Chronic StrokeNCT05526859
Effect of Kinesiotape Technique on Wrist Among Chronic Stroke Patients
A study testing Kinsiotaping for wrist flexor muscles and Kinesiotaping for wrist extensor muscles in people with Chronic Stroke, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.
Trial summary
The aim of this randomized controlled is to assess the effect of kinesiotape technique upon wrist joint among the patients with chronic stroke. Patients are devided into groups, in group A kinesiotaping facilitation technique is applied on wrist extensor muscles while inhibition technique is applied on wrist flexor… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Kinsiotaping for wrist flexor muscles and Kinesiotaping for wrist extensor muscles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 31 Aug 2022to 26 Oct 2022
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age b/w 40 to 90
- Limited ROM (wrist extension)
Who cannot join
- Disoriented
- Who needs more then moderate support to achieve basic ADL and are bed bound
- Communication gap
- Allergic to Kinesiotaping after being positive to patch test
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shifa Tameer-e-Millat University
Islamabad, Fedral, 44000
Syed Ali Hussain, PhD*, +923315191713, alihussain_dpt.ahs@stmu.edu.pk
Nouman Khan, MSPT, +923339378324, nouman_drs.ahs@stmu.edu.pk
About this study
Official title: Effect of Wrist Flexors Inhibition in Comparison to Wrist Extensors Facilitation Through Kinesiotaping Technique in Chronic Hemiplegic Stroke Patients With Limited Wrist Extension
The aim of this randomized controlled is to assess the effect of kinesiotape technique upon wrist joint among the patients with chronic stroke. Patients are devided into groups, in group A kinesiotaping facilitation technique is applied on wrist extensor muscles while inhibition technique is applied on wrist flexor muscles and the result is the compared between the groups and within the group.
Read the detailed description
Stroke is a very common disease worldwide causing severe musculoskeletal disability due to which quality of life of patient compromises, patient becomes dependent of assistance in daily living activities and few becomes bed ridden. Stroke also causes death of the patient. Apart from musculoskeletal issues patient's cognitive abilities are also effected. It is tough to manage these patients as stroke varies in types and symptoms. Symptoms and severity depend upon type of stroke and factors like lifestyle, age and health issues. According to the symptoms different physiotherapy techniques and rehabilitation is used along with medical treatment and counseling of the patient. Kinesiotape also has the advantage that it can be worn 3-5 days due to which it's effects remains for long time as compare to other treatments which are given and has effect for a specific time for example a session of physical therapy including exercises is for an hour but this tape can be worn for days once applied.
Randomized controlled trial was done, 24 patients were recruited according to inclusion exclusion criteria. Patients were further divided into two groups; group 1 was given muscular facilitation treatment for wrist extensors and group 2 was given sessions for muscle inhibition treatment for wrist flexors. 6 sessions were given, 1 session per week over the period of 6 weeks to each patient.
Wrist range of motion for extension, flexion, ulnar and medial deviation was measured using goniometer before and after the 6 weeks. Manual muscle test for wrist extensors, modified ashworth scale and upper limb functional index scoring was done before and after sessions. Data was collected from a private clinic of PWD Rawalpindi.
The statistical values of result showed no significant change in between both the groups, before and after treatment. But a significant improvement was about observed within the group analysis It can be concluded from this study that Kinesiotape is an effective treatment method both in inhibiting and facilitating muscular performance. Hence both treatments were equally effective. it helps in increasing range of motion and in reducing spasticity.
- Conditions
- Chronic Stroke
- Being tested
- Kinsiotaping for wrist flexor muscles, Kinesiotaping for wrist extensor muscles
- Keywords
- Stroke, Manual Muscle testing, Kinesiotape, Range of Motion, Upper Extremity Functional Index, Modified Ashworth Scale
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinsiotaping for wrist flexor musclesOther
The flexor muscles of the wrist area will be targeted.
