Clinical trial NCT05398549: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: Virtual Reality ,Adhesive Capsulitis , Range of Motion
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects in group A was treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise
Primary purpose: OTHER

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 \&amp; 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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 4 weeks
measure: ROM Shoulder flexion (right)
timeFrame: 4 weeks
measure: ROM Shoulder flexion (left)
timeFrame: 4 weeks
measure: ROM Shoulder External rotation(right)
timeFrame: 4 weeks
measure: ROM Shoulder External rotation(left)
timeFrame: 4 weeks
measure: ROM Shoulder Abduction(right)
timeFrame: 4 weeks
measure: ROM Shoulder Abduction(left)
timeFrame: 4 weeks
measure: Shoulder Pain and Disability Index
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Hospital, Lahore
state: Punjab
Study officials:
affiliation: Riphah International University
name: Tehreem Mukhtar, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References: