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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05607264
Other study ID # Hend_PhD_2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date June 1, 2022

Study information

Verified date November 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Purpose of the Study: to compare between the effect of kinesio taping technique versus virtual reality technique in rehabilitation of patients with chronic shoulder impingement syndrome.


Description:

Rotator cuff disorders are considered to be among the most common causes of shoulder pain and disability encountered in both primary and secondary care, with subacromial impingement syndrome in particular being the most common disorder, resulting in functional loss and disability, of the shoulder. There is a lack of literature about virtual reality exergaming in subjects with orthopedic problems. To reduce UL impairment, new therapeutic approaches, such as constraint-induced movement therapy, robotic arm training, and virtual reality therapy (VRT), have been successfully employed over the last decade. Kinesio taping is the increasingly popular method for preventing and treating sports injuries. The tape helps to maintain the joint position, increases the proprioceptive awareness, and assists in removal of exudates thereby reducing pain and improves the muscle function. So as there is lag in literature regarding the best type of treatment for patients with chronic impingement syndrome so this study will be conducted to compare between kinesiotaping and virtual reality and to determine the best treatment for patients with chronic Shoulder Impingement Syndrome (SIS).


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date June 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria: - 1. Patients will be diagnosed with chronic shoulder impingement syndrome (who had supraspinatus tendinitis stage (II) 2. Ages 25-40 years 3. Both sexes will be included. 4. Patients complaint from limitation in the ROM in abduction flexion and external rotation. 5. Patient complaint from pain and tendinitis in subacromial area more than 3 in VAS. 6. All patients complaint from difficulties in joining ADL activities. 7. All patients will assign written consent form. Exclusion Criteria: Subjects with the following criteria will be excluded from the study: 1. Shoulder fracture or instability. 2. Previous shoulder surgery. 3. Arthritis of the glenohumeral or acromioclavicular joints. 4. Cervical radiculopathy 5. Patients with visual disorders. 6. Diabetic patients. 7. Balance and coordination disorders. 8. Tumor and breast cancer. 9. Major trauma.

Study Design


Intervention

Other:
Kinsiotaping
Patients received the kinesiotaping over supraspinatus muscle and deltoid muscle, tape will be removed every three days and subjects will return back to the clinic to reapplication of tape again. Patients received the same therapeutic treatment 3 times/ week for four weeks. KT is air permeable and water resistant, allowing it to stay in place for three to five days.
Motion-controlled VR games
Virtual Rehab utilizes the unique characteristics of Microsoft Kinects motion technology to track and capture the movements of the patients so that patients become immersed in a 3D environment where they interact with the game. Subjects will include in a supervised virtual reality exergaming program for shoulder movements for 4 weeks, 3 days per week and 10 minutes for session.
Conventional treatment
patients received conventional treatment for chronic shoulder impingement syndrome only.

Locations

Country Name City State
Egypt Outpatient clinic, Faculty of Physical Therapy, Cairo University, Egypt. Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessing the change in musculoskeletal disorders of the upper limbs Assessment by using Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). The DASH is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs. Scoring the DASH 30-item disability/symptom section:
1) Item responses range from 1 (e.g. no difficulty, not at all, not limited, none, strongly disagree) to 5 (e.g. unable, extremely, unable, strongly agree). Scoring the optional 2 4-item high performance sections: 1) Add values of each response, then divide by 4, subtract 1 and multiply by 25: [((sum of values/4) - 1)*25]. 2) Optional modules should not be scored if items are missing. Arabic version of DASH questionnaire will be used, Which is reliable and valid to be used for evaluating upper extremity work related injuries.
at baseline and after 4 weeks of intervention
Primary Assessing the change in pain intensity Assessment by using visual analouge scale (VAS). It was used to assess the intensity of pain. Operationally a VAS is usually a horizontal line, l00 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. at baseline and after 4 weeks of intervention
Primary Assessing the change in shoulder range of motion Assessment by using Electro goniometer. It was used to measure shoulder ROM (flexion, abduction, internal rotation). at baseline and after 4 weeks of intervention
Primary Assessing the change in muscle activity of Supraspinatus muscle Assessment by using Electromyogram (EMG). It was used to measure muscle activity of Supraspinatus, infraspinatus, anterior and middle deltoid. at baseline and after 4 weeks of intervention
See also
  Status Clinical Trial Phase
Recruiting NCT03468088 - Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome N/A
Completed NCT04599127 - The Effect of Mobilization With Movement in Individuals With Shoulder Impingement Syndrome N/A
Completed NCT03573765 - Epidemiology and Outcomes of Upper Limb Surgery: Analysis of Routine Data