Kinesiotaping for wrist extensor musclesOther
The extensor muscles of the wrist area will be targeted.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Hyperactive muscle correction for wrist extensors: Kinesiotape was applied to facilitate wrist extensor muscles from proximal to distal with 15-35% tension in therapeutic zone and no tension at anchor and end. Receives: Other: Kinesiotaping for wrist extensor muscles |
| Group 2 | Experimental | Hypoactive muscle correction for wrist flexors: Wrist flexors muscles were inhibited by applying tape from distal to proximal with 15-25% tension in therapeutic zone and no tension at anchor and end. Receives: Other: Kinsiotaping for wrist flexor muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist extensors manual muscle test score
Wrist extensors strength was measured as baseline before the start of intervention and was compared with the measurement after 6 weeks of application of kinesiotape.
Measured: 6 weeks
Wrist ROMS through Goniometer
Wrist ROM was measured using universal goniometer, baseline values for wrist flexion, extension, ulnar deviation and medial deviation was measured and then compared to the values measured after 6 weeks of intervention.
Measured: 6 weeks
Spasticity through modified ashwoth scale
Wrist spasticity was measured through modified ashworth scale before the intervention and then was compared with the values taken after 6th week
Measured: 6 weeks
Upper extremity functional index (UEFI)
Patient was asked to perform different activities as opening the door and combing hair, score was done according to the difficulty level faced by patients while performing the activities. Measurement was taken before first session and was compared with the values taken after 6 weeks of intervention
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start31 Aug 2022
- Primary completion19 Oct 2022 (estimated)
- Study completion26 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- 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
- Model description
- Two group were taken and given treatment with the concern study protocols.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Tameer-e-Millat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouman Khan, Shifa Tameer-e-Millat University
- Investigators
- Saman Tauseef, MSPT, Principal investigator, Shifa Tameer-e-Millat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526859
- Sponsor's protocol ID
- Saman IRB00
- Status last verified
- Aug 2022
- First submitted
- 31 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akpalu J, Akpalu A, Ofei F. The metabolic syndrome among patients with cardiovascular disease in Accra, Ghana. Ghana Med J. 2011 Dec;45(4):161-6.
PubMed 22359422Anwar A, Saleem S, Aamir A, Diwan M. Organization of Stroke Care in Pakistan. Int J Stroke. 2020 Jul;15(5):565-566. doi: 10.1177/1747493019879663. Epub 2019 Sep 30.
PubMed 31564238Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed definitions and a shared vision for new standards in stroke recovery research: The Stroke Recovery and Rehabilitation Roundtable taskforce. Int J Stroke. 2017 Jul;12(5):444-450. doi: 10.1177/1747493017711816.
PubMed 28697708Cramer SC. Repairing the human brain after stroke: I. Mechanisms of spontaneous recovery. Ann Neurol. 2008 Mar;63(3):272-87. doi: 10.1002/ana.21393.
PubMed 18383072Drouin JL, McAlpine CT, Primak KA, Kissel J. The effects of kinesiotape on athletic-based performance outcomes in healthy, active individuals: a literature synthesis. J Can Chiropr Assoc. 2013 Dec;57(4):356-65.
PubMed 24302784Huang YC, Chang KH, Liou TH, Cheng CW, Lin LF, Huang SW. Effects of Kinesio taping for stroke patients with hemiplegic shoulder pain: A double-blind, randomized, placebo-controlled study. J Rehabil Med. 2017 Mar 6;49(3):208-215. doi: 10.2340/16501977-2197.
PubMed 28233009Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.
PubMed 12907818Naci B, Ozyilmaz S, Aygutalp N, Demir R, Baltaci G, Yigit Z. Effects of Kinesio Taping and compression stockings on pain, edema, functional capacity and quality of life in patients with chronic venous disease: a randomized controlled trial. Clin Rehabil. 2020 Jun;34(6):783-793. doi: 10.1177/0269215520916851. Epub 2020 Apr 29.
