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StrokeNCT05857657

Immediate Effects of PNF With Lower Leg Kinesio Taping in Chronic Stroke

A study testing : lower leg kinesiotaping, propriocepticve neuromuscular facilitation and propriocepticve neuromuscular facilitation with lower leg kinesiotaping in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this research is to find the immediate effects of propriocepticve neuromuscular facilitation with lower leg kinesiotaping on ankle dorsiflexion, gait and functional mobility in patients with chronic stroke. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Stroke
What is being tested?
: lower leg kinesiotaping, propriocepticve neuromuscular facilitation and propriocepticve neuromuscular facilitation with lower leg kinesiotaping
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
5 Mar 2023to 15 Dec 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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with hemiplegia due to hemorrhagic or ischemic stroke for more than 6 months
  • Able to walk independently for over 10 m without assistive device
  • Ability to comprehend simple instructions(Mini-Mental State Examination (MMSE) score above 24)
  • Insufficient ankle dorsiflexion during the swing phase of the gait cycle and less than 8 degree of ankle dorsiflexion range of motion on the affected side during gait

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Riphah Rehabilitation center

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Immediate Effects of Proprioceptive Neuromuscular Facilitation With Lower Leg Kinesiotaping on Ankle Dorsiflexion, Gait and Functional Mobility in Patients With Chronic Stroke

The aim of this research is to find the immediate effects of propriocepticve neuromuscular facilitation with lower leg kinesiotaping on ankle dorsiflexion, gait and functional mobility in patients with chronic stroke. It will be a randomized clinical trial in which participants will be selected through non probability convenience sampling. Patients aged range from 40 to 70 years, both gender, diagnosed with hemiplegia due to hemorrhagic or ischemic stroke for more than 6 months, with insufficient ankle dorsi flexion less than 8 degree will be included in this study whereas patients with neurological problems other than stroke that would interfere with gait and balance control and with limbs affected bilaterally will be excluded from study. Participant will be randomly allocated into three groups (A,B and C). Group A will receive only ankle kinesiotaping that will be applied for 30 minutes for one session. Group B will receive proprioceptive neuromuscular facilitation hold-relax technique in flexion-adduction-external rotation pattern, 15-20 repetitions that will be applied in lying position for 10-15 minutes for one session.

Group C will receive both proprioceptive neuromuscular facilitation hold-relax technique with ankle kinesiotaping. Posttest measurement will be taken after 30 minutes of one session of treatment using Time up and GO (TUG) test, dynamic gait index, barthel index and Motor Assessment Scale . Data will be analyzed by SPSS version 21

Read the detailed description

Detailed Description: Stroke has been described clinically through the abrupt onset of signs of focal neurological disorder that remain more than 24 hours( or lead to earlier brain damage) and are due to acute vascular damage to part of the brain.The general prevalence charge of stroke is round 2-25 according to thousand population. The chance of recurrance over five years is 15-40%. Ischemic stroke is a type of stroke that occurs when a blood vessel in the neck or brain becomes blocked.Blockage can be due to thrombosis, embolism and narrowing of artery (stenosis).Hemorrhagic stroke is because of bleeding into the brain through the rupture of a blood vessel. Hemorrhagic stroke can be in addition subdivided into intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH).

The concord symptom is abrupt numbness or weakness in the face, arms, or legs, especially on one side of the body. Sudden disorientation or difficulty speaking or understanding language. sudden loss of vision in one or both eyes; sudden difficulty walking, lightheadedness, or loss of balance or coordination; sudden severe headache of unknown cause.The most common risk factor for stroke is hypertension.Upper motor neuron lesion due to stroke outcomes in a constellation of sensorimotor impairments which includes muscle weakness, impaired selective motor control, spasticity, and proprioceptive deficits that intervene with normal gait.Gait is one of the most important aspects of a stroke rehabilitation program. Patients with stroke are characterized by decreased ankle dorsiflexion during the swing, which leads to a decrease in gait ability.

Hemiparetic gait is characterised by using particular spatiotemporal styles, along with decreased cadence, prolonged swing period on the paretic aspect, prolonged stance duration on the nonparetic side, and step length asymmetry.Post-stroke hemiplegic gait is a combination of deviations and compensatory movement dictated by way of residual functions.Decreased functional mobility is a well-known residual disability after stroke and is associated with the ability to move (e.g., get in and out of a bed or chair), walk a certain distance, and turn. , is related.

while remaining independent.

