NCT05577013

Brief Summary

Stroke is described as rapidly developing clinical findings of localized or generalized impairment to cerebral function, with symptoms lasting 24 hours or longer, or leading to death, with no evident cause other than a vascular origin. Stroke is a prevalent and debilitating illness that affects people all around the world. Stroke is the second or third largest cause of mortality in adults, as well as one of the primary causes of adult disability. Because the majority of stroke patients survive the initial illness, the long-term impacts on patients and their families have the greatest influence on health. Kinesiotaping is a revolutionary rehabilitation procedure. It's most typically used to treat sports injuries, however, it is progressively becoming effective in overcoming other abnormalities. Kinesio Tex tape brand is a flexible, thin, porous cotton fabric with an adhesive backing manufactured by Dr. Kenzo Kase. It provides cutaneous stimulation which facilitates or limit movement, aids in the reduction of edema, reduces pain and correct joint positions for easing muscle spasms.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

October 10, 2022

Last Update Submit

December 9, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Fugel Meyer assessment scale for upper limb

    An assessment scale for post stroke hemiplegic patients and is performance-based impairment index. This scale is having 5 domains namely Motor functioning, Sensory Functioning, Balance, Joint Range of Motion and Joint pain. I divided the motor functioning for upper extremity into 0 to 66 points and evaluates mobility, speed and coordination

    week 8

  • Functionality of Upper Limb

    Upper Limb functionality is assessed by an instrument that consists of 20 items divided into 13 items that evaluate the movement patterns of the upper limb with a score from 0 (paralysis) to 5 (performs the typical movement pattern compared to the unaffected side)

    week 8

  • Box and Block Test (BBT)

    his test is used to evaluate the manual dexterity of post stroke patients. BBT is composed of wooden box with two equal compartments having 150 boxes in one compartment and patient is asked to move the boxes from one compartment to another within 60 seconds. Before starting the test an extra 15 seconds time is given to the patient for familiarization with the test. First the patient performed the activity with the healthy arm and then with the affected arm. Scoring is done on the basis of the number of boxes transferred from one compartment to another within 60 seconds

    week 8

Study Arms (2)

(Kinesiotaping and motor relearning program group

EXPERIMENTAL

The experimental group will receive kinesiotaping; Instructions before applying kinesiotape * Patients' skin must be clean, free of dirt, oil or sweat. * Long hair must be removed for proper adhesion to the skin. * Leave the tape upstretched 2-3 cm at start and end point of tape over the skin

Other: kinesiotaping

motor relearning program group

ACTIVE COMPARATOR

The control group will receive motor relearning programme exercises for 40 minutes. 1. Hitting a target on table from flexed elbow to extension of elbow 2. Hitting a target on front of table with shoulder flexion (reaching fwd) 3. Hitting a target on table with wrist extension 4. Pronation to supination while holding a bottle of water. 5. Rolling ball on table in forward, backward and sideways 6. Holding polystyrene cup and placing it on other side 7. Picking up blocks and placing them to other side 8. Holding polystyrene cup and placing them above and below level of sitting to front and sideways 9. Holding polystyrene cup and placing them above and below level of standing to front and sideways 10. pick small objects from one container to another

Other: motor relearning program

Interventions

It will be applied by kinesiotape certified physiotherapist on tendons in the direction of extensor muscle to facilitate range of motion by stretching 50%. At first it will be applied on extensor pollicis longus and extensor pollicis brevis muscles of hand, extensor digitorum and extensor indicis of last 4 fingers of hand. Triceps brachii in arm and Supraspinatus and Infraspinatus muscles to stabilize the gelnohumeral joint

(Kinesiotaping and motor relearning program group

Stacking up blocks Stacking up polystyrene cups Folding piece of cloth Using cutlery Pouring water into glass Closing/opening lid of bottles turning the pages of books or newspaper writing on paper Squeezing of ball Coloring in different shapes

motor relearning program group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male and female of age 18 -60 years
  • patients with post stroke duration of \>6 months
  • both ischemic and hemorrhagic stroke
  • modified ashworth scale of spasticity \< 3
  • muscle power by manual muscle testing (MMT) ≥ 2
  • no cognitive impairments by mini mental state examination (MMSE) \> 24
  • cortical skin sensitivity preserved (two point discrimination, barognosis, fine and crude touch)

You may not qualify if:

  • Participants failing to fall in this category would be excluded from the study.
  • being hospitalized due to any reason other than stroke
  • being subjected to treatment with botulinum toxin for \<1 year
  • any other condition which affects the upper extremity
  • contraindications for the application of Kinesio Taping: open wounds, skin infections such as cellulitis, allergies, skin xerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehman Medical Institute

Peshawar, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ayesha Afridi, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabia shafique, MS NMPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 13, 2022

Study Start

October 1, 2022

Primary Completion

February 20, 2023

Study Completion

February 20, 2023

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations