1.To assess the effect of taping with balance training on mobility and balance in participants with stroke. 2.To assess the effect of balance training on mobility and balance in participants with stroke. 3.To compare effect of taping with and without using balance training on mobility and balance in participants with stroke.
Design
Randomized Control Trial (RCT) Single blind study.
Settings and conduct
Pakistan Institute of Medical Sciences Islamabad. Physiotherapy department.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participants of both genders with age more than 35 year will be enrolled. Participants those with hemiparesis with onset more than three months of stroke onset and less than one and a half year. A score of 24 or higher on the MMSE, those who can walk more than 10 m independently with or without a walking aid. Those who are having spastic paralysis of lower limb, those who understand the purpose of the study and provided written consent form.
Exclusion Criteria: Participant those with a history of surgery on the lower extremities. High skin sensitivity or skin diseases. Those who complained of pain during dorsiflexion of the ankle joint, and those with a modified Ashworth Scale >2.
Intervention groups
There are two interventional group 1. Experimental group (A) Balance training with taping group and 2) Control group (B) Balance training without taping group.
Main outcome variables
Ten meter walk test, Berg Balance Scale, Timed up and go test, Six Minute Walk Test,
Self structured Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211022052835N7
Registration date:2023-05-03, 1402/02/13
Registration timing:prospective
Last update:2023-05-03, 1402/02/13
Update count:0
Registration date
2023-05-03, 1402/02/13
Registrant information
Name
Fouzia Batool
Name of organization / entity
Shifa Tameer-e-Millat University
Country
Pakistan
Phone
+92 51 8441752
Email address
fouzia_dpt.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-08, 1402/02/18
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study to assess the effect of balance training with and without taping on mobility and balance in stroke patients
Public title
A comparative study to assess the effect of balance training with and without taping on mobility and balance in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participants of both genders with age more than 35 year will be enrolled.
Participants those with hemiparesis with onset more than three months of stroke onset and less than one and a half year.
A score of 24 or higher on the MMSE, those who can walk more than 10 m independently with or without a walking aid.
Those who are having spastic paralysis of lower limb, those who understand the purpose of the study and provided written consent form.
Exclusion criteria:
Participant those with a history of surgery on the lower extremities.
High skin sensitivity or skin diseases.
Those who complained of pain during dorsiflexion of the ankle joint, and those with a modified Ashworth Scale >2.
Age
From 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The sequence of random allocation is done by an individual who has not directly involved in the study. Random numbers is written on index cards and placed in thick and opaque sealed envelops before the study. After taking consent from the participants for their participation in the study, the therapist opens the envelop and give the respective protocol to the individual. The study is single blinded as participants is not aware of the intervention group they are placed in. Participants will be placed either in to the experimental group 1 (Balance training with taping) or control group 2 (Balance training without taping) keeping the process completely randomized ,sealed envelope method will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
Prior to collecting data, participants would be informed about both the treatment techniques used in both groups; experimental group A (Balance training with taping) and control group B (Balance training without taping). Further they are informed that you will get one of these treatment depending upon the group written on the card inside the envelop you choose. The group A or B belongs to which way of treatment is known to therapist but the patient doesn't know about it.
Placebo
Not used
Assignment
Parallel
Other design features
N/A
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional review board and ethical committee and ethical committee of shifa tameer-e-millat univ
Street address
Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad
City
Islamabad
Postal code
44000
Approval date
2023-04-04, 1402/01/15
Ethics committee reference number
IRB#018-23
Health conditions studied
1
Description of health condition studied
Hemiparesis
ICD-10 code
G46
ICD-10 code description
G46
Primary outcomes
1
Description
Balance
Timepoint
Pre intervention at 0-week, and Post Intervention data after 4 weeks will be taken.
Method of measurement
Ten meter walk test, Berg Balance Scale, Timed up and go test, Six Minute Walk Test
2
Description
• Mobility
Timepoint
Pre intervention at 0-week, and Post Intervention data after 4 weeks will be taken.
Method of measurement
Ten meter walk test, Berg Balance Scale, Timed up and go test, Six Minute Walk Test
Secondary outcomes
1
Description
To compare the effect of balance training with and without taping on mobility and balance in stroke patients.
Timepoint
Pre Intervention at 0 week, and Post Intervention data after 4 weeks will be taken.
Method of measurement
Ten meter walk test, Berg Balance Scale, Timed up and go test, Six Minute Walk Test
Intervention groups
1
Description
Intervention Group A: Group A would receive Balance training with taping. There would be 3 sessions per week for 4 weeks. Session would be comprised of 20 minutes with 5 minutes of warm and 5 minutes of cool down before and after the session. Experimental group (taping group), for taping with balance training, kinesio tape will be used for ankle taping. Kinesio tape is used to stabilize the ankle joint during static standing or walking in stroke patients. In this study, the tape will be attached to the peroneus tertius, peroneus longus, tibialis anterior, and extensor hallucis longus, which are used widely for ankle joint stability in stroke patients. With kinesio tape attached to the four muscles, each participant will be given balance training for 20 minutes. Balance training plan: (1) 5 minutes warm-up, (2) 10 minutes static balance exercises, such as Squats (two leg stance), One leg stance, (3) 10 minutes dynamic balance exercises, such as Jogging end to end, Sideways walking or running with crossovers, Forward walking or running in a zigzag line, Backward walking or running in a zigzag line, and (4) 5 minutes of cool-down.
Category
Rehabilitation
2
Description
Intervention Group B: Group B would receive Balance training without taping. There would be 3 sessions per week for 4 weeks. Session would be comprised of 20 minutes with 5 minutes of warm and 5 minutes of cool down before and after the session. Balance training plan: (1) 5 minutes warm-up, (2) 10 minutes static balance exercises, such as Squats (two leg stance), One leg stance, (3) 10 minutes dynamic balance exercises, such as Jogging end to end, Sideways walking or running with crossovers, Forward walking or running in a zigzag line, Backward walking or running in a zigzag line, and (4) 5 minutes of cool-down. These are traditional balance exercise. The treatment duration for the control group will be 20 minutes/3 times a week for 4 weeks.