- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06674057
Additional Effects of Kinesio-Taping Along with Conservative Physical Therapy on Upper Limb Function, Range of Motion and Spasticity in the Patients with Subacute Stroke
A randomized control trial will be done on diagnosed stroke patients of subacute stage in Fauji Foundation Hospital Rawalpindi and leading edge physical therapy and rehabilitation clinic.The purpose of the study is to determine Additional Effects of Kinesio-Taping along with conservative Physical Therapy on upper limb function, Range of motion and Spasticity in the patients with Subacute Stroke. The conservational physical therapy includes Passive and active ROMs 25 repetitions each, 3 times per week. PNF stretching (hold relax) for spastic muscles for 20 repetitions with a 10 second hold and 10 second relaxation of the muscle group 3 times per week.
D1 flexion and extension for 20 repetitions 3 times per week. Kinesio tape 3 times per week. (Anchor opposed to effected compartment to provide facilitation and sustained stretch). with srtrngth training included in week 3-6 with a resistance band of medium resistance.
treatment time will be 30 minutes on alternate days for six weeks.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
The objectives of this study are:
- To determine the additional effects of kinesio taping in combination with physical therapy on ROM of upper limb shoulder, elbow and wrist joint in subacute stroke patients
- To determine the additional effects of kinesio taping in combination with physical therapy on upper limb spasticity in subacute stroke patients
- To determine the effects of kinesio taping on upper limb function in subacute stroke patients.
HYPOTHESIS:
Alternate Hypothesis:
There is a statistically significant difference between kinesio taping combined with physical therapy on ROM, spacticity and function of upper limb Shoulder, elbow and wrist joints in patients with subacute stroke compared to conventional physical therapy.
Null Hypothesis:
There is no statistically significant difference between kinesio taping combined with physical therapy on ROM, spacticity and function of upper limb Shoulder, elbow and wrist joints in patients with subacute stroke compared to conventional physical therapy.
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Rehabilitation department, Fauji Foundation Hospital , leading edge physical therapy and rehabilitation islamabad.
Study duration: 6 months.
Selection Criteria:
Inclusion Criteria
- Age group: 40-65 years onwards
- Both males and females
- Patients with history of diagnosed stroke and lie within subacute stage of stroke
- MAS scale score of 1_2
Exclusion Criteria
- Any congenital deformities
- cognitive deficits
- Fractures
- Upper limb surgery
Sampling technique: Convenience sampling
Outcome Measures:
Data will be collected on Demographics and general information Goniometer will be used to assess the range of motion of shoulder, elbow and wrist joint Modified Ashworth scale will be used to determine the level of spasticity in the participants.
Wolf motor function test scale for upper limb will be used to assess upper limb function.
Experimental Group (A) = This group will receive kinesio taping every alternate day for six weeks combined with conservational physical therapy which includes AROMs, PROMs, PNF D1 flexion and extension, resistance raining using resistance band of medium resistane.
and their outcomes will be measured at baseline and at 3rd week and at the end of 6th week treatment.
Control group (B) =this group will not receieve kinesio taping , only conservationall Physical therapy will be given and their outcomes will be observed at the baseline, at third week and then after treatment of 06 weeks.
Data analysis techniques:
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study.
A printed questionnaire will be provided to the participents after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.
Significance of the study:
This study will add data to the literature. Providing evidence-based data and aiding healthcare providers to incorporate kinesio taping as an adjunct intervention.
This study will also provide a feasible and cost-effective treatment to the patient diagnosed with subacute stroke.
Kinesio taping is easy to apply, potentially beneficial treatment options for patients with subacute stroke upper limb dysfunction.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: SOHAIB AHMAD, DPT
- Phone Number: +923158054156
- Email: sohaib3636@gmail.com
Study Locations
-
-
-
Islamabad, Pakistan, 44000
- Recruiting
- Foundation University College of Physical Thrapy
-
Contact:
- Sana Bashir, MS-CPT, PhD*
- Phone Number: 003218529475
- Email: drsana.bashir@fui.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age group: 40-65 years onwards
- Both males and females
- Patients with history of diagnosed stroke and lie within subacute stage of stroke
- MAS scale score of 1_2
Exclusion Criteria:
- Any congenital deformities
- cognitive deficits
- Fractures
- Upper limb surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
It includes participants receiving kinesio taping in addition to conservational physical therapy for subacute stroke patient's upper limb ROM/spasticity/function. for a period of 6 weeks.
|
The experimental group will receive the following treatment for week 1-3 (3 days on alternate days):
For week 3-6 the treatment will include:
|
|
Active Comparator: control group
It includes participants receiving conservational physical therapy for subacute stroke patient's upper limb ROM/spasticity/function. for a period of 6 weeks.
|
The control group will receive the following treatment for week 1-3 on alternate days:
For week 3-6 the treatment will include:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spasticity
Time Frame: 6 weeks
|
velocity dependant passive resistance to stretch will be assesed using the modified ashworth scale.
|
6 weeks
|
|
Upper limb function
Time Frame: 6 weeks
|
Upper limb function will be assessed using the wolf motor function test for upper limb.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion
Time Frame: 6 weeks
|
range of motion of Wrist, Elbow and shoulder joint will be assessed using a goiniometer.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2024/42
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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