PubMed 32349528Nishimura Y, Onoe H, Morichika Y, Perfiliev S, Tsukada H, Isa T. Time-dependent central compensatory mechanisms of finger dexterity after spinal cord injury. Science. 2007 Nov 16;318(5853):1150-5. doi: 10.1126/science.1147243.
PubMed 18006750
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Wrist Flexors Inhibition in Comparison to Wrist Extensors Facilitation Through Kinesiotaping Technique in Chronic Hemiplegic Stroke Patients With Limited Wrist Extension
- ClinicalTrials.gov ID
- NCT05526859
- Acronym / sponsor ID
- Saman IRB00
- Conditions
- Chronic Stroke
- Keywords
- Stroke, Manual Muscle testing, Kinesiotape, Range of Motion, Upper Extremity Functional Index, Modified Ashworth Scale
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shifa Tameer-e-Millat UniversityUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 19 Oct 2022 (estimated)
- Study completion
- 26 Oct 2022 (estimated)
- First posted
- 2 Sep 2022 (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 aim of this randomized controlled is to assess the effect of kinesiotape technique upon wrist joint among the patients with chronic stroke. Patients are devided into groups, in group A kinesiotaping facilitation technique is applied on wrist extensor muscles while inhibition technique is applied on wrist flexor muscles and the result is the compared between the groups and within the group.
Detailed description
Stroke is a very common disease worldwide causing severe musculoskeletal disability due to which quality of life of patient compromises, patient becomes dependent of assistance in daily living activities and few becomes bed ridden. Stroke also causes death of the patient. Apart from musculoskeletal issues patient's cognitive abilities are also effected. It is tough to manage these patients as stroke varies in types and symptoms. Symptoms and severity depend upon type of stroke and factors like lifestyle, age and health issues. According to the symptoms different physiotherapy techniques and rehabilitation is used along with medical treatment and counseling of the patient. Kinesiotape also has the advantage that it can be worn 3-5 days due to which it's effects remains for long time as compare to other treatments which are given and has effect for a specific time for example a session of physical therapy including exercises is for an hour but this tape can be worn for days once applied.
Randomized controlled trial was done, 24 patients were recruited according to inclusion exclusion criteria. Patients were further divided into two groups; group 1 was given muscular facilitation treatment for wrist extensors and group 2 was given sessions for muscle inhibition treatment for wrist flexors. 6 sessions were given, 1 session per week over the period of 6 weeks to each patient.
Wrist range of motion for extension, flexion, ulnar and medial deviation was measured using goniometer before and after the 6 weeks. Manual muscle test for wrist extensors, modified ashworth scale and upper limb functional index scoring was done before and after sessions. Data was collected from a private clinic of PWD Rawalpindi.
The statistical values of result showed no significant change in between both the groups, before and after treatment. But a significant improvement was about observed within the group analysis It can be concluded from this study that Kinesiotape is an effective treatment method both in inhibiting and facilitating muscular performance. Hence both treatments were equally effective. it helps in increasing range of motion and in reducing spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two group were taken and given treatment with the concern study protocols.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Kinesiotaping for wrist extensor musclesHyperactive muscle correction for wrist extensors: Kinesiotape was applied to facilitate wrist extensor muscles from proximal to distal with 15-35% tension in therapeutic zone and no tension at anchor and end. |
| Group 2 | Experimental | Other: Kinsiotaping for wrist flexor musclesHypoactive muscle correction for wrist flexors: Wrist flexors muscles were inhibited by applying tape from distal to proximal with 15-25% tension in therapeutic zone and no tension at anchor and end. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age b/w 40 to 90
- Limited ROM (wrist extension)
Key exclusion criteria (4 listed)
- Disoriented
- Who needs more then moderate support to achieve basic ADL and are bed bound
- Communication gap
- Allergic to Kinesiotaping after being positive to patch test
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 |
|---|---|---|
| Kinsiotaping for wrist flexor musclesThe flexor muscles of the wrist area will be targeted. | Other | Group 2 |
| Kinesiotaping for wrist extensor musclesThe extensor muscles of the wrist area will be targeted. | Other | Group 1 |
Primary outcome
Wrist extensors manual muscle test score
Time frame: 6 weeks
Wrist extensors strength was measured as baseline before the start of intervention and was compared with the measurement after 6 weeks of application of kinesiotape.
