To determine the effect of Planter Vibration on balance and postural instability in chronic stroke
patients.
Design
Single Blind, randomized controlled clinical trial
Settings and conduct
This randomized clinical trial will be conducted in Department of Physical Therapy and Rehabilitation, Pakistan Railway Hospital, Rawalpindi.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of the participants between 40 to 70 years.
Participants who have stroke ≥ 6 months ago.
Participants who are medically stable.
Able to walk without use of walking aids
Able to understand verbal commands.
Rankin Modified Scale 4 score
Exclusion criteria
Participation in other treatment protocols for balance
Presence of other neurological or musculoskeletal conditions affecting balance
History of fracture or lower-limb surgery within the 12 months
Patients having vestibular, visual or auditory disorders
Abnormal synergies, fixed ankle contractures
Uncontrolled diabetes or hypertension
Use of medication that may affect balance
Unwillingness for participation in the study
Intervention groups
Control Group:
Will receive Strengthening Exercises, Stretching Exercises, Gait Training and
Balancing Exercises.
Treatment group:
Will receive routine physiotherapy treatment plus receive planter vibration for 5 minutes with frequency of 20-40Hz on alternative days 3 times per week for 6 weeks. A planter vibratory device (OTO electro reflexologist ER 839S) will be used to give vibration, during the intervention subjects will be positioned in sitting position, ask to sit on chair with leg flexed and put the most affect foot on vibratory device.
Main outcome variables
The primary outcomes of the study of the study will be berg balance scale
Secondary outcome measures of the study will be stroke quality of life scale and modified postural assessment scale for stroke patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210830052336N1
Registration date:2021-09-06, 1400/06/15
Registration timing:registered_while_recruiting
Last update:2021-09-06, 1400/06/15
Update count:0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Yaser Majeed
Name of organization / entity
Riphah International University, Islamabad, Pakistan
Country
Pakistan
Phone
+92 51 5578434
Email address
yasirmajeed216@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-02, 1400/03/12
Expected recruitment end date
2021-09-20, 1400/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECTS OF PLANTER VIBRATION ON BALANCE AND POSTURAL INSTABLITY IN CHRONIC STROKE PATIENTS
Public title
Single Blind, randomized controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of the participants between 40 to 70 years
Participants who have their first ever stroke ≥ 6 months ago
Participants who are medically stable
Able to walk without use of walking aids
Rankin Modified Scale 4 score
Able to understand verbal commands.
Exclusion criteria:
Participation in other treatment protocols for balance
Presence of other neurological or musculoskeletal conditions affecting balance
History of fracture or lower-limb surgery within the 12 months
Patients having vestibular, visual or auditory disorders
Abnormal synergies, fixed ankle contractures
Uncontrolled diabetes or hypertension
Use of medication that may affect balance
Unwillingness for participation in the study
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly divided into 2 groups (control group A and experimental group B) by coin toss method using convenient sampling technique and informed consent will be taken from each patient who willing to participate in the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
participant will be blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethical Committee, Riphah College of Rehabilitation Sciences Islamabad
Street address
Riphah International University Islamabad City Campus 7th Avenue, Sector G-7/4, Islamabad
City
Islamabad
Postal code
47311
Approval date
2021-05-11, 1400/02/21
Ethics committee reference number
RIPHAH/RCRS/REC/letter-00392
Health conditions studied
1
Description of health condition studied
Patients suffering from Stroke who feel difficulty in performing activities of daily living.
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Berg Balance Scale
Timepoint
Before intervention and after six weeks of intervention.
Method of measurement
Berg Balance Scale constitutes 14 different activities. Each item is scored along a 5-point scale, ranging from 0 to 4, each grade with well-established criteria. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56.
Secondary outcomes
1
Description
The Modified of the Postural Assessment Scale for Stroke Patients (PASS)
Timepoint
Before intervention and weeks after intervention.
Method of measurement
It consists of a 4-point scale where the items are scored from 0 to 3, and the total scoring ranges from 0 to 36
2
Description
Stroke Specific Quality of Life Scale (SS-QOL)
Timepoint
Before intervention and weeks after intervention
Method of measurement
The Stroke Specific Quality of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke. Scoring: each item shall be scored with the following key Total help - Couldn't do it at all - Strongly agree (1), A lot of help - A lot of trouble - Moderately agree (2), Some help - Some trouble - Neither agree nor disagree (3), A little help - A little trouble - Moderately disagree (4) No help needed - No trouble at all - Strongly disagree (5)
Intervention groups
1
Description
Control group:
Category
Rehabilitation
2
Description
Intervention group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Pakistan Railway Hospital ,Rawalpindi, Pakistan.
Full name of responsible person
Mirza Obaid Baig
Street address
Railway Carriage Factory Rd, Railway Scheme 7
City
Rawalpindi
Postal code
46000
Phone
+92 51 4509595
Email
yasirmajeed216@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah international university
Full name of responsible person
Yaser Majeed
Street address
Railway Carriage Factory Rd, Railway Scheme 7
City
Islamabad
Postal code
46000
Phone
+92 51 4509595
Email
yasirmajeed216@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah international university
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Yaser Majeed
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Railway Carriage Factory Rd, Railway Scheme 7
City
Islamabad
Province
Punjab
Postal code
46000
Phone
+92 51 4509595
Email
yasirmajeed216@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International university
Full name of responsible person
Yaser Majeed
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Railway Carriage Factory Rd, Railway Scheme 7
City
Islamabad
Province
Punjab
Postal code
46000
Phone
+92 51 4509595
Email
yasirmajeed216@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Yaser Majeed
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Railway Carriage Factory Rd, Railway Scheme 7
City
Islamabad
Province
Punjab
Postal code
46000
Phone
+92 51 4509595
Email
yasirmajeed216@gmail.com
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
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
IPD collected for the primary outcome measure only
When the data will become available and for how long
After the publication of the study.
To whom data/document is available
academic institutions and researchers
Under which criteria data/document could be used
On informed request from the investigators
From where data/document is obtainable
by email
What processes are involved for a request to access data/document