NCT06511557

Brief Summary

It is necessary to explore the novel rehabilitation strategies to treat knee osteoarthritis. Although kinetic chain exercises have shown efficacy but there is growing interest in Virtual Reality training using Xbox Kinect because it has the potential to enhance motivation and patient's adherence to Rehabilitation. The aim of this study is to compare the effectiveness of both interventions and provide a valuable insight to optimize the therapeutic strategies for treating knee osteoarthritis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

July 15, 2024

Last Update Submit

July 15, 2024

Conditions

Keywords

Knee OsteoarthritisXbox kineticVirtual Reality RehabilitationKinetic chain exercises

Outcome Measures

Primary Outcomes (4)

  • Numeric Pain Rating Scale:

    The Numeric Pain Rating Scale (NPRS) is used to assess pain. On an 11-point Numeric scale, 0 represents no pain and 10 Represents the worst imaginable pain.

    [Time Frame: 8 weeks]

  • Knee injury and Osteoarthritis Outcome score (KOOS PS):

    It is a self- administered questionnaire, designed for the assessment of individuals with knee osteoarthritis and injury. It consists of five subscales such as Pain, Activities of daily living , Symptoms, Sport and recreational activities and Quality of life related to knee. The KOOS short form typically consists of 7 questions covering five domains: Pain: 1 question Other Symptoms: 1 question Function in Daily Living (ADL): 1 question Function in Sport and Recreation (Sport/Rec): 2 questions Knee-related Quality of Life (QOL): 2 questions Each question is scored on a Likert scale ranging from 0 to 4, with 0 indicating no symptoms and 4 indicating extreme symptoms. The total score for the KOOS short form can range from 0 to 28 but we use reverse percentage for scoring which is from 0 to 100 precent with higher scores indicating greater severity in knee function.

    [Time Frame: 8 weeks]

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC):

    It is a self-administered questionnaire widely used for the assessment of Health status of individuals With Osteoarthritis of Hip or Knee. It has three subscales such as Pain, Stiffness and Physical Function. The WOMAC questionnaire consists of 24 questions divided into three subscales: Pain (5 questions) Stiffness (2 questions) Physical Function (17 questions) Each question is answered on a Likert scale ranging from 0 to 4, with 0 indicating no symptoms and 4 indicating extreme symptoms. Therefore, the total score for the WOMAC index can range from 0 to 96, with higher scores indicating greater severity of osteoarthritis symptoms.

    [Time Frame: 8 weeks]

  • Range of Motion (Goniometer):

    It is employed as a benchmark technique for the assessment of Range of motion of a joint, measured using a goniometer. Goniometer measures the joint ranges in every plane of the joint , it's measurements are highly reliable.

    [Time Frame: 8 weeks]

Study Arms (2)

Non immersive virtual reality (Xbox kinetic)

EXPERIMENTAL

* Track and field. * Skiing. * Dance Central. * Kinect sports.

Device: Non immersive virtual reality ( xbox kinetic)

Kinetic Chain Exercises

ACTIVE COMPARATOR

Closed chain: Terminal Knee Extension. * Semi squat. * Forward step up and down. Open chain: * SLR in lying. * Knee extension in sitting.

Other: Kinetic chain exercises

Interventions

Treatment starts with a gentle warm-up i.e. hot pack for 10 minutes and gentle stretching of Quadriceps, hamstrings and calves. Each game was performed for 10 minutes with 1 minute rest between games. 3 sessions Per Weeks for 8 weeks (45 Min per Session) were given. All the exergames target muscles like Hamstring, Quadriceps and calves to improve function of knee joint and reduce pain. Baseline assessment was done at the start of the session and proper cool down and stretching will be performed at the end of each session to promote flexibility and reduce muscle soreness

Non immersive virtual reality (Xbox kinetic)

Session starts with a gentle warm-up i.e. Hot pack for 10 minutes and gentle stretching. Each exercise is performed in 2 sets, each set of 10 repetitions with 1min rest between sets. 3 sessions Per Weeks for 8 weeks (45 Min Per Session) were given .Kinetic chain exercises involve integrated movements that engage multiple joints and muscle groups \& focus on strengthening muscles like quadriceps, hamstrings, glutes, and calf muscles, improving joint stability, function, and reducing pain. Baseline assessment was done at the start of the session and proper cool down and stretching was performed at the end of each session to promote flexibility and reduce muscle soreness

Kinetic Chain Exercises

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male \& female
  • Age 50 or older.
  • Body mass index (BMI) between 18.9kg/m2 and 29.9 kg/m2.
  • Diagnosed with Grade II knee OA
  • Have knee pain \> 4 on NPRS
  • Ability to engage in moderate physical activity.