Wrist ROMS through Goniometer
Time frame: 6 weeks
Wrist ROM was measured using universal goniometer, baseline values for wrist flexion, extension, ulnar deviation and medial deviation was measured and then compared to the values measured after 6 weeks of intervention.
Spasticity through modified ashwoth scale
Time frame: 6 weeks
Wrist spasticity was measured through modified ashworth scale before the intervention and then was compared with the values taken after 6th week
Upper extremity functional index (UEFI)
Time frame: 6 weeks
Patient was asked to perform different activities as opening the door and combing hair, score was done according to the difficulty level faced by patients while performing the activities. Measurement was taken before first session and was compared with the values taken after 6 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Background: PubMed 22359422Akpalu J, Akpalu A, Ofei F. The metabolic syndrome among patients with cardiovascular disease in Accra, Ghana. Ghana Med J. 2011 Dec;45(4):161-6.
- Background: PubMed 31564238Anwar A, Saleem S, Aamir A, Diwan M. Organization of Stroke Care in Pakistan. Int J Stroke. 2020 Jul;15(5):565-566. doi: 10.1177/1747493019879663. Epub 2019 Sep 30.
- Background: PubMed 28697708Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed definitions and a shared vision for new standards in stroke recovery research: The Stroke Recovery and Rehabilitation Roundtable taskforce. Int J Stroke. 2017 Jul;12(5):444-450. doi: 10.1177/1747493017711816.
- Background: PubMed 18383072Cramer SC. Repairing the human brain after stroke: I. Mechanisms of spontaneous recovery. Ann Neurol. 2008 Mar;63(3):272-87. doi: 10.1002/ana.21393.
- Background: PubMed 24302784Drouin JL, McAlpine CT, Primak KA, Kissel J. The effects of kinesiotape on athletic-based performance outcomes in healthy, active individuals: a literature synthesis. J Can Chiropr Assoc. 2013 Dec;57(4):356-65.
- Background: PubMed 28233009Huang YC, Chang KH, Liou TH, Cheng CW, Lin LF, Huang SW. Effects of Kinesio taping for stroke patients with hemiplegic shoulder pain: A double-blind, randomized, placebo-controlled study. J Rehabil Med. 2017 Mar 6;49(3):208-215. doi: 10.2340/16501977-2197.
- Background: PubMed 12907818Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.
- Background: PubMed 32349528Naci B, Ozyilmaz S, Aygutalp N, Demir R, Baltaci G, Yigit Z. Effects of Kinesio Taping and compression stockings on pain, edema, functional capacity and quality of life in patients with chronic venous disease: a randomized controlled trial. Clin Rehabil. 2020 Jun;34(6):783-793. doi: 10.1177/0269215520916851. Epub 2020 Apr 29.
- Background: PubMed 18006750Nishimura Y, Onoe H, Morichika Y, Perfiliev S, Tsukada H, Isa T. Time-dependent central compensatory mechanisms of finger dexterity after spinal cord injury. Science. 2007 Nov 16;318(5853):1150-5. doi: 10.1126/science.1147243.
- 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.
Saman Tauseef, MSPT principal investigator
Shifa Tameer-e-Millat 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 Kinsiotaping for wrist flexor muscles and Kinesiotaping for wrist extensor muscles in people with Chronic Stroke, run by Shifa Tameer-e-Millat 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 2 inclusion and 4 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 2 Sep 2022. 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 Dr. Syed Ali Hussain, Phd* (+923315191713, alihussain_dpt.ahs@stmu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist extensors manual muscle test score (time frame: 6 weeks). The study lists 4 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 NCT05526859, which also lists 9 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 2 Sep 2022.