To determine the effectiveness of gaze stability with and without vestibular rehabilitation on gait, balance, and kinesiophobia in elderly people.
Design
A concealed, randomized, single-blinded, controlled trialS with a group design of 96 participants.
Settings and conduct
In Sofia old age home Multan and Nova old age home Multan study will be conducted. Group-A will be treated with gaze stability exercises and Group B will be treated with gaze stability with vestibular rehabilitation exercises. The data analyzer will be kept blind.
Participants/Inclusion and exclusion criteria
In inclusion criteria both gender aged 50-79 years with at least 50% of Activities-specific Balance Confidence Scale score included. In exclusion criteria were people with serious mobility issues, people with the neoplastic disorder, and coronary artery disease patients.
Intervention groups
Group A received gaze stability exercises and group B received gaze stability with vestibular rehabilitation exercises.
Main outcome variables
Tampa scale for kinesiophobia (TSK)
Time up and go test for balance (TUG)
Dynamic gait index for gait (DGI)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220617055200N1
Registration date:2022-06-23, 1401/04/02
Registration timing:retrospective
Last update:2022-06-23, 1401/04/02
Update count:0
Registration date
2022-06-23, 1401/04/02
Registrant information
Name
Iqra Aslam
Name of organization / entity
ALI-UL-MURTAZA, DEPARTMENT OF REHABILITATION SCIENCES, MUHAMMAD INSTITUTE OF MEDICAL AND ALLIED SCIE
Country
Pakistan
Phone
+92 337 0731261
Email address
iqraaslam@mimas.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-15, 1400/08/24
Expected recruitment end date
2021-12-15, 1400/09/24
Actual recruitment start date
2021-11-15, 1400/08/24
Actual recruitment end date
2021-12-20, 1400/09/29
Trial completion date
2022-07-20, 1401/04/29
Scientific title
EFFECTIVENESS OF GAZE STABILITY WITH AND WITHOUT VESTIBULAR REHABILITATION ON GAIT, BALANCE, AND KINESIOPHOBIA IN ELDERLY PEOPLE
Public title
Effects of exercises on balance, gait, and kinesiophobia in elderly people
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both gender
Age 50-79 years
At least 50% of activities-specific Balance Confidence Scale
Exclusion criteria:
Disabled individuals were left out of the loop
Those who had serious mobility issues were not included
People who needed a walker or cane to get about were not included
Coronary artery disease patients were not included
Age
From 50 years old to 79 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
96
More than 1 sample in each individual
Number of samples in each individual:
2
Before and after treatment
Actual sample size reached:
96
More than 1 sample in each individual
Actual sample size in each individual:
48
Before and after treatment
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation concealment occurs and patients will be recruited by using simple randomization through the lottery method. The lottery method is carried out through sealed envelopes. each participant will randomly choose the sealed envelopes and open this sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer was unaware of the results. The data analyzer was unaware of the treatments received by group A and group B. Data analyzer was unaware of the results.
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institiutional ethcal committee of Muhammad institute of medical and allied sciences
Street address
HBL street near Sabzazar metro station Bosan road Multan
City
Multan
Postal code
60700
Approval date
2021-11-27, 1400/09/06
Ethics committee reference number
2021/IRB/13/PT/19
Health conditions studied
1
Description of health condition studied
Gait imbalance
ICD-10 code
R26.89
ICD-10 code description
Other abnormalities of gait and mobility
Primary outcomes
1
Description
Balance
Timepoint
evaluated pre treatment and post treatment
Method of measurement
time up and go test
2
Description
gait training
Timepoint
evaluated pre treatment and post treatment
Method of measurement
Dynamic gait index
3
Description
kinesiophobia
Timepoint
evaluated pre treatment and post treatment
Method of measurement
Tampa scale for kineseophobia
Secondary outcomes
1
Description
ADLs
Timepoint
evaluated pre treatment and post treatment
Method of measurement
time up and go test, gait training index
Intervention groups
1
Description
Intervention group: Group-B will be treated with Gaze stability with vestibular rehabilitation exercises. A Warm-Up Exercise For 5 minutes Before the Activity Is Included As Short Walks with Normal Speed and Games with Medicine Balls, Using Hands and Feet. For Gaze Stabilization Exercise the Participants Will Make to Sit Facing a Blank Wall and Hold Out Their Thumb Straight in Front of The Therapist. Participants will be Requested to Maintain Their Eyes Fixated on Your Thumb at All Times During This Exercise, Then Turn Their Head a Little to The Right and Then to The Left. Alternate Turning from Left to Right and Back in A Rhythmic Pattern. The Transition from Left to Right Took About a Second and Went Nicely. This will be repeated 10 times. Vestibular rehabilitation exercises formed both in sitting and standing. Walked outside (moved forward, backward, and sideways at various speeds). Stand on a single-leg stance & double leg stance. Several types of ground surfaces were included like foam rubber and mattresses. All activities will be performed with eyes open & eyes closed. Each position allowed holding for 10 seconds. Duration is 12 weeks 3 days a week.
Category
Treatment - Other
2
Description
Control group: Group-A will be treated with Gaze stability. A Warm-Up Exercise For 5 minutes Before the Activity Is Included As Short Walks with Normal Speed and Games with Medicine Balls, Using Hands and Feet. For Gaze Stabilization Exercise the Participants Will Make to Sit Facing a Blank Wall and Hold Out Their Thumb Straight in Front of The Therapist. Participants will be Requested to Maintain Their Eyes Fixated on Your Thumb at All Times During This Exercise, Then Turn Their Head a Little to The Right and Then to The Left. Alternate Turning from Left to Right and Back in A Rhythmic Pattern. The Transition from Left to Right Took About a Second and Went Nicely. Duration is 12 weeks 3 days a week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Edhi old age home
Full name of responsible person
Nimra Arif
Street address
Multan
City
Multan
Postal code
60700
Phone
+92 337 0731261
Email
angelnimra95@gmail.com
Web page address
http://mimas.edu.pk/
2
Recruitment center
Name of recruitment center
Nova old age home
Full name of responsible person
Nimra Arif
Street address
Multan
City
Multan
Postal code
60700
Phone
+92 337 0731261
Email
angelnimra95@gmail.com
Web page address
http://mimas.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Muhammad institute of medical and allied sciences Multan
Full name of responsible person
Nimra Arif
Street address
HBL street near sabzazar metro station, Multan.
City
Multan
Postal code
60700
Phone
+92 333 3877032
Email
angelnimra95@gmail.com
Web page address
http://mimas.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad institute of medical and allied sciences Multan
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
Muhammad institute of medical and allied sciences, Multan.
Full name of responsible person
Nimra Arif
Position
senior Lecturer
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
HBL Street near sabzazar metro station Multan
City
Multan
Province
punjab
Postal code
60700
Phone
+92 333 3877032
Email
angelnimra95@gmail.com
Web page address
http://mimas.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Muhammad institute of medical and allied sciences, Multan.
Full name of responsible person
Imran Ahmad Khan
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Cardiology
Street address
HBL street near sabzazar metro station, Multan.
City
Multan
Province
Punjab
Postal code
60700
Phone
+92 333 6120602
Email
imranahmadkhandurrani@gmail.com
Web page address
http://mimas.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
Muhammad institute of medical and allied sciences, Multan
Full name of responsible person
Nimra Arif
Position
Senior lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
HBL street near sabzazar metro station Multan
City
Multan
Province
punjab
Postal code
60700
Phone
+92 333 3877032
Email
angelnimra95@gmail.com
Web page address
http://mimas.edu.pk/
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