StrokeNCT05878613
Treadmill Training With Kinesiotaping Affects Balance and Gait in Chronic Stroke Patients
A study testing treadmill training with KT group (TTKT group) and treadmill training without KT group (TT group) in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial 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?. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Stroke
- What is being tested?
- treadmill training with KT group (TTKT group) and treadmill training without KT group (TT group)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- both male and females
- Age 30-50 years.
- duration of onset of stroke >6 months.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan society of rehabilitation for disabled (PSRD)
Lahore, Punjab Province
Wajiha Shahid, PhD, 03214885079, wajiha.shahid@riphah.edu.pk
Maira Pervez, MSNMPT*
About this study
Official title: Effect of Treadmill Training With and Without Trunk Kinesiotaping on Balance and Gait in Chronic Stroke Patients
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- treadmill training with KT group (TTKT group), treadmill training without KT group (TT group)
- Keywords
- balance, gait, kinesiotape, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
| Study group | Role | What they receive |
|---|---|---|
| treadmill training with KT group (TTKT group) | Experimental | Participants will undergo treadmill training with kinesiotape applied on their trunk muscles/ Receives: Device: treadmill training with KT group (TTKT group) |
| treadmill training without KT group (TT group) | Active comparator | Participants will undergo treadmill training. Receives: Device: treadmill training without KT group (TT group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Apr 2023
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajiha Shahid, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878613
- Sponsor's protocol ID
- REC/RCR & AHS/23/0206
- Status last verified
- May 2023
- First submitted
- 18 Apr 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27630439Rupasinghe 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.
PubMed 35425677Tally 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.
PubMed 28687056Cho 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.
PubMed 23129815Hendrickson 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.
PubMed 23877032Aprile 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.
PubMed 36079092Beyaert 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.
PubMed 26547547Kim 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.
PubMed 30067555Kim 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.
PubMed 25435710Dai 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.
PubMed 33177223
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treadmill Training With and Without Trunk Kinesiotaping on Balance and Gait in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05878613
- Acronym / sponsor ID
- REC/RCR & AHS/23/0206
- Conditions
- Stroke
- Keywords
- balance, gait, kinesiotape, stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treadmill training with KT group (TTKT group) | Experimental | Device: treadmill training with KT group (TTKT group)Participants will undergo treadmill training with kinesiotape applied on their trunk muscles/ |
| treadmill training without KT group (TT group) | Active comparator | Device: treadmill training without KT group (TT group)Participants will undergo treadmill training. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- both male and females
- Age 30-50 years.
- duration of onset of stroke >6 months.
Key exclusion criteria (6 listed)
- • patients with orthopedic diseases(such as contracture) in the trunk and both lower extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treadmill training with KT group (TTKT group)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. | Device | treadmill training with KT group (TTKT group) |
| treadmill training without KT group (TT group)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. | Device | treadmill training without KT group (TT group) |
Primary outcome
Berg Balance Scale (BBS):
Time frame: 4th week
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):
Time frame: 4th week
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Background: PubMed 27630439Lee 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.
- Background: PubMed 35425677Rupasinghe 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.
- Background: PubMed 28687056Tally 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.
- Background: PubMed 23129815Cho 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.
- Background: PubMed 23877032Hendrickson 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.
- Background: PubMed 36079092Aprile 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.
- Background: PubMed 26547547Beyaert 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.
- Background: PubMed 30067555Kim 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.
- Background: PubMed 25435710Kim 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.
- Background: PubMed 33177223Dai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wajiha Shahid, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treadmill training with KT group (TTKT group) and treadmill training without KT group (TT group) in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wajiha Shahid, PhD (03214885079, wajiha.shahid@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS): (time frame: 4th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05878613, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.