Balance Training Using Biodex Stability System in Knee Osteoarthritis.

NCT04019366 | Completed

• 1 other identifier: RiphahIU Samina Javed
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This was a randomized control Trial, conducted with two group of patients, one has received Balance and stability training on Biodex stability system along with conservative protocol of traditional exercises. the other group has received only conservative protocol of traditional exercises

Conditions

Knee Osteoarthritis

Keywords

Balance Training; Biodex stability system; Osteoarthrosis; Degenerative; Stability exercises

Outcome Measures

Primary Outcomes (8)

• Time up and Go test (TUG)

  Patients were asked to perform test at usual walking speed. Initial testing standardized verbal instructions given to the participant regarding procedure. For performing TUG participants were instructed to walk three meter and then, walk back to sit down. Note time on stopwatch. The average of tests trail was measured as the mean of TUG.

  Baseline

• Time up and Go test (TUG)

  Patients were asked to perform test at usual walking speed. Initial testing standardized verbal instructions given to the participant regarding procedure. For performing TUG participants were instructed to walk three meter and then, walk back to sit down. Note time on stopwatch. The average of tests trail was measured as the mean of TUG.

  Post 4th Week

• overall stability index (OSI)

  Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .94

  Baseline

• overall stability index (OSI)

  Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .94

  Post 4th Week

• Anterior-posterior stability index (APSI)

  Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .95

  Baseline

• Anterior-posterior stability index (APSI)

  Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .95

  Post 4th Week

• Medial-lateral stability index (MLSI)

  Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .93

  Baseline

• Medial-lateral stability index (MLSI)

  Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .93

  Post 4th Week

Secondary Outcomes (4)

• Numeric Pain Rating Scale (NPRS)

  Baseline

• Numeric Pain Rating Scale (NPRS)

  post 4th week

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Baseline

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Post 4th week

Study Arms (2)

Group I

EXPERIMENTAL

The experimental group was treated with Balance Training on Biodex Stability System along with traditional exercises.

Other: Balance Training

Group II

ACTIVE COMPARATOR

The Control group was treated with Traditional exercises only for Symptomatic knee osteoarthritis.

Other: Conventional Training

Interventions

Balance Training OTHER

Experimental group received balance training on Biodex stability System along with traditional exercise program. During balance training on Biodex, patients were instructed to stand on the platform with bare feet with open eyes and both legs supported. Patients were looking forward to screen having hands hang by the sides. The patients were instructed not to change their feet position and balance the body. The handles were accessible for safety point. But touching the handles cancelled the trail. Total time of training was 10 minutes each set is of 3 minutes with 20 sec rest intervals.

Group I

Conventional Training OTHER

Control group has received traditional exercises i.e Quadriceps strength exercises, Hamstrings flexibility exercises and Balance exercises.

Group II

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral knee pain
• Age 35-65, Both genders
• Grade 2 or 3 on Kellgren classification for Knee Arthritis

You may not qualify if:

• Past history of total knee artthroplasty
• Intra articular steroid injection
• Rheumatoid Arthritis
• Use of Assistive devices e.g. canes, walkers and braces
• Knee injury

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Armed forces Institute of Rehabilitation Medicine (AFIRM)

Islamabad, 44000, Pakistan

Location

Related Publications (4)

• Baldwin SL, Das JP. Atmospheric Ar and Ne returned from mantle depths to the Earth's surface by forearc recycling. Proc Natl Acad Sci U S A. 2015 Nov 17;112(46):14174-9. doi: 10.1073/pnas.1424122112. Epub 2015 Nov 5.

  PMID: 26542683 BACKGROUND

• Huang MH, Lin YS, Yang RC, Lee CL. A comparison of various therapeutic exercises on the functional status of patients with knee osteoarthritis. Semin Arthritis Rheum. 2003 Jun;32(6):398-406. doi: 10.1053/sarh.2003.50021.

  PMID: 12833248 BACKGROUND

• Chuang SH, Huang MH, Chen TW, Weng MC, Liu CW, Chen CH. Effect of knee sleeve on static and dynamic balance in patients with knee osteoarthritis. Kaohsiung J Med Sci. 2007 Aug;23(8):405-11. doi: 10.1016/S0257-5655(07)70004-4.

  PMID: 17666307 BACKGROUND

• Eftekhar-Sadat B, Azizi R, Aliasgharzadeh A, Toopchizadeh V, Ghojazadeh M. Effect of balance training with Biodex Stability System on balance in diabetic neuropathy. Ther Adv Endocrinol Metab. 2015 Oct;6(5):233-40. doi: 10.1177/2042018815595566.

  PMID: 26445646 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Huma Riaz, PHD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were masked from the treatment procedure by Sealed envelope methods. Patients were randomly distributed into two groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment of patients into two groups

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 15, 2019
• Study Start: February 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)