Effects of Agility and Perturbation Based Training in Addition to Routine Physical Therapy

NCT06460662 | Completed

• 1 other identifier: REC/RCR & AHS/23/0193 Maryam
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

pain; function; quality of life

Outcome Measures

Primary Outcomes (4)

• Numeric pain rate scale (NPRS)

  Numeric pain rate scale will be used to quantify patient level of pain. The Numeric Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The common format is a horizontal bar or line. Although various iterations exist, the most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from (no pain at all) to 10 (worst imaginable pain) i.e. higher scores indicating greater pain intensity. High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation. For construct validity, the NPRS was shown to be highly correlated with the VAS in patients with rheumatic and other chronic pain conditions (pain\>6 months): correlations range from 0.86 to 0.95.

  upto 4 weeks

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Patients' knee function and stiffness will be measured through the Western Ontario and McMaster Universities Arthritis Index (WOMAC) . It is a self-administered questionnaire consisting of 24 items divided into 3 subscales; Pain-5 items, Stiffness-2 items, Physical Function-17 items . WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities. WOMAC is available in over 65 languages and has been linguistically validated. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually, a sum of the scores for all three subscales gives a total WOMAC score.

  upto 4 weeks

• SF-36 (Short form)

  36-Item Short Form Survey (SF-36) will be used to assess the quality of life. (SF-36) is an outcome measure instrument that is often used, a well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study, which is an objective measure of quality of life. It comprises 36 questions that cover eight domains of health. The 36 questions on the SF-36 are meant to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role, and mental health.Possible scores range from 0 to 100, with higher scores representing better health status.

  upto 4 weeks

• Knee Outcome Survey Activities of Daily Living KOS-ADLS

  Knee outcome survey ADLS will be used to measure disability. The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, and then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. The ADLS demonstrated high test-retest reliability in 52 subjects with knee pathology. The ICC score for test-retest reliability over a 24 hour period was .97. Construct validity was determined through correlations with the Lysholm Knee Scale (r = .78 to .86).

  upto 4 weeks

Study Arms (2)

Agility and perturbation training group

EXPERIMENTAL

Group A will receive agility and perturbation training techniques in addition to the same routine physical therapy as Group B. The Agility training exercises include: * Side Stepping * Braiding Activities * Front and Back Crossover Steps During Forward Ambulation * Multiple Changes in Direction During Walking on Therapist Command The perturbation training exercises include: * Double-Leg Foam Balance Activity * Tilt board Balance Training * Rollerboard and Platform Perturbations

Other: Routine Physical Therapy

Routine physical therapy

ACTIVE COMPARATOR

Group B: Routine physical therapy Group that includes: * Calf Stretching * Hamstring Stretching * Prone Quadriceps Stretching * Long-Sitting Knee Flexion and Extension * Quadriceps setting * Supine Straight Leg Raises * Prone Hip Extensions * Standing Hamstring Curls With Cuff Weights * Standing Calf Raises * Treadmill Walking * Mobilization techniques

Other: Routine Physical Therapy

Interventions

Routine Physical Therapy OTHER

Group B: Routine physical therapy Group that includes: * Calf Stretching * Hamstring Stretching * Prone Quadriceps Stretching * Long-Sitting Knee Flexion and Extension * Quadriceps setting * Supine Straight Leg Raises * Prone Hip Extensions * Standing Hamstring Curls With Cuff Weights * Standing Calf Raises * Treadmill Walking * Mobilization techniques

Agility and perturbation training group; Routine physical therapy

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Sher Shah Road, Shadbagh

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (8)

• Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008 Oct 15;59(10):1488-94. doi: 10.1002/art.24118.

  PMID: 18821647 BACKGROUND

• Hicks-Little CA, Peindl RD, Hubbard-Turner TJ, Cordova ML. The Relationship Between Early-Stage Knee Osteoarthritis and Lower-Extremity Alignment, Joint Laxity, and Subjective Scores of Pain, Stiffness, and Function. J Sport Rehabil. 2016 Aug;25(3):213-8. doi: 10.1123/jsr.2014-0170. Epub 2016 Jul 21.

  PMID: 27445119 BACKGROUND

• Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Dtsch Arztebl Int. 2010 Mar;107(9):152-62. doi: 10.3238/arztebl.2010.0152. Epub 2010 Mar 5.

  PMID: 20305774 BACKGROUND

• Samson DJ, Grant MD, Ratko TA, Bonnell CJ, Ziegler KM, Aronson N. Treatment of primary and secondary osteoarthritis of the knee. Evid Rep Technol Assess (Full Rep). 2007 Sep;(157):1-157.

  PMID: 18088162 BACKGROUND

• Collins NJ, Hart HF, Mills KAG. Osteoarthritis year in review 2018: rehabilitation and outcomes. Osteoarthritis Cartilage. 2019 Mar;27(3):378-391. doi: 10.1016/j.joca.2018.11.010. Epub 2018 Dec 7.

  PMID: 30529739 BACKGROUND

• 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.

  PMID: 17719803 BACKGROUND

• 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.

  PMID: 17986496 BACKGROUND

• 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.

  PMID: 18279766 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maryam Ijaz, MSPT*

  Riphah International University,Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: June 30, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 10, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)