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Effects of Virtual Reality in Adhesive Capsulitis on Pain, Range of Motion and Function

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional Physical therapy
Virtual reality group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adhesive Capsulitis focused on measuring Virtual Reality ,Adhesive Capsulitis , Range of Motion

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ranges between 25 to 60
  2. Both gender were included
  3. Primary idiopathic type
  4. No eyesight problems
  5. Normal cognition and could follow instructions when using the system (score of 20 or more in mini mental state examination)
  6. Clinically confirmed to ensure frozen shoulders through perform different physical tests i.e. speed tests, empty can test etc

Exclusion Criteria:

  1. History of diabetes mellitus
  2. Any history of previous upper limb fracture
  3. Received steroids injection in the shoulder
  4. Any history of systematic or malignant disease

Sites / Locations

  • Services Hospital, Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional physical therapy

Virtual reality group

Arm Description

Subjects in group A was treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise.

group B was treated with virtual reality stimulation given for 30 minutes per session through kinetic Xbox with sensory accelerator model no.1414.Two traditional training activities was used to improve shoulder Range of motion i.e. badminton and American baseball activity 12 times of the training Baseline treatment protocol hot pack and ultrasound was applied to both groups. Treatment duration for both groups was 30 minutes. Each subjects were receive a total 4 week protocol with 03 treatment sessions per week.

Outcomes

Primary Outcome Measures

Visual Analogue Scale
Changes from the Baseline Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain.
ROM Shoulder flexion (right)
Changes from the Baseline ROM range of Motion of Shoulder flexion was taken with the Help of Goniometer
ROM Shoulder flexion (left)
Changes from the Baseline ROM range of Motion of Shoulder flexion was taken with the Help of Goniometer
ROM Shoulder External rotation(right)
Changes from the Baseline ROM range of Motion of Shoulder External rotation was taken with the Help of Goniometer
ROM Shoulder External rotation(left)
Changes from the Baseline ROM range of Motion of Shoulder External rotation was taken with the Help of Goniometer
ROM Shoulder Abduction(right)
Changes from the Baseline ROM range of Motion of Shoulder Abduction was taken with the Help of Goniometer
ROM Shoulder Abduction(left)
Changes from the Baseline ROM range of Motion of Shoulder Abduction was taken with the Help of Goniometer
Shoulder Pain and Disability Index
Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with ADLs requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. The pain scale is summed up to a total of 50 while the disability scale sums up to 80. The total SPADI score is expressed as a percentage. A score of 0 indicates best 100 indicates worst. A higher score shows more disability. In scoring SPADI, any question missed should be taken out of the total score of each subscale. i.e if 1 question is omitted in the pain section, the total score is divided by 40.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2022
Last Updated
May 31, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05398549
Brief Title
Effects of Virtual Reality in Adhesive Capsulitis on Pain, Range of Motion and Function
Official Title
Effects of Virtual Reality in Adhesive Capsulitis on Pain, Range of Motion and Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Adhesive capsulitis (AC) also known as frozen shoulder typically manifests to decrease range of motion (ROM) and function and increase pain in shoulder. Objective of this study is to find the effects of virtual reality (VR) in adhesive capsulitis on pain, range of motion and function to decrease pain and improve range of motion and function. The study design will be a quasi-experimental study that will be used to compare the effects of virtual reality with conventional physical therapy. Subjects with adhesive capsulitis meeting the predetermined inclusion & exclusion criteria will be divided into two groups using lottery method. Pre assessment will be done using visual analogue scale (VAS), shoulder pain and disability index (SPADI) tool and active shoulder flexion and abduction as subjective measurements. Subjects in group A will be treated with virtual reality stimulation given for 30 minutes per session through kinetic Xbox with sensory accelerator model no.1414. Two traditional training activities will be used to improve shoulder Range of motion i.e. shoulders finger ladder training activity and single curved shoulder training activity 12 times (3 rounds in each practice) of the training 1 . Patients will be required to complete standard training task by interacting with designed VR rehabilitative training games under the supervision of physical therapists and subjects in group B will be treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise. Baseline treatment protocol hot pack will be applied to both groups. Treatment duration for both groups will be 30 minutes. Each subject will receive a total 6 week protocol with 02 treatment sessions per week. Post treatment reading will be recorded after the end of 2 nd , 4th and 6th treatment weeks. Recorded values will be analyzed for any change using SPSS 21.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Virtual Reality ,Adhesive Capsulitis , Range of Motion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects in group A was treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
Subjects in group A was treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise.
Arm Title
Virtual reality group
Arm Type
Experimental
Arm Description
group B was treated with virtual reality stimulation given for 30 minutes per session through kinetic Xbox with sensory accelerator model no.1414.Two traditional training activities was used to improve shoulder Range of motion i.e. badminton and American baseball activity 12 times of the training Baseline treatment protocol hot pack and ultrasound was applied to both groups. Treatment duration for both groups was 30 minutes. Each subjects were receive a total 4 week protocol with 03 treatment sessions per week.
Intervention Type
Other
Intervention Name(s)
Conventional Physical therapy
Intervention Description
Subjects in group A was treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise
Intervention Type
Other
Intervention Name(s)
Virtual reality group
Intervention Description
group B was treated with virtual reality stimulation given for 30 minutes per session through kinetic Xbox with sensory accelerator model no.1414. Two traditional training activities was used to improve shoulder Range of motion i.e. badminton and American baseball activity 12 times of the training.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Changes from the Baseline Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain.
Time Frame
4 weeks
Title
ROM Shoulder flexion (right)
Description
Changes from the Baseline ROM range of Motion of Shoulder flexion was taken with the Help of Goniometer
Time Frame
4 weeks
Title
ROM Shoulder flexion (left)
Description
Changes from the Baseline ROM range of Motion of Shoulder flexion was taken with the Help of Goniometer
Time Frame
4 weeks
Title
ROM Shoulder External rotation(right)
Description
Changes from the Baseline ROM range of Motion of Shoulder External rotation was taken with the Help of Goniometer
Time Frame
4 weeks
Title
ROM Shoulder External rotation(left)
Description
Changes from the Baseline ROM range of Motion of Shoulder External rotation was taken with the Help of Goniometer
Time Frame
4 weeks
Title
ROM Shoulder Abduction(right)
Description
Changes from the Baseline ROM range of Motion of Shoulder Abduction was taken with the Help of Goniometer
Time Frame
4 weeks
Title
ROM Shoulder Abduction(left)
Description
Changes from the Baseline ROM range of Motion of Shoulder Abduction was taken with the Help of Goniometer
Time Frame
4 weeks
Title
Shoulder Pain and Disability Index
Description
Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with ADLs requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. The pain scale is summed up to a total of 50 while the disability scale sums up to 80. The total SPADI score is expressed as a percentage. A score of 0 indicates best 100 indicates worst. A higher score shows more disability. In scoring SPADI, any question missed should be taken out of the total score of each subscale. i.e if 1 question is omitted in the pain section, the total score is divided by 40.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ranges between 25 to 60 Both gender were included Primary idiopathic type No eyesight problems Normal cognition and could follow instructions when using the system (score of 20 or more in mini mental state examination) Clinically confirmed to ensure frozen shoulders through perform different physical tests i.e. speed tests, empty can test etc Exclusion Criteria: History of diabetes mellitus Any history of previous upper limb fracture Received steroids injection in the shoulder Any history of systematic or malignant disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tehreem Mukhtar, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Services Hospital, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Virtual Reality in Adhesive Capsulitis on Pain, Range of Motion and Function

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