NCT05607264

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

November 1, 2022

Last Update Submit

November 1, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Kinsiotaping

EXPERIMENTAL

patients who received kinesiotaping plus conventional treatment for chronic shoulder impingement syndrome.

Other: KinsiotapingOther: Conventional treatment

Virtual Reality training

EXPERIMENTAL

patients who received VR training plus conventional treatment for chronic shoulder impingement syndrome.

Other: Motion-controlled VR gamesOther: Conventional treatment

conventional treatment

ACTIVE COMPARATOR

patients who received conventional treatment for chronic shoulder impingement syndrome only.

Other: Conventional treatment

Interventions

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.

Kinsiotaping

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.

Virtual Reality training

patients received conventional treatment for chronic shoulder impingement syndrome only.

KinsiotapingVirtual Reality trainingconventional treatment

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. 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.
  • \. Patient complaint from pain and tendinitis in subacromial area more than 3 in VAS.
  • \. All patients complaint from difficulties in joining ADL activities. 7. All patients will assign written consent form.

You may not qualify if:

  • Subjects with the following criteria will be excluded from the study:
  • Shoulder fracture or instability.
  • Previous shoulder surgery.
  • Arthritis of the glenohumeral or acromioclavicular joints.
  • Cervical radiculopathy
  • Patients with visual disorders.
  • Diabetic patients.
  • Balance and coordination disorders.
  • Tumor and breast cancer.
  • Major trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic, Faculty of Physical Therapy, Cairo University, Egypt.

Dokki, 35111, Egypt

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Hend Ahmed, Physiotherapist

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 7, 2022

Study Start

March 1, 2021

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

November 7, 2022

Record last verified: 2022-11

Locations