555@gmail.com can visit the search engines, you can find my study data will be available from April 2024 to June 2024 after six months of publication. The data sharing plan for the clinical trial(i.e., what data will be shared when and under what conditions) will be publicly available at a third-party site that shares data with and meets the data requirements of WHO's international clinical trial registry platform , this occur before the first participant is enrolled.
What processes are involved for a request to access data/document
Open Access and there is the traditional public data release where anyone can get access to the data with no registration or conditions. The request will be reviewed by director in charge and in case of eligibility, it would be shared in two weeks.