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Clinical Trials/NCT07300605
NCT07300605
Completed
Not Applicable

The Effects of Kinesio Taping on the Upper Extremity Motor Function, Pain, General Health and Depression in Acute Stroke Patients: A Randomized Controlled Trial

Koç University1 site in 1 country26 target enrollmentStarted: June 1, 2018Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Koç University
Enrollment
26
Locations
1
Primary Endpoint
Change in Fugl-Meyer Wrist, Sitting Position Upper Extremity and Hand Scores

Overview

Brief Summary

This randomized, controlled clinical trial was conducted to evaluate the effects of kinesio taping on upper extremity motor recovery in patients with acute ischemic stroke who presented with flaccid muscle tone. Twenty-six adults were randomly assigned to either a kinesio taping group or a sham taping group, in addition to receiving standard rehabilitation. Participants were evaluated at baseline, at the end of the 3-week taping period, and at 6 weeks using validated measures of motor function, pain, general health, and depression. The study aimed to determine whether kinesio taping provides additional benefits beyond conventional rehabilitation in improving motor performance of the wrist and hand, reducing pain, and supporting overall functional and emotional well-being in the early phase of stroke recovery.

Detailed Description

This prospective, randomized, controlled parallel-group trial investigated the clinical effects of kinesio taping on motor recovery of the upper extremity in patients with acute ischemic stroke. Participants were adults aged 50-80 years, within the first six months after stroke, presenting with Brunnstrom Stage 1 flaccid upper extremity and hand. Individuals with hemorrhagic stroke, prior upper limb surgery, severe shoulder pain, additional neurological conditions, or musculoskeletal complications affecting the upper limb were excluded. All participants received standard rehabilitation, including positioning training, conventional exercises, and splinting as needed.

Participants were randomized (1:1) into a kinesio taping group or a sham taping group. The kinesio taping protocol followed standard facilitation techniques applied to the dorsum of the hand and forearm with appropriate tension, aiming to support finger, wrist, and hand activation. Sham taping was performed without tension and without crossing joints, to avoid therapeutic effect while maintaining participant blinding. Both groups received three taping applications over approximately three weeks.

Outcome measures included Brunnstrom staging, Fugl-Meyer Assessment (upper extremity, wrist, and hand subscales), Visual Analog Scale for hand pain, Health Assessment Questionnaire, and Beck Depression Inventory. Evaluations were performed before treatment, at the end of the 3-week intervention period, and at 6 weeks. Statistical analyses were conducted using standard non-parametric methods for intra- and inter-group comparisons.

The study was designed to determine whether kinesio taping provides additional benefit beyond conventional rehabilitation in facilitating neurophysiological recovery, improving wrist and hand motor function, reducing pain, supporting functional independence, and decreasing depressive symptoms in the acute phase of stroke. No adverse events were observed during the study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Participants and outcome assessors were blinded to group allocation

Eligibility Criteria

Ages
50 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults aged 50-80 years
  • Diagnosis of acute ischemic stroke confirmed by CT or MRI
  • Within first 6 months after stroke onset
  • Brunnstrom Stage 1 for upper extremity and hand (flaccid muscle tone)
  • Sufficient cognitive ability to follow instructions
  • Participation in inpatient or outpatient stroke rehabilitation
  • Ability to provide informed consent

Exclusion Criteria

  • Hemorrhagic stroke etiology
  • Prior upper extremity surgery, fracture, contracture, or heterotopic ossification
  • Brachial plexus injury or peripheral nerve lesions
  • Additional neurological disorders (e.g., Parkinson's disease, spinal cord injury, polyneuropathy)
  • Severe shoulder pain (VAS ≥ 5) that could interfere with assessments
  • Significant musculoskeletal disorders affecting the hemiplegic upper extremity
  • Uncontrolled comorbidities that prevent participation in rehabilitation
  • Inability to complete follow-up assessments

Outcomes

Primary Outcomes

Change in Fugl-Meyer Wrist, Sitting Position Upper Extremity and Hand Scores

Time Frame: Baseline, Week 3, Week 6

Fugl Meyer Rating Scale (FMRS) was used to evaluate motor function. This scale was developed to evaluate the patient's sensorimotor recovery after stroke by the Brunnstrom motor healing stages. The scale covers the upper extremity in 3 parts: the shoulder-elbow-forearm, the sitting position in the wrist, the hand; and allows the evaluation of reflex activity, synergy patterns and voluntary movements. It is a reliable method for assessing the severity of post-stroke sensorimotor impairment. The maximum total score for the upper extremity in FMRS is 66.

Secondary Outcomes

  • Change in Brunnstrom Staging (Upper Extremity and Hand)(Baseline, Week 3, Week 6)
  • Change in Visual Analog Scale (VAS) for Hand Pain(Baseline, Week 3, Week 6)
  • Change in Health Assessment Questionnaire (HAQ) Disability Index(Baseline, Week 3, Week 6)
  • Change in Beck Depression Inventory (BDI) Score(Baseline, Week 3, Week 6)

Investigators

Sponsor
Koç University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Havvanur Albayrak

Specialist Physician, Department of Physical Medicine and Rehabilitation

SB Istanbul Education and Research Hospital

Study Sites (1)

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