NCT05878613

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

April 18, 2023

Last Update Submit

May 18, 2023

Conditions

Stroke

Keywords

balancegaitkinesiotapestroke

Outcome Measures

Primary Outcomes (2)

  • 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

    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)

    4th week

Study Arms (2)

treadmill training with KT group (TTKT group)

EXPERIMENTAL

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

Device: treadmill training with KT group (TTKT group)

treadmill training without KT group (TT group)

ACTIVE COMPARATOR

Participants will undergo treadmill training.

Device: treadmill training without KT group (TT group)

Interventions

treadmill training with KT group (TTKT group)DEVICE

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.

treadmill training with KT group (TTKT group)
treadmill training without KT group (TT group)DEVICE

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.

treadmill training without KT group (TT group)

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • both male and females
  • Age 30-50 years.
  • duration of onset of stroke \>6 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan society of rehabilitation for disabled (PSRD)

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (10)

  • 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.

    PMID: 27630439BACKGROUND

  • 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.

    PMID: 35425677BACKGROUND

  • 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.

    PMID: 28687056BACKGROUND

  • 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.

    PMID: 23129815BACKGROUND

  • 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.

    PMID: 23877032BACKGROUND

  • 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.

    PMID: 36079092BACKGROUND

  • 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.

    PMID: 26547547BACKGROUND

  • 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.

    PMID: 30067555BACKGROUND

  • 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.

    PMID: 25435710BACKGROUND

  • 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.

    PMID: 33177223BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Wajiha Shahid, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wajiha Shahid, PhD

CONTACT

03214885079wajiha.shahid@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 26, 2023

Study Start

April 1, 2023

Primary Completion

July 30, 2023

Study Completion

August 30, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)