Clinical trial NCT06460662: Effects of Agility and Perturbation Based Training in Addition to Routine Physical Therapy
Official title: Effects of Agility and Perturbation Based Training in Addition to Routine Physical Therapy on Pain, Function and Quality of Life in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: pain
function
quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis is a degenerative joint disease. Knee OA patients sometimes report episodes of knee instability that limit their ADLs. The episodes of instability are similar to those reported in knee ligament injuries. It is believed that modifications of interventions that are used to promote knee stability in knee ligament injuries can be used in knee OA to enhance knee stability and function. The purpose of this study will be to determine the effects of agility and perturbation-based training in addition to routine physical therapy on pain, function, quality of life and disability in knee osteoarthritis.

Detailed description: A Randomized Clinical Trial will be conducted at Al Syed Touqeer Altaf Surgical Hospital through a convenience sampling technique on 26 patients, which will be allocated using computer-generated randomization into two groups. Group A will be treated with agility and perturbation training techniques in addition to the same routine physical therapy as Group B, and Group B will receive only routine physical therapy. Outcome measures will be conducted through NPRS, WOMAC, SF-36, and KOS-ADLs questionnaires. All the outcome measures will be assessed pre and post-treatment, and the assessor will be blind. Frequency of the treatment will be 3 sessions per week for 4 weeks. Data will be analyzed using SPSS software version 25.

Eligibility criteria: Inclusion Criteria:

* Both male and female.
* Subjects with Kellgren and Lawrence grade II and III osteoarthritis.
* OA diagnosed subjects according to American College of Rheumatology ACR criteria;

  * Morning stiffness ≤ 30 minutes.
  * Crepitus with active motion of the knee (while weight bearing).
  * Tenderness to palpation of the bony margins of the joint, bony enlargement, and no palpable warmth.

Exclusion Criteria:

* Ligament or meniscal injury around the knee.
* Suffering from acute synovitis
* Neuromuscular disorders.
* Cognitive impairments.
* Required use of an assistive device for ambulation.
* Reported a history of 2 or more falls within the previous year.
* Undergone total knee arthroplasty.
* Uncontrolled hypertension, history of cardiovascular disease, neurological disorders that affected lower extremity function.
* Severe visual problems.

Primary outcomes:
measure: Numeric pain rate scale (NPRS)
timeFrame: upto 4 weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: upto 4 weeks
measure: SF-36 (Short form)
timeFrame: upto 4 weeks
measure: Knee Outcome Survey Activities of Daily Living KOS-ADLS
timeFrame: upto 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sher Shah Road, Shadbagh
state: Punjab
Study officials:
affiliation: Riphah International University,Lahore
name: Maryam Ijaz, MSPT*
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27.
citation: Jamtvedt G, Dahm KT, Christie A, Moe RH, Haavardsholm E, Holm I, Hagen KB. Physical therapy interventions for patients with osteoarthritis of the knee: an overview of systematic reviews. Phys Ther. 2008 Jan;88(1):123-36. doi: 10.2522/ptj.20070043. Epub 2007 Nov 6.
citation: Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013.