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Clinical Trials/NCT05609136
NCT05609136
Completed
Not Applicable

Effect of Scapular Stabilization Exercises on Upper Extremity Spasticity and Motor Function in Patients With Chronic Stroke: A Double-Blind Randomized Controlled Study

Suleyman Demirel University1 site in 1 country36 target enrollmentOctober 15, 2022
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Suleyman Demirel University
Enrollment
36
Locations
1
Primary Endpoint
Modified Barthel Index
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

There is still no approved exact treatment for stroke, one of the leading causes of disability. Neurorehabilitation is an important treatment option for stroke patients with anatomical and functional impairments in their interhemispheric connections. However, special techniques with high effectiveness are being investigated to increase the success of general rehabilitation. In this context, scapula-focused stabilization techniques have been used in stroke patients recently. In this randomized controlled study, investigators aimed to examine the effect of scapular stabilization exercises on upper extremity spasticity and motor function in addition to neurorehabilitation in patients with chronic stroke. 22 chronic stroke patients will be included in the study. The patients will be divided into two groups as scapular exercise group and control group using the simple randomization method. Scapular stabilization exercises will be applied in combination with neurorehabilitation to the first group, while only neurorehabilitation will be applied to the control group. A 6-week (30 sessions) neurorehabilitation program will be applied to all groups, specially planned for the patient. Spasticity of the patients participating in the study Modified Ashworth Scale, upper extremity recovery levels Brunnstrom Recovery Stage, upper extremity functions Fugl Meyer Upper Extremity Scale and Wolf Motor Function Test, independence levels Functional Independence Scale , activities of daily living will be evaluated with the Modified Barthel Index and quality of life will be evaluated with the Stroke Specific Quality of Life Scale. The first evaluation of the patients will be made before the treatment, and each patient will be evaluated after the 6-week exercise program. After all data are collected, in-group and intergroup comparisons will be made.

Registry
clinicaltrials.gov
Start Date
October 15, 2022
End Date
August 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Huseyin Atceken

MSc Student, Physiotherapist

Suleyman Demirel University

Eligibility Criteria

Inclusion Criteria

  • 3 months past the stroke history
  • No previous history of stroke
  • Mini mental test score ≥ 24
  • Upper extremity (elbow, wrist and finger) spasticity level to be 1-3 according to Modified Ashworth Scale (MAS)
  • Upper extremity Brunnstrom recovery stage 2-5
  • No botulinum toxin injection for the affected upper extremity in the last 6 months
  • If he is using antispastic medication, his dose has not been changed in the last 1 month.
  • Consent to participate in the study

Exclusion Criteria

  • Having any neurological, psychiatric, orthopedic, unstable cardiovascular disease other than stroke
  • being pregnant
  • Having upper extremity contractures

Outcomes

Primary Outcomes

Modified Barthel Index

Time Frame: six weeks

Modified Barthel Index, which is used to measure the independence of patients in activities of daily living, was created by modifying the Barthel Index. It includes 10 items related to activities of daily living (nutrition, personal care, bathing, dressing, bowel and bladder care, toilet use, ambulation, transfers and stair climbing). There are levels between 0 and 5 for each item in Modified Barthel Index. Leveling points are different for each activity. At level 1, the patient is insufficient to perform the activity, while at level 5, the patient can do the activity without assistance, even if slowly. The total score is between 0-100 points. The higher the score, the lower the dependence of the patients on activities of daily living. Modified Barthel Index has good reliability and validity

Stroke Specific Quality of Life Scale

Time Frame: six weeks

It is a 49-item scale for 12 subcategories (mobility, vitality, upper extremity functionality, work/productivity, mood, self-care, social roles, family roles, language, vision, thinking, and personality) assessing the independence of stroke patients. It is rated using a 5-point Likert-type scale (1=Totally agree, 2=Somewhat partially agree, 3=Neither agree nor disagree, 4=Partly disagree, 5=Disagree). The higher the score, the better the quality of life of stroke patients.

The Fugl-Meyer Upper Extremity Scale

Time Frame: six weeks

It is a commonly used scale to determine the severity of stroke and measure recovery. Upper extremity sensorimotor impairment after stroke is usually evaluated using The Fugl-Meyer Upper Extremity Scale. It is considered the gold standard. The Fugl-Meyer Upper Extremity Scale is clinically applicable and has excellent reliability, validity and responsiveness. The scale consists of 33 items divided into 4 subscales: shoulder/elbow (18 items), wrist (5 items), hand (7 items) and coordination/speed (3 items). For each item, it is scored as 2 (performs the movement fully), 1 (does the movement partially), and 0 (the movement cannot be performed). A total of 66 points, with higher scores indicating better sensorimotor function.

Modified Ashworth Scale

Time Frame: six weeks

It is the most universally accepted clinical tool used to measure the increase in muscle tone. The Ashworth Scale was published in 1964 to assess spasticity in patients with multiple sclerosis. The original Ashworth scale is a 5-point numerical scale that grades spasticity from 0 to 5 (0 without resistance and 5 with one limb rigid in flexion or extension). In 1987, 1+ was added and modified to increase the sensitivity of the Ashworth Scale. Since the scale was modified, Modified Ashworth Scale has been applied as a measure of spasticity in clinical practice and research. The purpose of the Modified Ashworth Scale is to rate muscle tone between 0 (normal muscle tone) and 4 (rigid muscle) points.

Brunnstrom Recovery Stage

Time Frame: six weeks

It is a classification method developed to evaluate the upper extremities of patients. Staging used in prognosis follow-up also aims to create a common language among clinicians. For the upper extremity, stage 1 (flash stage), stage 2 (reflexes and spasticity start stage), stage 3 (stage where limb synergies are seen), stage 4 (stage where limb synergies begin to break down), stage 5 (stage where limb synergies are broken except for certain activities) It is a scale that grades impairment between stage 6 (normal motor movement) and stage 6 (normal motor movement).

Wolf Motor Function Test

Time Frame: six weeks

The test consists of 17 items. While 15 items evaluate skill and performance time for different functional activities, 2 items evaluate muscle strength. In performance time measurement, a maximum of 120 seconds is given for each of the 15 tasks and the individual is asked to complete the task as soon as possible during this time. All functional movements evaluated 0 = no interference, 1 = interference, 2 = plegia side involved but unable to complete task, 3 = performs task but in synergy pattern or moves very slowly, 4 = performs task near normal but slightly slower than normal; the target may have fine coordination or fluency problems, scored as 5 = doing the task and having normal movement. The average value of the total score is calculated for the functional skill score.

Functional Independence Measure

Time Frame: six weeks

It is a reliable assessment of the burden of care acquired due to the assistance patients need in performing a range of activities of daily living. Functional Independence Measure consists of 13-item motor domain (Functional Independence Measure-motor) and 5-item cognitive domain (Functional Independence Measure-cognitive) subcategory. All activities are rated on a seven-point ranking scale ranging from 1 (needs full assistance during activities) to 7 (does the activity completely independently). The Functional Independence Measure motor score ranges from 13 to 91 points, the cognitive score ranges from 5 to 35 points, and the total Functional Independence Measure score ranges from 18 to 126 points. Low scores indicate more addiction.

Study Sites (1)

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