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Treadmill Training With Kinesiotaping Affects Balance and Gait in Chronic Stroke Patients

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
treadmill training with KT group (TTKT group)
treadmill training without KT group (TT group)
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring balance, gait, kinesiotape, stroke

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: both male and females Age 30-50 years. duration of onset of stroke >6 months. Exclusion Criteria: • patients with orthopedic diseases(such as contracture) in the trunk and both lower extremities A history of other neurologic diseases or disorders (MS, Parkinsons). History of fall in last 6 months.' History of unstable CVS diseases high skin sensitivity or skin diseases lower extremity surgery or fracture, low back pain, or allergy to the KT.

Sites / Locations

  • Pakistan society of rehabilitation for disabled (PSRD)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

treadmill training with KT group (TTKT group)

treadmill training without KT group (TT group)

Arm Description

Participants will undergo treadmill training with kinesiotape applied on their trunk muscles/

Participants will undergo treadmill training.

Outcomes

Primary Outcome Measures

Berg Balance Scale (BBS):
The Berg Balance Scale (BBS) is a functional outcome measure in the International Classification of Functioning domain of activity, is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The BBS measures balance and functional mobility and has excellent reliability (0.99) and Interclass correlation coefficient 0.99 (0.98-0.99) .Berg balance scale scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. In general, Berg balance scale scores are interpreted as such: 0 to 20: A person with a score in this range will likely need the assistance of a wheelchair to move around safely. 21 to 40: A person with a score in this range will need some type of walking assistance, such as a cane or a walker. 41 to 56: A person with a score in this range is considered independent and should be able to move around safely without assistance. Changes from the baseline to 4th week
Dynamic gait index(DGI):
The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems.Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24.A score of less than 19 indicates a risk for falling. total duration of intervention is 4 weeks (baseline measurement will be taken on week 1 and postinterventional measurement will be taken on week 4)

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
May 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05878613
Brief Title
Treadmill Training With Kinesiotaping Affects Balance and Gait in Chronic Stroke Patients
Official Title
Effect of Treadmill Training With and Without Trunk Kinesiotaping on Balance and Gait in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to determine the effects of treadmill training with and without trunk kinesiotaping on balance and gait of chronic stroke patients. The main question it aims to answer is:- Does kinesiotaping have added benefit to improve gait and balance in chronic stroke patients?. Researcher will compare the treadmill training group with the group receiving treadmill training with kinesiotaping to see if there is any difference in the outcomes.
Detailed Description
Summary Stroke, one of the leading cause of death and disability worldwide, is defined as rapid deterioration of brain function due to disturbance in blood supply to the brain. According to the cause it is divided into two main types; ischemic stroke and hemorrhagic stroke. Stroke can lead to a number of physical impairments like muscle imbalance, impaired balance and postural control, poor voluntary control, body malalignment and disturbance of walking patterns etc. Ability to walk safely and participate in activities of daily living is the main goal of many individuals affected by stroke. Therefore, improving balance and gait is the primary focus of physical therapy interventions. Many therapeutic interventions such as , treadmill training, over ground gait training , Functional electrical stimulation, neurofacilitation approaches and strength training are used for improving balance and gait in patients affected by stroke, all of which have been proven to be beneficial. This study will be conducted to compare the effect of treadmill training with and without kinesiotaping on trunk muscles (rectus abdominis, erector spinae, external oblique and internal oblique) on gait and balance in chronic stroke patients. Many studies have shown that trunk muscles have a very important role in balance and gait in patients with stroke and KT application may be an effective intervention for trunk function and postural control however, there is no evidence on whether providing support to the trunk with kinesiotaping during treadmill training will have any added benefit on balance and gait or not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
balance, gait, kinesiotape, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treadmill training with KT group (TTKT group)
Arm Type
Experimental
Arm Description
Participants will undergo treadmill training with kinesiotape applied on their trunk muscles/
Arm Title
treadmill training without KT group (TT group)
Arm Type
Active Comparator
Arm Description
Participants will undergo treadmill training.
Intervention Type
Device
Intervention Name(s)
treadmill training with KT group (TTKT group)
Intervention Description
The area to be taped will be cleaned with an alcohol swab, and the I-shaped elastic KT was applied to the four trunk muscles from their insertion to their origin. Patients will then undergo treadmill walking with easy speed control for 20 minutes. The training will be immediately stopped if the subject complain of fatigue during treadmill training; training will be resumed after sufficient rest.
Intervention Type
Device
Intervention Name(s)
treadmill training without KT group (TT group)
Intervention Description
General treadmill training without taping will be carried out for the same time as the gait training of the experimental group, and the treadmill speed will also be a comfortable speed in the same manner as in the experimental group.
Primary Outcome Measure Information:
Title
Berg Balance Scale (BBS):
Description
The Berg Balance Scale (BBS) is a functional outcome measure in the International Classification of Functioning domain of activity, is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The BBS measures balance and functional mobility and has excellent reliability (0.99) and Interclass correlation coefficient 0.99 (0.98-0.99) .Berg balance scale scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. In general, Berg balance scale scores are interpreted as such: 0 to 20: A person with a score in this range will likely need the assistance of a wheelchair to move around safely. 21 to 40: A person with a score in this range will need some type of walking assistance, such as a cane or a walker. 41 to 56: A person with a score in this range is considered independent and should be able to move around safely without assistance. Changes from the baseline to 4th week
Time Frame
4th week
Title
Dynamic gait index(DGI):
Description
The DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems.Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24.A score of less than 19 indicates a risk for falling. total duration of intervention is 4 weeks (baseline measurement will be taken on week 1 and postinterventional measurement will be taken on week 4)
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: both male and females Age 30-50 years. duration of onset of stroke >6 months. Exclusion Criteria: • patients with orthopedic diseases(such as contracture) in the trunk and both lower extremities A history of other neurologic diseases or disorders (MS, Parkinsons). History of fall in last 6 months.' History of unstable CVS diseases high skin sensitivity or skin diseases lower extremity surgery or fracture, low back pain, or allergy to the KT.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wajiha Shahid, PhD
Phone
03214885079
Email
wajiha.shahid@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wajiha Shahid, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan society of rehabilitation for disabled (PSRD)
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wajiha Shahid, PhD
Phone
03214885079
Email
wajiha.shahid@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Maira Pervez, MSNMPT*