Proprioceptive neuromuscular facilitation (PNF) is a stretching technique used to improve muscle flexibility and has been exhibited to have a positive effect on active and passive range of motion. Proprioceptive neuromuscular facilitation (PNF) is a very powerful healing exercise for the improvement of muscle thickness, dynamic stability and gait and broadly used in medical settings to improve the bodily functioning of stroke patients.Some of the techniques of Proprioceptive neuromuscular facilitation are contarct-relax, hold-relax, rhythmic initiation etc.PNF techniques are done in diagnol pattern involving flexion and extension, abduction and adduction, internal and external rotation. Kinesiotape is an elastic therapeutic tape used for the treatment of various disorders.Kinesiotapingis theorize to have numerous features (1) restoring muscle characteristic by assisting weakened muscles,(2) reducing c ongestion through improving the flow of blood and lymphatic fluid, (3) decreasing ache by way of stimulating neurological system, and (4) correcting misaligned joints by retrieving muscle spasm. Depending on the direction of application and tape tension increasing proprioception and increasing or inhibiting muscle recruitment can be obtained. The effect and positive result of Kinesio Tape greatly centers on increase in neuromuscular recruitment.RCT was conducted by S.Choi et.al in 2020 on immediate effects of ankle nonelastic taping on balance and gait ability in patients with chronic stroke. 30 patients with stroke more than the duration of 6 months, both genders were included in this study. Non-elastic ankle taping is applied first, start at the bottom of the first metatarsal head and wrap the tape diagonally toward the fifth metatarsal head. Primary Outcome measure tools for static and dynamic balance measured by balance system SD and changes in gait parameters measured by GATErite system. Their study demonstrate that non-elastic ankle taping has a beneficial effect on static and dynamic balance ability scores, gait velocity, step length, and stride length in patients with chronic stroke. Another RCT study was carried by Youngsook Bae et.al in 2022 on immediate effects of lower leg kinesiotaping on ankle dorsiflexion and gait parameters in chronic stroke with foot drop.The aim of the study was to estimate the immediate effects kinesiotaping of lower leg on ankle dorsiflexion . Overall, 18 stroke patients aged 30-80 years were enrolled in this study .There were three conditions no taping, ankle taping and PNF with ankle taping with the time interval of 10 minutes between each condition. GATErite system was used to measure spatial and temporal aspects of gait.. They concluded that ankle taping and PNF with ankle taping significantly improves the dorsiflexion as compared to no taping.

Conditions
Stroke
Being tested
: lower leg kinesiotaping, propriocepticve neuromuscular facilitation, propriocepticve neuromuscular facilitation with lower leg kinesiotaping
Keywords
Stroke, ankle dorsiflexion, PNF
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • : lower leg kinesiotapingOther

    Kinesiotaping will be applied on tibialis anterior for 30 minutes for one session

  • propriocepticve neuromuscular facilitationOther

    :Proprioceptive neuromuscular facilitation hold relax technique will be applied to ankle with 15-30 repititions on affected side for one session

  • propriocepticve neuromuscular facilitation with lower leg kinesiotapingOther

    Kinesiotaping will be applied on tibialis anterior for 30 minutes with proprioceptive neuromuscular facilitation hold relax technique will be applied to ankle with 15-30 repititions on affected side for one session

Study groups in NCT05857657
Study groupRoleWhat they receive
lower leg kinesiotapingExperimentalKinesiotaping will be applied on tibialis anterior for 30 minutes for one session
Receives: Other: : lower leg kinesiotaping
propriocepticve neuromuscular facilitationExperimental:Proprioceptive neuromuscular facilitation hold relax technique will be applied to ankle with 15-30 repititions on affected side for one session
Receives: Other: propriocepticve neuromuscular facilitation
propriocepticve neuromuscular facilitation with lower leg kinesiotapingActive comparatorKinesiotaping will be applied on tibialis anterior for 30 minutes with proprioceptive neuromuscular facilitation hold relax technique will be applied to ankle with 15-30 repititions on affected side for one session
Receives: Other: propriocepticve neuromuscular facilitation with lower leg kinesiotaping

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time up and go test

    To determine fall risk and measure the progress of balance, sit to stand and walking. Subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again.The test is a reliable and valid test for quantifying functional mobility. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention.

    Measured: Baseline and after 1 hour

  2. Barthel Index

    The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently.Total score of 100 with proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.

    Measured: Baseline and after 1 hour

  3. Motor Assessment scale

    The Motor Assessment Scale (MAS) is a performance-based scale used to assess level of impairment and everyday motor function in patients with stroke. The 9 items assessment evaluates 5 Mobility and 3 Upper Limb activities, and 1 the severity of involuntary movements UMN lesions (clonus). Each of the items is scored on a 7 point hierarchical difficulty scale. A score of 0 indicates the individual is unable to complete any of the tasks within a category. A score of 6 implies the individual is not only able to perform the most difficult task, but also all lower scored tasks

    Measured: Baseline and after 1 hour

  4. Dynamic gait index

    The DGI assesses individual's ability to modify balance while walking in the presence of external demands. • The Dynamic Gait Index (DGI) was developed as a clinical tool to assess gait, balance and fall risk. It evaluates not only the. usual steady-state walking, but also walking during more challenging tasks. 8 functional walking tests are performed by the subject and marked out of three according to the lowest category which applies. 24 is the total individual score possible. Scores of 19 or less have been related to increase incidence of falls.

    [Time Frame: Both pre intervention and post intervention of only one treatment session.]

    Measured: Baseline and after 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2023
  2. Study start5 Mar 2023
  3. Primary completion15 Nov 2023
  4. Study completion15 Dec 2023

Resources

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
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05857657
Sponsor's protocol ID
REC/23/0202 Fatima Noor
Status last verified
Dec 2023
First submitted
31 Mar 2023
Last updated
27 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wall HK, Beagan BM, O'Neill J, Foell KM, Boddie-Willis CL. Addressing stroke signs and symptoms through public education: the Stroke Heroes Act FAST campaign. Prev Chronic Dis. 2008 Apr;5(2):A49. Epub 2008 Mar 15.

    PubMed 18341784

Questions about this trial

What is this clinical trial studying?

A study testing : lower leg kinesiotaping, propriocepticve neuromuscular facilitation and propriocepticve neuromuscular facilitation with lower leg kinesiotaping 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 27 Dec 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time up and go test (time frame: Baseline and after 1 hour). 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 NCT05857657, which also lists 1 linked publication.

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 27 Dec 2023.

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