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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
: lower leg kinesiotaping
propriocepticve neuromuscular facilitation
propriocepticve neuromuscular facilitation with lower leg kinesiotaping
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 Stroke, ankle dorsiflexion, PNF

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: -

Sites / Locations

  • Riphah Rehabilitation centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

lower leg kinesiotaping

propriocepticve neuromuscular facilitation

propriocepticve neuromuscular facilitation with lower leg kinesiotaping

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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
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.]

Secondary Outcome Measures

Full Information

First Posted
March 31, 2023
Last Updated
May 4, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05857657
Brief Title
Immediate Effects of PNF With Lower Leg Kinesio Taping in Chronic Stroke
Official Title
Immediate Effects of Proprioceptive Neuromuscular Facilitation With Lower Leg Kinesiotaping on Ankle Dorsiflexion, Gait and Functional Mobility in Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, ankle dorsiflexion, PNF

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lower leg kinesiotaping
Arm Type
Experimental
Arm Description
Kinesiotaping will be applied on tibialis anterior for 30 minutes for one session
Arm Title
propriocepticve neuromuscular facilitation
Arm Type
Experimental
Arm Description
:Proprioceptive neuromuscular facilitation hold relax technique will be applied to ankle with 15-30 repititions on affected side for one session
Arm Title
propriocepticve neuromuscular facilitation with lower leg kinesiotaping
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
: lower leg kinesiotaping
Intervention Description
Kinesiotaping will be applied on tibialis anterior for 30 minutes for one session
Intervention Type
Other
Intervention Name(s)
propriocepticve neuromuscular facilitation
Intervention Description
:Proprioceptive neuromuscular facilitation hold relax technique will be applied to ankle with 15-30 repititions on affected side for one session
Intervention Type
Other
Intervention Name(s)
propriocepticve neuromuscular facilitation with lower leg kinesiotaping
Intervention Description
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
Primary Outcome Measure Information:
Title
Time up and go test
Description
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.
Time Frame
Baseline and after 1 hour
Title
Barthel Index
Description
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.
Time Frame
Baseline and after 1 hour
Title
Motor Assessment scale
Description
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
Time Frame
Baseline and after 1 hour
Title
Dynamic gait index
Description
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.]
Time Frame
Baseline and after 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tehreem Mukhtar, MS
Phone
03134715275
Email
tehreem.mukhtar@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Tehreem Mukhtar, ms
Email
tehreem.mukhtar@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatima Noor
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tehreem Mukhtar, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18341784
Citation
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.
Results Reference
background

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

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