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27630439
Citation
Lee YJ, Kim JY, Kim SY, Kim KH. The effects of trunk kinesio taping on balance ability and gait function in stroke patients. J Phys Ther Sci. 2016 Aug;28(8):2385-8. doi: 10.1589/jpts.28.2385. Epub 2016 Aug 31.
Results Reference
background
PubMed Identifier
35425677
Citation
Rupasinghe CD, Ammar Bokhari S, Lutfi I, Noureen M, Islam F, Khan M, Amin F, Muthanna FMS. Frequency of Stroke and Factors Associated With It Among Old Age Hypertensive Patients in Karachi, Pakistan: A Cross-Sectional Study. Cureus. 2022 Mar 13;14(3):e23123. doi: 10.7759/cureus.23123. eCollection 2022 Mar.
Results Reference
background
PubMed Identifier
28687056
Citation
Tally Z, Boetefuer L, Kauk C, Perez G, Schrand L, Hoder J. The efficacy of treadmill training on balance dysfunction in individuals with chronic stroke: a systematic review. Top Stroke Rehabil. 2017 Oct;24(7):539-546. doi: 10.1080/10749357.2017.1345445. Epub 2017 Jul 7.
Results Reference
background
PubMed Identifier
23129815
Citation
Cho HY, Kim JS, Lee GC. Effects of motor imagery training on balance and gait abilities in post-stroke patients: a randomized controlled trial. Clin Rehabil. 2013 Aug;27(8):675-80. doi: 10.1177/0269215512464702. Epub 2012 Nov 5.
Results Reference
background
PubMed Identifier
23877032
Citation
Hendrickson J, Patterson KK, Inness EL, McIlroy WE, Mansfield A. Relationship between asymmetry of quiet standing balance control and walking post-stroke. Gait Posture. 2014 Jan;39(1):177-81. doi: 10.1016/j.gaitpost.2013.06.022. Epub 2013 Jul 19.
Results Reference
background
PubMed Identifier
36079092
Citation
Aprile I, Conte C, Cruciani A, Pecchioli C, Castelli L, Insalaco S, Germanotta M, Iacovelli C. Efficacy of Robot-Assisted Gait Training Combined with Robotic Balance Training in Subacute Stroke Patients: A Randomized Clinical Trial. J Clin Med. 2022 Aug 31;11(17):5162. doi: 10.3390/jcm11175162.
Results Reference
background
PubMed Identifier
26547547
Citation
Beyaert C, Vasa R, Frykberg GE. Gait post-stroke: Pathophysiology and rehabilitation strategies. Neurophysiol Clin. 2015 Nov;45(4-5):335-55. doi: 10.1016/j.neucli.2015.09.005. Epub 2015 Nov 4.
Results Reference
background
PubMed Identifier
30067555
Citation
Kim BR, Kang TW. The effects of proprioceptive neuromuscular facilitation lower-leg taping and treadmill training on mobility in patients with stroke. Int J Rehabil Res. 2018 Dec;41(4):343-348. doi: 10.1097/MRR.0000000000000309.
Results Reference
background
PubMed Identifier
25435710
Citation
Kim WI, Choi YK, Lee JH, Park YH. The effect of muscle facilitation using kinesio taping on walking and balance of stroke patients. J Phys Ther Sci. 2014 Nov;26(11):1831-4. doi: 10.1589/jpts.26.1831. Epub 2014 Nov 13.
Results Reference
background
PubMed Identifier
33177223
Citation
Dai S, Piscicelli C, Clarac E, Baciu M, Hommel M, Perennou D. Balance, Lateropulsion, and Gait Disorders in Subacute Stroke. Neurology. 2021 Apr 27;96(17):e2147-e2159. doi: 10.1212/WNL.0000000000011152. Epub 2020 Nov 11.
Results Reference
background

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Treadmill Training With Kinesiotaping Affects Balance and Gait in Chronic Stroke Patients

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