You may not qualify if:

  • Severe comorbidities limiting physical activity.
  • History of Hip and Knee arthroplasty.
  • Cognitive impairments affecting comprehension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IIMCT Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Related Publications (9)

  • Lim WB, Al-Dadah O. Conservative treatment of knee osteoarthritis: A review of the literature. World J Orthop. 2022 Mar 18;13(3):212-229. doi: 10.5312/wjo.v13.i3.212. eCollection 2022 Mar 18.

    PMID: 35317254BACKGROUND
  • Hall M, van der Esch M, Hinman RS, Peat G, de Zwart A, Quicke JG, Runhaar J, Knoop J, van der Leeden M, de Rooij M, Meulenbelt I, Vliet Vlieland T, Lems WF, Holden MA, Foster NE, Bennell KL. How does hip osteoarthritis differ from knee osteoarthritis? Osteoarthritis Cartilage. 2022 Jan;30(1):32-41. doi: 10.1016/j.joca.2021.09.010. Epub 2021 Sep 29.

    PMID: 34600121BACKGROUND
  • Ozudogru A, Gelecek N. Effects of closed and open kinetic chain exercises on pain, muscle strength, function, and quality of life in patients with knee osteoarthritis. Rev Assoc Med Bras (1992). 2023 Jul 17;69(7):e20230164. doi: 10.1590/1806-9282.20230164. eCollection 2023.

    PMID: 37466598BACKGROUND
  • Ng WH, Jamaludin NI, Sahabuddin FNA, Ab Rahman S, Ahmed Shokri A, Shaharudin S. Comparison of the open kinetic chain and closed kinetic chain strengthening exercises on pain perception and lower limb biomechanics of patients with mild knee osteoarthritis: a randomized controlled trial protocol. Trials. 2022 Apr 15;23(1):315. doi: 10.1186/s13063-022-06153-8.

    PMID: 35428274BACKGROUND
  • Byra J, Czernicki K. The Effectiveness of Virtual Reality Rehabilitation in Patients with Knee and Hip Osteoarthritis. J Clin Med. 2020 Aug 14;9(8):2639. doi: 10.3390/jcm9082639.

    PMID: 32823832BACKGROUND
  • Raposo F, Ramos M, Lucia Cruz A. Effects of exercise on knee osteoarthritis: A systematic review. Musculoskeletal Care. 2021 Dec;19(4):399-435. doi: 10.1002/msc.1538. Epub 2021 Mar 5.

    PMID: 33666347BACKGROUND
  • van den Bosch MHJ. Osteoarthritis year in review 2020: biology. Osteoarthritis Cartilage. 2021 Feb;29(2):143-150. doi: 10.1016/j.joca.2020.10.006. Epub 2020 Nov 24.

    PMID: 33242602BACKGROUND
  • Dantas LO, Salvini TF, McAlindon TE. Knee osteoarthritis: key treatments and implications for physical therapy. Braz J Phys Ther. 2021 Mar-Apr;25(2):135-146. doi: 10.1016/j.bjpt.2020.08.004. Epub 2020 Sep 8.

    PMID: 33262080BACKGROUND
  • Nambi G, Abdelbasset WK, Elsayed SH, Khalil MA, Alrawaili SM, Alsubaie SF. Comparative effects of virtual reality training and sensory motor training on bone morphogenic proteins and inflammatory biomarkers in post-traumatic osteoarthritis. Sci Rep. 2020 Sep 28;10(1):15864. doi: 10.1038/s41598-020-72587-2.

    PMID: 32985509BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • syed shakil urrehman, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking refers to a practice where study participants are prevented from knowing certain information that may somehow influence them thereby tainting the results.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Clinical study in which two or more groups of participants receive different interventions. Participants are assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial. Assignment to a group usually is randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 22, 2024

Study Start

November 16, 2023

Primary Completion

August 1, 2024

Study Completion

September 30, 2024

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations